Pharmacovigilance QPPV, LQPPV, LCPPV Guide – All Countries

Pharmacovigilance plays a critical role in ensuring the safety and efficacy of medicines worldwide. The Qualified Person for Pharmacovigilance (QPPV), Local Qualified Person for Pharmacovigilance (LQPPV), and Local Contact Person for Pharmacovigilance (LCPPV) are key roles designed to ensure compliance with regulatory requirements and promote effective drug safety monitoring. These roles facilitate communication between pharmaceutical companies, healthcare providers, and regulatory authorities to identify, assess, and prevent adverse drug reactions (ADRs).

In this comprehensive guide, we provide an overview of pharmacovigilance requirements and the roles of QPPV, LQPPV, and LCPPV across all countries from. This resource will help pharmaceutical organizations and professionals navigate global regulatory frameworks, ensuring adherence to country-specific pharmacovigilance guidelines.

Comprehensive QPPV, LQPPV, LCPPV Requirements Guide 2024-2025: Global Pharmacovigilance Insights for 195 Countries (from A to Z)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «A» (Afghanistan, Albania,..)

Сomplete list of countries: Afghanistan, Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Austria, Azerbaijan.

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Afghanistan

NCA: The Drug Control Directorate under the Ministry of Public Health (MoPH)

QPPV/LQPPV/LCPPV Requirements:

Afghanistan does not require the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). Regulatory authority aims to oversee medical products and ensure that drugs are manufactured to meet internationally recognized standards.

Normative Documents:

Afghanistan’s regulatory processes comply with guidelines set forth by the World Health Organization (WHO) and other international bodies.

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Albania

NCA: The National Agency for Medicines and Medical Devices (AKBPM)

QPPV/LQPPV/LCPPV Requirements: Qualified Person for Pharmacovigilance (QPPV): Marketing Authorization Holders (MAHs) are required to appoint a QPPV who is a resident of Albania. The QPPV must have completed studies in medicine, pharmacy, or dentistry, and possess specialized training or certified expertise in pharmacovigilance. This individual is responsible for establishing and maintaining the pharmacovigilance system.

Normative Documents:

Law No. 105/2014 “On Medicinal Products and Pharmaceutical Service”: Chapter XI, Article 57 of this law defines the pharmacovigilance sector in Albania. Recent amendments in December 2022 have introduced specific timelines for reporting adverse drug reactions (ADRs):

Unexpected adverse effects must be reported within 24 hours from day zero.
Serious ADRs within 15 days from day zero.
Other adverse effects within 90 days from day zero.

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Algeria

NCA: The Centre National de Pharmacovigilance et de Matériovigilance (CNPM) under the Ministry of Health, Population, and Hospital Reform (MSPRH)

QPPV/LQPPV/LCPPV Requirements:

Local Contact Person for Pharmacovigilance (RPV): Marketing Authorization Holders (MAHs) are required to appoint a Responsible Person for Pharmacovigilance (RPV) who resides in Algeria. If the primary RPV is based outside Algeria, the company must designate a local contact person to liaise between the CNPM and the international pharmacovigilance head. This ensures effective communication and compliance with local pharmacovigilance obligations.
Pharmacovigilance System Master File (PSMF): MAHs must maintain a PSMF that details their pharmacovigilance system, including procedures, roles, and responsibilities. The PSMF should be readily available for review by the CNPM upon request

Normative Documents:

Algerian Guide on Pharmacovigilance (2019): This comprehensive guide outlines the national pharmacovigilance system, stakeholder roles, and obligations for the pharmaceutical industry. It covers topics such as procedures, audits, inspections, risk management plans (RMPs), periodic safety update reports (PSURs), and signal management.

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Andorra

NCA: The Ministry of Health of Andorra

QPPV/LQPPV/LCPPV Requirements: Andorra does not mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV) for Marketing Authorization Holders (MAHs). Pharmaceutical companies operating within Andorra are required to comply with the country’s regulatory framework, which emphasizes the safety, efficacy, and quality of drugs available in the market.

Normative Documents:

Law on the Regulation of Medicines and Pharmaceutical Specialties: This law ensures that all medicinal products undergo thorough evaluation before gaining approval for use. It outlines the processes for drug registration, mandating that pharmaceutical companies submit detailed evidence demonstrating the safety and effectiveness of their products.
Good Manufacturing Practices (GMP): Compliance with manufacturing quality standards is enforced through regulations derived from GMP, ensuring that pharmaceuticals not only meet initial approval criteria but continue to uphold quality and safety standards throughout their lifecycle.
Pharmacovigilance and Adverse Drug Reaction Monitoring: Regulations control advertising practices, pharmacovigilance, and the monitoring of adverse drug reactions, emphasizing transparency and documentation, requiring meticulous record-keeping from manufacturers and distributors to facilitate inspections and audits.

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Angola

NCA: The Regulatory Agency for Medicines and Healthcare Technologies (ARMED) under the Ministry of Health (Ministério da Saúde – MINSA).

QPPV/LQPPV/LCPPV Requirements: As of the latest information, Angola does not mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV) for Marketing Authorization Holders (MAHs). However, pharmaceutical companies are encouraged to establish internal pharmacovigilance systems to monitor and report adverse drug reactions (ADRs) and ensure the safety of their products. The Ministry of Health, with support from the World Health Organization (WHO), is actively working to strengthen the medicines regulatory system, including pharmacovigilance capacities, to ensure the availability of quality medicines for the population.

Normative Documents:

Presidential Decree No. 253/21 of 14 October 2021: This decree outlines the scope of pharmaceutical surveillance in Angola, emphasizing the importance of monitoring the safety and efficacy of medicines and health technologies.
Presidential Decree No. 315/20 of 17 December 2020: This decree governs the registration of medicines and health technologies, detailing the requirements for laboratory testing, labeling in Portuguese, and compliance with established norms and standards.
Presidential Decree No. 426/21 of 16 September 2021: This decree enforces the establishment of a list of pharmaceuticals considered priority, essential, and necessary for Angola, based on the country’s epidemiological status.

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Antigua and Barbuda

NCA: The Ministry of Health, Wellness, and the Environment

QPPV/LQPPV/LCPPV Requirements: As of the latest information, Antigua and Barbuda do not mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV) for Marketing Authorization Holders (MAHs). However, the country is actively working towards establishing a robust pharmacovigilance system. In 2018, representatives from Antigua and Barbuda participated in an international meeting on pharmacovigilance, with the objective of developing a national pharmacovigilance center and implementing a reporting mechanism involving healthcare professionals and patients.

Normative Documents:

Pharmacy Act, 1995 (No. 11 of 1995): This act provides the legal framework for the regulation of pharmacy practice in Antigua and Barbuda. It outlines the responsibilities of the Pharmacy Council and the requirements for the registration and operation of pharmacies.
Pharmacy (Amendment) Act, 2019 (No. 13 of 2019): This amendment updates the original Pharmacy Act to address contemporary challenges and improve the regulation of pharmaceutical practices in the country.
Pharmacy Regulations, 2012: These regulations provide detailed guidelines on the implementation of the Pharmacy Act, including standards for pharmacy operations, licensing procedures, and professional conduct.

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Argentina

NCA: The National Administration of Drugs, Food, and Medical Technology (ANMAT)

QPPV/LQPPV/LCPPV Requirements: In Argentina, Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person for Pharmacovigilance (QPPV). The QPPV is responsible for establishing and maintaining the pharmacovigilance system, ensuring compliance with regulatory requirements, and serving as the primary contact point for ANMAT regarding pharmacovigilance matters.

Normative Documents:

Argentina pharmacovigilance guidelines DISPOSICIÓN 2438/2000
Argentina pharmacovigilance guidelines DISPOSICIÓN 3870/1999

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Armenia

NCA: The Scientific Center of Drug and Medical Technology Expertise (SCDMTE) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:
MAHs are required to establish and maintain a pharmacovigilance system in accordance with the Good Pharmacovigilance Practices (GVP) adopted by the Eurasian Economic Union (EAEU). This includes the appointment of a LCPPV responsible for pharmacovigilance activities within the country.

Normative Documents:

Law on Medicinal Products (2016): Establishes the legal basis for the regulation of pharmaceutical activities in Armenia, including the requirements for the registration, manufacture, and distribution of medicinal products.
Requirements to the Registration of Medicinal Products in the Republic of Armenia (2010): Provides detailed guidelines on the procedures for state registration of medicinal products, including the necessary documentation and assessment criteria.
Good Manufacturing Practice (GMP) Guidelines: Manufacturers are required to comply with GMP standards to ensure the quality of medicinal products throughout their lifecycle.

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Australia

NCA: The Therapeutic Goods Administration (TGA)

QPPV/LQPPV/LCPPV Requirements: In Australia, sponsors (i.e., Marketing Authorization Holders) of medicines included on the Australian Register of Therapeutic Goods (ARTG) must have a pharmacovigilance system that meets specific requirements. One of these requirements is to have a designated Qualified Person for Pharmacovigilance (QPPV) responsible for overseeing the pharmacovigilance system within the organization. The QPPV ensures regulatory compliance and the effectiveness of the sponsor’s pharmacovigilance system.

Normative Documents:

Pharmacovigilance Responsibilities of Medicine Sponsors: This guidance document sets out the pharmacovigilance responsibilities of sponsors of medicines included on the ARTG and regulated by the TGA. It outlines the mandatory reporting requirements and offers recommendations on pharmacovigilance best practices.
Therapeutic Goods Act 1989: This act provides the legal framework for the regulation of therapeutic goods in Australia, including provisions related to pharmacovigilance.
Therapeutic Goods Regulations 1990: These regulations complement the Therapeutic Goods Act and provide detailed requirements for the implementation of pharmacovigilance activities.

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Austria

NCA: The Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) and Austrian Medicines and Medical Devices Agency (AGES MEA)

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in Austria are required to have a QPPV who is responsible for the establishment and maintenance of the pharmacovigilance system. The QPPV must reside within the European Economic Area (EEA) and is accountable for ensuring compliance with pharmacovigilance obligations.
There is no legal requirement to appoint an LCPPV, the AGES can request the nomination of an LCPPV.

Normative Documents:

Austrian Medicines Act (Arzneimittelgesetz): This act provides the legal framework for pharmacovigilance activities in Austria, aligning with European Union regulations to ensure the safety of medicinal products.
Good Pharmacovigilance Practice (GVP) Guidelines: Austria adheres to the EU’s GVP guidelines, which outline the responsibilities and requirements for pharmacovigilance systems, including the roles of the QPPV and LCPPV.

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Azerbaijan

NCA: The Analytical Expertise Center (AEC) under the Ministry of Health of the Republic of Azerbaijan

QPPV/LQPPV/LCPPV Requirements:

In Azerbaijan, both Marketing Authorization Holders (MAHs) and healthcare institutions are required to appoint a person responsible for pharmacovigilance. This individual, often referred to as the Qualified Person for Pharmacovigilance (QPPV) or Local Qualified Person for Pharmacovigilance (LQPPV), must possess a medical or pharmacy background. Their responsibilities include:

Establishing and maintaining a pharmacovigilance system within their organization.
Reporting Individual Case Safety Reports (ICSRs) to the AEC’s pharmacovigilance department.
Responding promptly to any safety concerns or crises related to medicinal products.
Participating in training programs on pharmacovigilance organized by the regulatory authorities.

This requirement ensures that both MAHs and healthcare institutions actively contribute to the national pharmacovigilance system.

Normative Documents:

Resolution No. 503 (December 25, 2019): Titled “Regulations of the Pharmacovigilance of Medicinal Products,” this resolution establishes the framework for state control over the effectiveness and safety of medicinal products in Azerbaijan. It outlines the responsibilities of MAHs, healthcare institutions, and regulatory authorities in conducting pharmacovigilance activities.
Resolution No. 39 (August 25, 2020): This resolution approves the “Guidelines for Good Pharmacovigilance Practice” (GVP) in Azerbaijan. The guidelines provide detailed procedures for detecting, evaluating, and preventing adverse reactions and other drug-related problems, ensuring alignment with international standards.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «B» (Bahamas, Bahrain,..)

Сomplete list of countries: Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi.

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Bahamas

NCA: The Bahamas Pharmacy Council under the Ministry of Health and Wellness

QPPV/LQPPV/LCPPV Requirements: N/A

Normative Documents:

Pharmacy Act: Establishes the legal basis for the regulation of pharmacy practice, including the establishment of the Bahamas Pharmacy Council and its functions.
Pharmacy (Registration and Licensing) Regulations: Detail the procedures for the registration and licensing of pharmacists and pharmacies, ensuring adherence to professional standards.

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Bahrain

NCA: The National Health Regulatory Authority (NHRA)

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in Bahrain are required to establish a pharmacovigilance system to monitor the safety of their products post-marketing and the appointment of a QPPV with appropriately qualified and experienced in pharmacovigilance and must be readily available to communicate with NHRA.

Normative Documents:

Medicine Licensing Guideline: This document outlines the requirements and procedures for obtaining marketing authorization for medicinal products in Bahrain.
Medicine Variations Guideline: Provides guidance on the procedures for submitting variations to existing marketing authorizations.
Medicines Barcoding and Serialization Guideline: Mandates the use of GS1 DataMatrix barcodes on pharmaceutical packaging to enhance traceability and combat counterfeit medicines.

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Bangladesh

NCA: The Directorate General of Drug Administration (DGDA), which operates under the Ministry of Health & Family Welfare

QPPV/LQPPV/LCPPV Requirements:

QPPV appointment is required and should be appropriately qualified and experienced in pharmacovigilance and must be readily available to communicate with DGDA.

Normative Documents:

National Guideline on the Pharmacovigilance System in Bangladesh: This document provides a basic framework for the detection, assessment, understanding, and prevention of adverse effects of pharmaceutical products.
Good Pharmacovigilance Practices (GVP) Guideline: Developed by DGDA, this guideline outlines the requirements for MAHs in establishing and maintaining a pharmacovigilance system, including the roles and responsibilities of the QPPV.

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Barbados

NCA: The Barbados Drug Service (BDS) under the Ministry of Health and Wellness

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for a QPPV/LQPPV/LCPPV are not detailed in the available sources.

Normative Documents:

Drug Service Act Cap 40A: This act establishes the legal basis for the operations of the Barbados Drug Service, outlining its responsibilities and authority in managing the pharmaceutical sector.
Health Services Act Cap 44: This act articulates the Ministry of Health and Wellness’s role in public health, including the control of food and drugs to protect public health.
Barbados National Drug Formulary (BNDF): The BNDF is a comprehensive list of approved pharmaceuticals for use within Barbados, maintained and regularly updated by the BDS to reflect current medical standards and practices.

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Belarus

NCA: Center for Expertise and Testing in Healthcare under the Ministry of Health of the Republic of Belarus

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in Belarus are required to establish and maintain a pharmacovigilance system in accordance with the Good Pharmacovigilance Practices (GVP) adopted by the Eurasian Economic Union (EAEU). This includes the appointment of a LCPPV responsible for pharmacovigilance activities within the country.

Normative Documents:

Law on Pharmaceuticals: This law establishes the legal framework for the regulation of pharmaceuticals in Belarus, including provisions related to pharmacovigilance activities.
Instruction on the Procedure for Reporting Adverse Reactions to Pharmaceuticals: This document outlines the specific requirements and processes for reporting adverse events associated with pharmaceutical products in Belarus.
EAEU Good Pharmacovigilance Practices (GVP): As a member state of the EAEU, Belarus has adopted the EAEU GVP, which aims to harmonize pharmacovigilance practices across member countries.

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Belgium

NCA: The Federal Agency for Medicines and Health Products (FAMHP)

QPPV/LQPPV/LCPPV Requirements:

Appointment of a QPPV who resides within the European Economic Area (EEA) and designation of a LCPPV in Belgium are required.

Normative Documents:

Good Pharmacovigilance Practices (GVP): These EU guidelines provide comprehensive instructions on conducting pharmacovigilance activities.
Royal Decree of 14 December 2006 concerning medicines for human and veterinary use: This decree outlines specific national requirements, including the obligation for MAHs to appoint a local contact person for pharmacovigilance.
Circular 600: Provides detailed information regarding the obligation for the MAH to notify the local contact person and current information regarding pharmacovigilance to the FAMHP.

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Belize

NCA: The Drug Inspectorate Unit and the Pharmacy Unit under the Ministry of Health & Wellness

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for a QPPV/LQPPV/LCPPV are not detailed in the available sources.

Normative Documents:

Food and Drugs Act (Chapter 291): This act provides the legal basis for the regulation of food and drugs in Belize, ensuring that products meet safety and quality standards.
Chemists and Druggists Act (Chapter 311): This act regulates the practice of chemists and druggists, including the sale and dispensing of medicines.
Misuse of Drugs Act (Chapter 103): This act controls the distribution and use of certain drugs to prevent misuse and ensure public safety.
Food and Drugs (Registration, Licensing, and Inspection) Regulations (2017): These regulations establish the procedures for the registration, licensing, and inspection of food and drug products, including the establishment of drug registry.

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Benin

NCA: The Benin Product Regulatory Authority, known as BSO (Bureau de la Santé et de l’Ordre)

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for a QPPV/LQPPV/LCPPV are not detailed in the available sources.

Normative Documents:

BSO has developed a comprehensive set of guidelines to assist stakeholders in the pharmaceutical sector. www.bsogov.org

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Bhutan

NCA: The Drug Regulatory Authority (DRA) under the Bhutan Medicines Board (BMB)

QPPV/LQPPV/LCPPV Requirements:

Requirements for a QPPV/LQPPV/LCPPV are not detailed in the available sources.

Normative Documents:

Bhutan Medicines Rules and Regulation 2019: Provides comprehensive regulations on the control and management of medicinal products in Bhutan.
Guideline for Registration of Medicinal Products 2020: Offers detailed procedures for registering medicinal products, ensuring they meet quality, safety, and efficacy standards.
Guideline for Regulating Health Supplements: Outlines the regulatory framework for health supplements to ensure their safety and quality.
Pharmacovigilance Guide for Adverse Drug Reaction Monitoring and Causality Assessment 2017: Provides guidance on monitoring and assessing adverse drug reactions to enhance patient safety.

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Bolivia

NCA: The State Agency for Medicines and Health Technologies (Agencia Estatal de Medicamentos y Tecnología en Salud, AGEMED) under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV/LQPPV/LCPPV are not explicitly defined in Bolivian regulations. However, AGEMED mandates that pharmaceutical companies establish robust pharmacovigilance systems to monitor and report adverse drug reactions. Companies are expected to designate qualified personnel responsible for these activities to ensure patient safety and regulatory compliance.

Normative Documents:

Law No. 1737 (Medicines Law): Establishes the legal basis for the regulation of medicines and pharmaceutical activities in Bolivia.
Supreme Decree No. 25235: Provides detailed regulations concerning sanitary registrations, authorizations, imports, and other related aspects.
Ministerial Resolution No. 0909 (Manual for Sanitary Registration of Medicines): Outlines the procedures and requirements for obtaining sanitary registration for pharmaceutical products.
Administrative Resolution No. 886 (Guide for Medicines Stability Studies): Sets forth guidelines for conducting stability studies to determine the shelf life of pharmaceutical products, ensuring their safety and efficacy throughout the distribution period.

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Bosnia and Herzegovina

NCA: The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBiH)

QPPV/LQPPV/LCPPV Requirements:

While specific roles such QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources, ALMBiH mandates that marketing authorization holders report any adverse events or effects of medicinal products and periodically submit Periodic Safety Update Reports (PSURs). This requirement implies that companies should have qualified personnel responsible for pharmacovigilance activities to ensure compliance with national regulations.

Normative Documents:

Medicinal Product and Medical Devices Act: Drafted in accordance with EU Directive 2001/83/EC, this act serves as the foundational legal framework for the regulation of medicinal products and medical devices in the country.
Regulations (Sublegal Acts): These are drafted in alignment with applicable European regulations, directives, and guidelines, ensuring harmonization with EU standards.
Good Manufacturing Practice (GMP) Guidelines: Manufacturers are required to comply with GMP standards to ensure product quality and safety.
Guidelines for Medical Device Registration: These provide orientation regarding regulatory requirements for the registration of medical device manufacturers in Bosnia and Herzegovina.

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Botswana

NCA: The Botswana Medicines Regulatory Authority (BoMRA)

QPPV/LQPPV/LCPPV Requirements:

While specific roles such as QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources, BoMRA mandates that Marketing Authorization Holders (MAHs) establish robust pharmacovigilance systems. This includes the safety monitoring of human medicines, vaccines, veterinary medicines, and medical devices. MAHs are expected to report adverse drug reactions and comply with post-market surveillance regulations.

Normative Documents:

Guidelines for Product Evaluation and Registration: Provides procedures for the registration of human medicines, veterinary medicines, complementary medicines, cosmetics, and medical devices.
Pharmacovigilance Guidelines for MAHs: Outlines the responsibilities of Marketing Authorization Holders in monitoring the safety of their products and reporting adverse events.
Post-Market Surveillance Regulations: Details the requirements for ongoing monitoring of product quality and safety aftermarket authorization.

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Brazil

NCA: The Brazilian Health Regulatory Agency (Anvisa)

QPPV/LQPPV/LCPPV Requirements:

In Brazil, the role equivalent to the QPPV is defined under Anvisa’s regulations. Marketing Authorization Holders (MAHs) are required to designate a pharmacovigilance officer responsible for the establishment and maintenance of a pharmacovigilance system. This individual must ensure compliance with Good Pharmacovigilance Practices (GVP) and is accountable for the collection, evaluation, and reporting of adverse events associated with medicinal products. The specific qualifications and responsibilities of this role are detailed in Anvisa’s regulatory framework.

Normative Documents:

Resolution RDC No. 406/2020: This resolution outlines Good Pharmacovigilance Practices for holders of marketing authorizations for human medicines. It specifies the requirements, responsibilities, and standards to be observed to ensure the safety and efficacy of medicinal products.
Normative Instruction No. 63/2020: This instruction provides guidance on the Periodic Benefit-Risk Evaluation Report (PBRER) that must be submitted to Anvisa by holders of marketing authorizations for human medicines. It details the format, content, and submission timelines for these reports.
Guidelines on Regulatory Reliance (2024): Anvisa has published guidelines to optimize the approval process for drug products, biological products, and vaccines by leveraging assessments from equivalent foreign regulatory authorities. This approach aims to enhance regulatory efficiency and ensure timely access to essential medicines.

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Brunei

NCA: The Department of Pharmaceutical Services (DPS) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources.

Normative Documents:

Medicines Order, 2007: Establishes the legal basis for the regulation of medicinal products in Brunei.
Medicines (Licensing, Standard Provisions and Fees) Regulations, 2010: Details the licensing requirements and standard provisions for medicinal products.
Medicines (Labelling) Regulations, 2010: Specifies the labeling requirements for medicinal products to ensure proper identification and usage.
Poisons Act, 1956: Regulates the control and distribution of poisons and hazardous substances.
ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR): Brunei, as a member of the Association of Southeast Asian Nations (ASEAN), adopts these guidelines for the registration of pharmaceutical products, ensuring harmonization with regional standards.

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Bulgaria

NCA: The Bulgarian Drug Agency (BDA) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

As a member of the European Union, Bulgaria adheres to EU pharmacovigilance requirements. Marketing Authorization Holders (MAHs) are required to appoint a QPPV/LQPPV/LCPPV.

Normative Documents:

Medicinal Products in Human Medicine Act: This act serves as the foundational legal framework for the regulation of medicinal products in Bulgaria.
Regulation No 15/2009: Outlines the requirements for granting manufacturing and import authorizations and the principles of Good Manufacturing Practice for all types of medicinal products.
Regulation No 27/2007: Specifies the requirements for the data and documentation necessary for marketing medicinal products.
Guidelines on Good Distribution Practice (GDP): These guidelines provide principles of GDP for medicinal products for human use, ensuring that the quality and integrity of medicines are maintained throughout the distribution chain.

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Burkina Faso

NCA: The Directorate General of Pharmacy, Medicines, and Laboratories (DGPML) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources.

Normative Documents:

Medicines and Related Substances Act: Establishes the legal basis for the regulation of medicinal products in Burkina Faso.
Good Manufacturing Practices (GMP) Guidelines: While not yet formally considered in the regulations, there are efforts to incorporate GMP standards for manufacturers.
Pharmacovigilance Guidelines: Outline the requirements for monitoring and reporting adverse drug reactions.
Clinical Trial Regulations: Mandate authorization from the DGPML and approval from an ethics committee for conducting clinical trials.

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Burundi

NCA: The Department of Pharmacy, Medicines, and Laboratories (DPML) under the Ministry of Public Health and the Fight against AIDS

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as Qualified Person for Pharmacovigilance (QPPV) are not explicitly detailed in the available sources.

Normative Documents:

Medicines and Related Substances Act: Establishes the legal basis for the regulation of medicinal products in Burundi.
Good Manufacturing Practices (GMP) Guidelines: While not yet formally considered in the regulations, there are efforts to incorporate GMP standards for manufacturers.
Pharmacovigilance Guidelines: Outline the requirements for monitoring and reporting adverse drug reactions.
Clinical Trial Regulations: Mandate authorization from the DPML and approval from an ethics committee for conducting clinical trials.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «C» (Cabo Verde, Cambodia,..)

Сomplete list of countries: Cabo Verde, Cambodia, Cameroon, Canada, Central African Republic, Chad, Chile, China, Colombia, Comoros, Congo Republic, Democratic Republic of the Congo, Costa Rica, Côte d’Ivoire, Croatia, Cuba, Cyprus, Czech Republic.

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Cabo Verde

NCA: The Entidade Reguladora Independente da Saúde (ERIS)

QPPV/LQPPV/LCPPV Requirements:

Cabo Verde has established a National Pharmacovigilance System under Decree-Law No. 17/2017, which outlines the responsibilities of various stakeholders in monitoring drug safety. While specific requirements for a Qualified Person for Pharmacovigilance (QPPV) are not detailed, the legislation emphasizes the importance of healthcare professionals and pharmaceutical companies in reporting adverse drug reactions (ADRs) and other drug-related problems.

Normative Documents:

Decree-Law No. 17/2017: Establishes the National Pharmacovigilance System and its operational rules.
Regulation on Pharmacovigilance: Approved by Deliberation No. 05/2017, this regulation details the procedures for monitoring drug safety.
National Pharmaceutical Policy (2018–2028): Outlined in Cabinet Resolution 83/2018, it identifies areas for intervention to strengthen the pharmaceutical sector.

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Cambodia

NCA: The Department of Drugs and Food (DDF) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Currently Cambodia does not have specific requirements mandating the appointment of QPPV/LQPPV/LCPPV.

Normative Documents:

Guidelines on Registration of Therapeutic Products in Cambodia (August 2019)
ASEAN Common Technical Dossier (ACTD) Guidelines:
Licensing Laws on the Management of Pharmaceuticals in Cambodia.

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Cameroon

NCA: The Department of Pharmacy, Medicines, and Laboratories (DPML) and the Cameroon Agency for Food and Drug Administration (FDA Cameroon) under the Ministry of Public Health (MINSANTE)

QPPV/LQPPV/LCPPV Requirements:

Currently Cambodia does not have specific requirements mandating the appointment of QPPV/LQPPV/LCPPV.

Normative Documents:

Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Cameroon
Guidelines for Good Clinical Practice (GCP) in Cameroon
Guidelines for Conduct of Clinical Trials in Pediatric Population:
Guideline for Conduct of Clinical Trials During Emergencies.

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Canada

NCA: Health Canada

QPPV/LQPPV/LCPPV Requirements:

Health Canada does not specifically mandate the appointment of a QPPV. However, MAHs must have adequate personnel and systems in place to fulfill their pharmacovigilance obligations.

Normative Documents:

Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)
Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs):
Good Manufacturing Practices Guide for Drug Products (GUI-0001).

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Central African Republic

NCA: The Department of Pharmaceutical Services, Laboratories, and Traditional Medicine under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

The country does not have a national pharmacovigilance center. Consequently, there are no specific requirements for appointing a QPPV/LQPPV/LCPPV.

Normative Documents:

African Medicines Regulatory Harmonization (AMRH): African Union (AU) Model Law on Medical Products Regulation: In January 2016.

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Chad

NCA: The Sub-Directorate of Pharmacy and Medicines under the Ministry of Public Health

QPPV/LQPPV/LCPPV Requirements:

Specific requirements are not explicitly detailed in the available sources.

Normative Documents:

African Medicines Regulatory Harmonization (AMRH): African Union (AU) Model Law on Medical Products Regulation: In January 2016.

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Chile

NCA: The Instituto de Salud Pública (ISP) under the Ministry of Health (MoH)

QPPV/LQPPV/LCPPV Requirements:

As of the latest available information, Chilean regulations do not explicitly mandate the appointment of a QPPV/LQPPV/LCPPV.

Normative Documents:

Sanitary Code (Decree with Force of Law No. 725/67)
Supreme Decree No. 3/2010
Supreme Decree No. 825/1999
Technical Guidelines and Ancillary Regulations.

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China

NCA: National Medical Products Administration (NMPA)

QPPV/LQPPV/LCPPV Requirements:

In China, the role equivalent to the Qualified Person for Pharmacovigilance (QPPV) is the Responsible Person for Pharmacovigilance (RPPV). The RPPV is crucial in ensuring that the pharmacovigilance system operates in compliance with regulations and that the safety of marketed products is maintained.

Normative Documents:

Good Pharmacovigilance Practices (GVP): Issued by the NMPA, December 1, 2021
Pharmacovigilance Inspection Guidelines: Released by the NMPA in April 2022.

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Colombia

NCA: The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Colombian regulations do not explicitly mandate the appointment of a QPPV/LQPPV/LCPPV.

Normative Documents:

Decree 677 of 1995
Decree 1484 of 2012
Decree 4725 of 2005
Law 1751 of 2015.

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Comoros

NCA: The Agence Nationale des Médicaments et des Évacuations Sanitaires (ANAMEV)

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for appointing a QPPV/LQPPV/LCPPV are not explicitly detailed.

Normative Documents:

African Medicines Regulatory Harmonization (AMRH): African Union (AU) Model Law on Medical Products Regulation: In January 2016.

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Congo Republic

NCA: The Directorate of Pharmacies, Laboratories, and Medicines (DPLM), operating under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements: N/A

Efforts have been made to establish a national pharmacovigilance system to monitor the safety and efficacy of medicines. The establishment of such a system is crucial for detecting, assessing, and preventing adverse drug reactions.

Normative Documents:

African Medicines Regulatory Harmonization (AMRH): African Union (AU) Model Law on Medical Products Regulation: In January 2016.

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Congo Democratic Republic

NCA: The Directorate of Pharmacy, Medicines, and Traditional Medicine (DPMTM)

QPPV/LQPPV/LCPPV Requirements: N/A

The development of a pharmacovigilance system has been a significant focus, with the country managing to develop one of the most active pharmacovigilance systems despite resource limitations. The system is designed to monitor and evaluate adverse drug reactions to ensure patient safety.

Normative Documents:

African Medicines Regulatory Harmonization (AMRH): African Union (AU) Model Law on Medical Products Regulation: In January 2016.

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Costa Rica

NCA: The Ministry of Health (Ministerio de Salud)

QPPV/LQPPV/LCPPV Requirements:

Costa Rica mandates that Marketing Authorization Holders (MAHs) designate a responsible person for pharmacovigilance. This individual acts as the primary contact for the health authorities and oversees the safety profiles of marketed pharmaceutical products.

Normative Documents:

Decree No. 43590-S (June 30, 2022)
Central American Technical Regulation (RTCA).

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Côte d’Ivoire

NCA: The Ivorian Authority for Pharmaceutical Regulation (AIRP)

QPPV/LQPPV/LCPPV Requirements: N/A

Normative Documents:

African Medicines Regulatory Harmonization (AMRH): African Union (AU) Model Law on Medical Products Regulation: In January 2016
West Africa Medicines Regulatory Harmonization (MRH) program, 2015.

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Croatia

NCA: The Agency for Medicinal Products and Medical Devices (HALMED)

QPPV/LQPPV/LCPPV Requirements:

In Croatia, Marketing Authorization Holders (MAHs) are required to appoint a Local Contact Person for Pharmacovigilance (LCPPV) who resides in Croatia.

Normative Documents:

Medicinal Products Act
Ordinance on Pharmacovigilance
Good Pharmacovigilance Practices (GVP).

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Cuba

NCA: The Center for State Control of Medicines, Equipment, and Medical Devices (CECMED) under the Ministry of Public Health

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) are required to designate a responsible person for pharmacovigilance activities. This individual acts as the primary contact for health authorities and oversees the safety profiles of marketed pharmaceutical products.

Normative Documents:

Good Manufacturing Practices (GMP)
Clinical Trial Authorization
Pharmacovigilance Regulations.

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Cyprus

NCA: The Pharmaceutical Services of the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in Cyprus are required to appoint a Local Qualified Person for Pharmacovigilance (LQPPV) if the EU Qualified Person for Pharmacovigilance (QPPV) is not located in Cyprus.

Normative Documents:

Good Pharmacovigilance Practices (GVP)
National Legislation.

______________________________

Czech Republic

NCA: The State Institute for Drug Control (SÚKL)

QPPV/LQPPV/LCPPV Requirements:

QPPV resides within the European Union (EU) and LCPPV as the primary contact point for pharmacovigilance activities at the national level are required.

Normative Documents:

Good Pharmacovigilance Practices (GVP)
National Legislation.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Denmark, Djibouti, Dominica, Dominican Republic

Denmark

NCA: The Danish Medicines Agency (Lægemiddelstyrelsen)

QPPV/LQPPV/LCPPV Requirements: As a member of the European Union (EU), Denmark adheres to EU pharmacovigilance legislation. Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who is permanently and continuously at their disposal. The QPPV must reside within the European Economic Area (EEA) and is responsible for establishing and maintaining the MAH’s pharmacovigilance system, overseeing the safety profiles of the company’s products, and acting as a single contact point for the health authorities on a 24-hour basis.

Regarding the appointment of a Local Contact Person for Pharmacovigilance (LCPPV) in Denmark, the Danish Medicines Agency generally does not require the nomination of such a contact person unless it is considered necessary.

Normative Documents:

EU Good Pharmacovigilance Practices (GVP): These guidelines provide a comprehensive framework for the conduct of pharmacovigilance in the EU, detailing the responsibilities of MAHs, including the role of the QPPV.
Regulation (EC) No 726/2004: This regulation lays down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishes a European Medicines Agency.
Directive 2001/83/EC: This directive relates to the Community code concerning medicinal products for human use and outlines the legal framework for the authorization, manufacture, and distribution of medicinal products in the EU.

______________________________

Djibouti

NCA: The Djibouti Health Authority (DJHA)

QPPV/LQPPV/LCPPV Requirements: Djibouti does not have specific requirements mandating the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). However, the DJHA emphasizes compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) to ensure the quality and safety of pharmaceutical products. Manufacturers and distributors are expected to adhere to these practices to maintain product integrity throughout the supply chain.

Normative Documents:

Good Manufacturing Practices (GMP): These guidelines outline the necessary practices for ensuring product quality during manufacturing. Compliance with GMP is mandatory for all pharmaceutical manufacturers operating in Djibouti.
Good Distribution Practices (GDP): These guidelines ensure that the quality and integrity of pharmaceutical products are maintained throughout the distribution network. Adherence to GDP is required for all entities involved in the distribution of medicines in Djibouti.

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Dominica

NCA: The Dominica Pharmaceuticals Regulatory Authority (DPRA)

QPPV/LQPPV/LCPPV Requirements: Dominica does not mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). However, the DPRA emphasizes the importance of pharmacovigilance activities, including the monitoring of adverse drug reactions (ADRs) and ensuring the safety of pharmaceutical products throughout their lifecycle. Manufacturers and suppliers are expected to adhere to international best practices in pharmacovigilance to ensure patient safety.

Normative Documents:

Good Manufacturing Practices (GMP): Pharmaceutical companies in Dominica are required to adhere to strict manufacturing standards to ensure that products are safe, effective, and of high quality. Central to these standards is the implementation of GMP, which serves as a foundation for ensuring excellence in the pharmaceutical manufacturing process.
Importation and Distribution Regulations: Dominica has established regulatory frameworks governing the importation and distribution of pharmaceutical products to ensure the safety, efficacy, and quality of medications available in the country. Compliance with these regulations is essential for maintaining public health standards.

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Dominican Republic

NCA: General Directorate of Medicines, Food, and Health Products (DIGEMAPS) under the Ministry of Public Health and Social Assistance

QPPV/LQPPV/LCPPV Requirements: No explicit requirement for Marketing Authorization Holders (MAHs) to appoint a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). However, MAHs are expected to actively participate in pharmacovigilance activities, including the reporting of adverse drug reactions (ADRs) and ensuring the continuous monitoring of their products’ safety profiles.

Normative Documents:

Resolution No. 00017 (20 September 2017): This technical regulation defines pharmacovigilance within the national health system as a set of procedures and activities coordinated by the Pharmacovigilance Commission, aiming to collect, analyze, and elaborate information on adverse drug reactions.
Medicines Decree No. 246-06: Establishes the National Pharmacovigilance Commission, composed of pharmaceutical, chemical, medical, and other health sector professionals appointed by the Ministry of Public Health and Social Assistance. The commission advises and informs the ministry on matters related to the identification and evaluation of adverse effects associated with pharmacological treatments.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «E» (East Timor, Ecuador,..)

Сomplete list of countries: East Timor, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Eswatini, Ethiopia.

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East Timor (Timor-Leste)

NCA: The National Directorate of Pharmacy and Medicines (Direcção Nacional de Farmácia e Medicamentos, DNFM) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

As of the latest information, Timor-Leste does not have specific requirements for Marketing Authorization Holders (MAHs) to appoint a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). The pharmacovigilance system is in the developmental stage, with efforts underway to establish comprehensive guidelines and reporting mechanisms. In October 2021, the Ministry of Health, with technical assistance from the World Health Organization (WHO), conducted a workshop with private pharmacies, clinics, and drug importers to discuss draft guidelines for pharmacovigilance in Timor-Leste. This consultation aimed to develop a more comprehensive pharmacovigilance system involving relevant stakeholders.

Normative Documents:

While specific pharmacovigilance legislation is still under development, several documents provide a framework for pharmaceutical regulation in Timor-Leste:

National Action Plan on Antimicrobial Resistance (2017-2020): This plan highlights the establishment of the NRA and outlines responsibilities related to regulation, licensing, pharmacovigilance, and market authorization.
Pharmaceutical Law (Decree Law 12/2004): This decree law governs pharmaceutical activities in Timor-Leste, including the import and export of medicines and chemicals. It emphasizes the safe supply of drugs to ensure public health and outlines the regulatory responsibilities of the Ministry of Health.

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Ecuador

NCA: The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) under the Ministry of Public Health

QPPV/LQPPV/LCPPV Requirements:

In Ecuador, Marketing Authorization Holders (MAHs) are required to appoint a responsible person for pharmacovigilance. This individual acts as the single contact point for the competent authorities, has an overview of the safety profiles of the marketed pharmaceutical products, and is responsible for establishing, maintaining, and managing the MAH’s pharmacovigilance system.

Normative Documents:

Ecuador’s pharmacovigilance system is governed by the Organic Health Law and its regulations, which aim to ensure that only safe, effective, and high-quality medicines are marketed in the country. The National Pharmacovigilance System (SNFV) is structured to collect, evaluate, and record suspected adverse drug reactions reported by healthcare professionals, facilitating the early identification of potential risks associated with medication use.

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Egypt

NCA: The Egyptian Drug Authority (EDA)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Egypt are required to appoint a Qualified Person for Pharmacovigilance (QPPV). The QPPV is responsible for establishing and maintaining the pharmacovigilance system, ensuring compliance with regulatory requirements, and serving as the primary contact point for the EDA regarding pharmacovigilance matters. The QPPV must reside in Egypt and possess the necessary qualifications and expertise in pharmacovigilance.

Normative Documents:

Ministerial Decree 368/2012: This decree provides the legal framework for pharmacovigilance of pharmaceutical products for human use, including biological products, in Egypt. It outlines the responsibilities of MAHs and the regulatory authority in monitoring and ensuring drug safety.
Guideline on Good Pharmacovigilance Practice (GVP) in Egypt: This guideline offers comprehensive guidance on the application of good pharmacovigilance practices in Egypt. It aligns with international standards, particularly the European GVP guidelines, while adapting to the Egyptian context. The guideline covers various aspects of pharmacovigilance, including the roles and responsibilities of the QPPV, reporting requirements, and quality management systems.

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El Salvador

NCA: The National Directorate of Medicines (Dirección Nacional de Medicamentos, DNM)

QPPV/LQPPV/LCPPV Requirements: In El Salvador, Marketing Authorization Holders (MAHs) are required to appoint a Pharmacovigilance Referent, equivalent to a Qualified Person for Pharmacovigilance (QPPV). The Pharmacovigilance Referent must be a health professional (physician or pharmacist) residing in the country and capable of promptly liaising with the National Center for Pharmacovigilance (CNFV). Their responsibilities include:

Developing and maintaining the pharmacovigilance master plan and related procedures within their institution.
Serving as the primary contact with the CNFV and acting as the responsible person during inspections conducted by the DNM and CNFV.
Ensuring the timely collection, management, evaluation, and reporting of suspected adverse reactions to the CNFV.
Regularly reviewing global health alerts issued by regulatory agencies and reporting the actions taken in response to these alerts.

Normative Documents:

Technical Standard for Pharmacovigilance (2022): This standard establishes the provisions for organizing and operating technical and administrative processes related to pharmacovigilance for pharmaceutical products, natural products, vitamin supplements, vaccines, homeopathic products, and related donations manufactured, imported, exported, marketed, distributed, and dispensed in the national territory. It applies to all natural or legal persons providing health services and those involved in related processes.
Salvadoran Technical Regulation of Pharmaceutical Products (RTS 11.02.02:16): Approved in October 2016, this regulation aims to establish guidelines for detecting, quantifying, evaluating, analyzing, and preventing adverse drug reactions, events allegedly attributed to vaccination and immunizations, and other problems related to medicines for human consumption.

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Equatorial Guinea

NCA: The National Directorate of Pharmacy and Medicines (NDPM) Under the Ministry of Health and Social Welfare (MoHSW)

QPPV/LQPPV/LCPPV Requirements: As of the current information, Equatorial Guinea does not have specific requirements mandating Marketing Authorization Holders (MAHs) to appoint a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). The pharmacovigilance system is in the developmental stages, with ongoing efforts to establish comprehensive guidelines and reporting mechanisms. The country is expected to benefit from the African Union (AU) Model Law aimed at harmonizing medical products regulatory systems across Africa, which may influence future pharmacovigilance requirements.

Normative Documents:

Equatorial Guinea aligns its pharmaceutical regulations with guidelines set by regional and global health organizations, such as the African Medicines Agency (AMA) and the World Health Organization (WHO).

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Eritrea

NCA: The Eritrean Pharmacovigilance Centre (EPC) under the National Medicines and Food Administration (NMFA)

QPPV/LQPPV/LCPPV Requirements: As of the current information, Eritrea does not have specific requirements mandating Marketing Authorization Holders (MAHs) to appoint a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). The pharmacovigilance system in Eritrea is managed centrally by the EPC, which has made significant progress in monitoring and ensuring drug safety within the country.

Normative Documents:

Eritrea has developed a comprehensive pharmacovigilance system, with key strategies and guidelines to monitor and ensure the safety of medicines. The EPC has been commended for its progress in pharmacovigilance, integrating it fully into public health programs and achieving a mature system recognized by the World Health Organization (WHO).

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Estonia

NCA: The Pharmacovigilance Centre under the State Agency of Medicines (Ravimiamet)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Estonia are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who resides within the European Union (EU). Additionally, Estonian legislation mandates that MAHs designate an Estonian-speaking contact person for pharmacovigilance. This local contact is specifically responsible for providing information to prescribers regarding any safety risks associated with the use of medicines.

Normative Documents:

Estonia adheres to the European Medicines Agency’s (EMA) guidelines on Good Pharmacovigilance Practices (GVP). These guidelines provide a robust framework for pharmacovigilance systems and quality requirements across EU member states.

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Eswatini

NCA: The National Pharmacovigilance Centre (NPC) under the Ministry of Health (MoH)

QPPV/LQPPV/LCPPV Requirements: As of the current information, Eswatini does not mandate Marketing Authorization Holders (MAHs) to appoint a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). Pharmacovigilance activities are coordinated centrally by the NPC, which collaborates with various stakeholders, including public health programs and healthcare providers, to monitor and report adverse drug reactions (ADRs).

Normative Documents:

Medicines and Related Substances Control Act, 2016: This act provides the legal framework for the regulation of medicines and related substances in Eswatini. It includes provisions for the establishment of a national medicines regulatory authority and outlines the roles and responsibilities related to pharmacovigilance.
National Pharmacovigilance Policy and Implementation Framework (2021): Launched on December 6, 2021, this policy provides guidance for implementing pharmacovigilance activities in Eswatini. Its goal is to optimize medicinal product-related safety for all residents. The policy was developed in line with international and local medicinal product safety requirements, in consultation with the MoH, public health programs, and other stakeholders.

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Ethiopia

NCA: The Ethiopian Food and Drug Authority (EFDA)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Ethiopia are required to establish a pharmacovigilance system and appoint a Qualified Person for Pharmacovigilance (QPPV). The QPPV must be a healthcare professional with at least two years of experience in pharmacovigilance-related activities. Additionally, the QPPV should receive formal training in pharmacovigilance recognized by the EFDA. The QPPV should not be a freelance consultant but an employee of the MAH or its local representative.

Normative Documents:

National Pharmacovigilance Guideline: This guideline outlines the responsibilities of MAHs, healthcare professionals, and the EFDA in monitoring and reporting adverse drug events (ADEs). It specifies timelines for reporting ADEs and provides guidance on establishing a pharmacovigilance system.
Pharmacovigilance Directive No. 932/2022: Issued in accordance with Article 71(2) of the Ethiopian Food and Medicine Administration Proclamation No. 1112/2019, MAHs must report periodic safety update reports, individual case safety reports, and establish risk management plans for their products in line with national standards.
Guideline for Registration of Medicine (2024): This guideline provides comprehensive requirements for the registration of medicines in Ethiopia, including provisions related to pharmacovigilance obligations for MAHs.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Fiji, Finland, France

Fiji

NCA: The Fiji Medicines Regulatory Authority (Fiji MRA) under the Ministry of Health and Medical Services (MHMS)

QPPV/LQPPV/LCPPV Requirements: Fiji does not mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). However, the Fiji MRA emphasizes the importance of monitoring the safety of medicinal products. Manufacturers and suppliers are expected to adhere to international best practices in pharmacovigilance to ensure patient safety. The Fiji MRA’s guidelines for the prequalification of pharmaceutical products highlight the necessity for manufacturers to comply with Good Manufacturing Practices (GMP) and ensure the quality of their products.

Normative Documents:

Medicinal Products Act 2011: This act requires that every medicinal product for importation, manufacture, export, sale, or distribution in Fiji must be registered. The Fiji MRA manages the provisional registration of these products through its Online Services Portal.
Guideline for the Prequalification of Pharmaceutical Products for the Fiji Ministry of Health & Medical Services: This guideline outlines the process to ensure that medicines supplied to the MHMS are of acceptable quality, safety, and efficacy. It details the requirements for prequalification of manufacturers and finished pharmaceutical products.

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Finland

NCA: The Finnish Medicines Agency (Fimea)

QPPV/LQPPV/LCPPV Requirements: As a member of the European Union (EU), Finland adheres to EU pharmacovigilance legislation. Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who is permanently and continuously at their disposal. The QPPV must reside within the European Economic Area (EEA) and is responsible for establishing and maintaining the MAH’s pharmacovigilance system, overseeing the safety profiles of the company’s products, and acting as a single contact point for the health authorities on a 24-hour basis.

Normative Documents:

EU Good Pharmacovigilance Practices (GVP): These guidelines provide a comprehensive framework for the conduct of pharmacovigilance in the EU, detailing the responsibilities of MAHs, including the role of the QPPV.
Regulation (EC) No 726/2004: This regulation lays down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishes a European Medicines Agency.
Directive 2001/83/EC: This directive relates to the Community code concerning medicinal products for human use and outlines the legal framework for the authorization, manufacture, and distribution of medicinal products in the EU.

______________________________

France

NCA: The French National Agency for Medicines and Health Products Safety (ANSM)

QPPV/LQPPV/LCPPV Requirements: In France, Marketing Authorization Holders (MAHs) are required to have a Qualified Person Responsible for Pharmacovigilance (QPPV) at the European level, in accordance with EU regulations. Additionally, French regulations mandate the appointment of a local pharmacovigilance reference person, known as the “Personne de Référence en matière de Pharmacovigilance” (RPV). The RPV must be a physician or pharmacist residing and practicing in France with experience in pharmacovigilance. This individual is responsible for overseeing pharmacovigilance activities at the national level and ensuring compliance with both national and EU pharmacovigilance requirements.

Normative Documents:

Good Pharmacovigilance Practices (GVP): France has adopted the EU Good Pharmacovigilance Practices, which provide a comprehensive framework for pharmacovigilance activities. Additionally, ANSM has issued French-specific GVP guidelines to address national requirements and ensure harmonization with EU standards.
Public Health Code (Code de la Santé Publique): French pharmacovigilance obligations are detailed in the Public Health Code, particularly in Article R. 5121-164, which outlines the responsibilities of the RPV and the requirements for MAHs operating in France.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «G» (Gabon, Gambia,..)

Сomplete list of countries: Gabon, Gambia, Georgia, Germany, Ghana, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana.

__________________________________

Gabon

NCA: Direction de la Pharmacie, du Médicament et des Laboratoires (DPML) under the Ministère de la Santé (Ministry of Health)

QPPV/LQPPV/LCPPV Requirements:

A QPPV (Qualified Person for Pharmacovigilance) or its local equivalent (LQPPV, LCPPV) is generally required in many African jurisdictions to ensure robust pharmacovigilance systems.
Gabon, as part of the CEMAC (Economic and Monetary Community of Central Africa) region, often aligns with regional directives for pharmaceutical regulation, although each country maintains its own specific requirements.
Local Contact Person: Marketing Authorization Holders (MAHs) typically must appoint a local representative for pharmacovigilance in Gabon. This person is sometimes referred to as a Local QPPV (LQPPV) or Local Contact Person for Pharmacovigilance (LCPPV).
Qualifications: The local pharmacovigilance contact is usually required to be a licensed healthcare professional (often a pharmacist or physician) registered to practice in Gabon.
Residency: Many African NRAs, including Gabon’s, require the local pharmacovigilance contact to reside in-country, ensuring availability for any urgent safety communication or regulatory actions.

Normative Documents:

Law or Ordinance Governing Pharmaceutical Products
Ministerial Decrees or Arrêtés
Guidelines from DPML
EMAC / ECCAS Regional Directives

_________________________________

Gambia

NCA: Medicines Control Agency (MCA) under the Medicines and Related Products Act, 2014.

QPPV/LQPPV/LCPPV Requirements:

Local Pharmacovigilance Contact needed for adverse event reporting to the MCA.
Typically a registered pharmacist or physician residing in The Gambia.
Responsible for timely safety reporting, risk management, and liaison with the MCA.

Normative Documents:

Medicines and Related Products Act, 2014 – core legislation.
MCA Pharmacovigilance Guidelines – local reporting procedures and timelines.
ECOWAS/WAHO Guidance – regional harmonization efforts

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Georgia

NCA: State Regulation Agency for Medical and Pharmaceutical Activities under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health, and Social Affairs of Georgia.

QPPV/LQPPV/LCPPV Requirements:

Local contact for pharmacovigilance is not required. A qualified professional (often a pharmacist or physician) can be designated by MAH to handle adverse event reporting, liaise with authorities, and ensure pharmacovigilance compliance.

Normative Documents:

Law of Georgia on Medicines and Pharmaceutical Activities – core legal framework for drug regulation.
Ministry/Agency Guidelines & Circulars – detail PV reporting timelines and requirements.
Relevant International References – Georgia often aligns with WHO or certain EU guidelines for pharmacovigilance best practices.

________________________________

Germany

NCA: Federal Institute for Drugs and Medical Devices (BfArM) and Paul-Ehrlich-Institut (PEI) under the Federal Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Qualified Person for Pharmacovigilance (QPPV): An EU/EEA requirement. The QPPV must reside in the EU/EEA and be responsible for the pharmacovigilance system of the Marketing Authorization Holder (MAH).
A German-speaking contact is often necessary for communication with national competent authorities, although this can be the QPPV or a designated local PV contact in Germany.
Responsibilities include adverse event reporting, risk management, and maintaining the Pharmacovigilance System Master File (PSMF).

Normative Documents:

German Medicines Act (Arzneimittelgesetz, AMG) – the principal national law on medicinal products.
EU Directives & Regulations (e.g. Directive 2001/83/EC, Regulation (EC) No 726/2004) – define EU-wide pharmacovigilance requirements.
Good Pharmacovigilance Practices (GVP) – EU guidelines that detail the operational aspects of pharmacovigilance.
BfArM/PEI Guidance – supplementary national instructions, including reporting formats and specific timelines.

________________________________

Ghana

NCA: Food and Drugs Authority (FDA) under Ghana’s Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Local PV Contact (often a pharmacist or physician) must be designated by the Marketing Authorization Holder (MAH).
Responsible for adverse event reporting, risk management measures, and regular liaison with the FDA.
Must be resident in Ghana and registered with a relevant professional body.

Normative Documents:

Public Health Act, 2012 (Act 851) – Core legal framework for FDA’s authority.
FDA Guidelines – Specific directives on drug registration, safety reporting, and pharmacovigilance requirements.
ECOWAS/WAHO Harmonization Initiatives – Additional regional guidelines that may influence local regulatory requirements.

_________________________________

Greece

NCA: National Organization for Medicines (EOF / Εθνικός Οργανισμός Φαρμάκων) under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Qualified Person for Pharmacovigilance (QPPV): An EU requirement. The QPPV must be located within the EU/EEA.
Local Contact: In Greece, a local PV contact is typically required to liaise with EOF in Greek.
Responsibilities include adverse event reporting, risk management, and maintaining the Pharmacovigilance System Master File (PSMF).

Normative Documents:

Greek Medicines Legislation (aligned with EU Directive 2001/83/EC and Regulation (EC) No 726/2004).
EOF Guidelines & Circulars – country-specific instructions for pharmacovigilance, reporting formats, and timelines.
EU Good Pharmacovigilance Practices (GVP) – applicable in Greece as an EU member.

_________________________________

Grenada

NCA: Grenada does not maintain a standalone national medicines regulatory agency.

The Ministry of Health (MoH) oversees pharmaceuticals, with guidance from the Chief Medical Officer (CMO) and the Pharmacy Council.

QPPV/LQPPV/LCPPV Requirements:

There is no formal QPPV mandate akin to EU/EEA requirements.
Typically, local representation (e.g., a pharmacist or distributor) is required for product importation and liaison with health authorities.
Pharmacovigilance reporting is generally minimal; serious events may be handled through the MoH on a case-by-case basis.

Normative Documents:

Pharmacy Act (governing pharmacy practice, registration, and licensing).
Import/Export Guidelines issued by the Ministry of Health (covers permits and basic quality controls).
CARPHA/PAHO Guidance – Grenada may refer to regional guidelines via the Caribbean Public Health Agency (CARPHA) or Pan American Health Organization (PAHO).

_________________________________

Guatemala

NCA: The Department of Regulation and Control of Pharmaceutical and Related Products (Departamento de Regulación y Control de Productos Farmacéuticos y Afines) under Ministry of Public Health and Social Assistance (MSPAS)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV requirement, but a local representative (often a pharmacist or physician) is typically mandated for product registrations.
This local contact handles pharmacovigilance reporting, coordinates with MSPAS on adverse events, and ensures compliance with safety obligations.

Normative Documents:

Código de Salud (Health Code) – overarching health legislation.
Reglamentos / Regulations issued by MSPAS – define registration procedures, pharmacovigilance duties, and reporting timelines.
Official Gazette (Diario de Centro América) – publishes enacted laws, decrees, and updates.

_________________________________

Guinea

NCA: Direction Nationale de la Pharmacie et du Médicament (DNPM) under the Ministry of Health (Ministère de la Santé).

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system; however, a local contact (often a registered pharmacist or physician) is typically required for product registrations.
This local contact handles adverse event reports, coordinates with DNPM, and ensures compliance with local safety reporting obligations.
Reporting timelines and formats can vary but generally follow the national guidelines.

Normative Documents:

Pharmaceutical Law / Code Pharmaceutique (national legislation governing pharmacy practice and medicinal products).
Ministerial Decrees or Arrêtés – detail processes for drug registration, distribution, and pharmacovigilance obligations.
ECOWAS Directives – Guinea, as part of West Africa, may reference broader ECOWAS/WAHO harmonization frameworks for drug regulation and safety monitoring.

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Guinea-Bissau

NCA: Ministry of Public Health (Ministério da Saúde Pública)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system.
In practice, a local contact (often a pharmacist or medical practitioner) may be required for product registrations and to handle any adverse event reports.
Pharmacovigilance infrastructure is minimal; serious safety concerns typically escalate to the Ministry of Public Health or regional health organizations on a case-by-case basis.

Normative Documents:

Basic Pharmacy/Health Legislation: Decrees or statutes under the Ministry of Public Health regulating the importation, distribution, and sale of medicines.
Regional Directives (ECOWAS/WAHO): Guinea-Bissau aligns with West African harmonization efforts for drug registration and surveillance, where applicable.
WHO/Donor Guidelines: Ad hoc references to WHO standards, especially for essential medicines and safety monitoring.

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Guyana

NCA: Food and Drug Department under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system; however, a local representative (often a pharmacist or medical professional) is required for product registration and liaison with the regulator.
Adverse event reporting processes exist but may be less structured compared to developed regulatory frameworks. Serious safety concerns are typically escalated to the Food and Drug Department.

Normative Documents:

Food and Drug Act – Governs manufacturing, import, labeling, and distribution of pharmaceuticals.
Pharmacy and Poisons Act – Oversees pharmacy practice and licensing provisions.
Ministry of Health Guidelines – Provide procedures for drug registration and safety monitoring.
CARPHA/PAHO Guidelines – Regional (Caribbean) references that may influence local policies.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Haiti, Honduras, Hungary

Haiti

NCA: Directorate of Pharmacy, Medicine, and Traditional Medicine (DPM/MT) under the Ministry of Public Health and Population

QPPV/LQPPV/LCPPV Requirements: Haiti does not currently mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). However, the DPM/MT emphasizes the importance of pharmacovigilance activities. Healthcare professionals are encouraged to report adverse drug reactions (ADRs) using the designated notification form provided by the DPM/MT. This reporting system aids in regulatory decision-making to ensure medication safety.

Normative Documents:

National Pharmaceutical Policy (Politique Pharmaceutique Nationale): This document outlines the strategic directions for addressing key aspects of the pharmaceutical sector, including the legal framework, to ensure equitable access to quality pharmaceutical services for the Haitian population.
Essential Medicines List (Liste Nationale des Médicaments Essentiels – LNME): The LNME is a list of medicines considered essential for addressing the primary healthcare needs of the population, ensuring their availability and rational use.
Pharmacovigilance Notification Form: The DPM/MT provides a standardized form for healthcare professionals to report ADRs related to medicines and other health products. This form is crucial for collecting data to monitor and evaluate medication safety.

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Honduras

NCA: The National Directorate for Medicines (Dirección Nacional de Medicamentos – DNAM) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements: Honduras does not currently mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV). The country has a low level of pharmacovigilance regulatory requirements, and formal systems for adverse event reporting are not well established.

Normative Documents:

Specific normative reference documents related to pharmacovigilance in Honduras are limited due to the nascent state of the pharmacovigilance system. However, the country is encouraged to develop and harmonize its pharmacovigilance regulations in line with international standards, with support from organizations such as the World Health Organization (WHO) and the Pan American Network for Drug Regulatory Harmonization.

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Hungary

NCA: The National Institute of Pharmacy and Nutrition (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet – OGYÉI)

QPPV/LQPPV/LCPPV Requirements: Qualified Person for Pharmacovigilance (QPPV): Marketing Authorization Holders (MAHs) are required to appoint a QPPV who is responsible for the establishment and maintenance of the pharmacovigilance system. If the QPPV resides in Hungary, they must:

Hold a degree in medicine, pharmacy, dentistry, or biology.
Possess knowledge of pharmacovigilance systems and the ability to operate them.
Have at least three years of professional experience in pharmacovigilance.

If the QPPV is not a medical doctor, the MAH must ensure the availability of a medical doctor, whose name and contact details must be documented in the pharmacovigilance system master file.

Local Pharmacovigilance Contact: If the QPPV does not reside in Hungary, the MAH must appoint a local pharmacovigilance contact who reports to the QPPV. This local contact must:

Hold a degree in life sciences, chemistry, or chemical engineering.
Have adequate training on reporting requirements to the QPPV, with training provided or acknowledged by the MAH.

The local contact is expected to reside in Hungary and have a thorough command of the Hungarian language to effectively manage pharmacovigilance data originating from Hungary.

Normative Documents:

Decree 15/2012 (VIII. 22.) of the Ministry of Human Resources on the Pharmacovigilance of Medicinal Products for Human Use: This decree outlines the specific requirements for pharmacovigilance activities, including the roles and qualifications of the QPPV and local pharmacovigilance contact in Hungary.
European Union Good Pharmacovigilance Practices (GVP): Hungary, as an EU member state, adheres to the EU GVP guidelines, which provide a comprehensive framework for pharmacovigilance activities across the EU.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy

Iceland

NCA: The Icelandic Medicines Agency (IMA)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) are required to have a Qualified Person for Pharmacovigilance (QPPV) who resides and operates within the European Economic Area (EEA), which includes Iceland. However, the IMA does not mandate that the QPPV be located specifically in Iceland.

Normative Documents:

Iceland adheres to European Union (EU) pharmacovigilance legislation and guidelines, including the Good Pharmacovigilance Practices (GVP) modules. Additionally, the Medicinal Products Act, No. 100/2020, governs the regulation of medicinal products in Iceland.

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India

NCA: The Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in India are required to establish a pharmacovigilance system and appoint a Qualified Person for Pharmacovigilance (QPPV). The QPPV should be a qualified and trained person responsible for continuously monitoring the safety of the pharmaceutical products marketed by the MAH. The QPPV should reside and operate in India and should be appropriately qualified with a degree in medicine, pharmacy, or a related field, along with relevant experience in pharmacovigilance.

Normative Documents:

Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version 2.0): This guidance document, published by the IPC in collaboration with CDSCO, provides detailed information on establishing a pharmacovigilance system, preparation of the Pharmacovigilance System Master File (PSMF), post-marketing surveillance, preparation and submission of Periodic Safety Update Reports (PSURs), quality management systems, audits, inspections, and submission of Risk Management Plans (RMPs).
Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines: This document, published by CDSCO, provides guidance to MAHs about vaccine safety monitoring, audits and inspections, risk management plans, and periodic submission of risk-benefit evaluation reports.

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Indonesia

NCA: The National Agency of Drug and Food Control (NADFC), known locally as Badan Pengawas Obat dan Makanan (BPOM)

QPPV/LQPPV/LCPPV Requirements: In Indonesia, pharmaceutical companies are required to establish a pharmacovigilance system to monitor the safety of their products post-marketing. While the specific designation of a Qualified Person for Pharmacovigilance (QPPV) is not explicitly mandated, companies must have dedicated personnel responsible for pharmacovigilance activities. These individuals should be adequately trained and qualified to manage adverse drug reaction (ADR) reporting, risk assessment, and communication with regulatory authorities.

Normative Documents:

Regulation of the Head of NADFC No. HK.03.1.23.12.11.10690 of 2011: This regulation outlines the implementation of pharmacovigilance for the pharmaceutical industry, detailing the responsibilities of companies in monitoring and reporting ADRs.
Technical Guidelines on Good Distribution Practices (GDP) 2012: These guidelines ensure that pharmaceutical products are consistently stored, transported, and handled under suitable conditions to maintain their quality and integrity throughout the distribution process.
Law No. 36 of 2009 on Health: This law serves as the foundation for regulating health services, including pharmaceuticals, in Indonesia. It outlines the government’s responsibilities to ensure public health and covers various aspects such as ensuring the availability and affordability of safe, effective, and high-quality drugs.

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Iran

NCA: The Iranian Food and Drug Administration (IFDA) under the Ministry of Health and Medical Education

QPPV/LQPPV/LCPPV Requirements: Appoint of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV) are recommended. The IFDA mandates pharmaceutical companies establish a robust pharmacovigilance system to monitor and report adverse drug reactions (ADRs) and ensure the safety of medicinal products.

Normative Documents:

IFDA aligns its regulatory framework with international standards to ensure the quality, safety, and efficacy of medications. The Pharmaceutical Law of Iran, enacted in 1983, governs the pharmaceutical market, establishing the framework for the registration, manufacturing, and distribution of medications.

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Iraq

NCA: The Iraqi Pharmacovigilance Center (IPhvC) under the Ministry of Health’s Directorate of Technical Affairs

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Iraq are required to appoint a Qualified Person for Pharmacovigilance (QPPV) or a Local Safety Responsible (LSR). The appointed individual should possess appropriate qualifications and experience in pharmacovigilance. The IPhvC accepts the delegation of all pharmacovigilance activities to a third party representing the MAH.

Normative Documents:

Iraq has developed specific guidelines to support its pharmacovigilance system:

Good Pharmacovigilance Practice Guideline for Pharmaceutical Companies, Marketing Authorization Holders, and their Representatives in Iraq (Version 2.0, 2021): This guideline provides comprehensive instructions on establishing and maintaining pharmacovigilance systems, including the roles and responsibilities of QPPVs/LSRs, reporting requirements, and risk management plans.
Guidelines for the Iraqi Pharmacovigilance System (IPhvC): These guidelines offer an overview of pharmacovigilance operations in Iraq, detailing the detection and classification of ADRs and the structural organization of the system.

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Ireland

NCA: The Health Products Regulatory Authority (HPRA)

QPPV/LQPPV/LCPPV Requirements:

In the European Union (EU), including Ireland, Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV must reside and operate within the EU/European Economic Area (EEA) and is responsible for establishing and maintaining the MAH’s pharmacovigilance system. The QPPV’s key responsibilities include:

Overseeing the safety profiles of the company’s medicinal products.
Acting as a single contact point for the Health Authorities on a 24-hour basis.

While the EU legislation mandates the appointment of a QPPV, some EU member states may also require a Local Contact Person for Pharmacovigilance (LCPPV). As of the current information, Ireland does not mandate the appointment of an LCPPV in addition to the EU QPPV.

Normative Documents:

The pharmacovigilance framework in Ireland is governed by EU legislation and guidelines, including:

Regulation (EC) No 726/2004: Establishes procedures for the authorization and supervision of medicinal products for human and veterinary use and the role of the European Medicines Agency (EMA).
Directive 2001/83/EC: Relates to the Community code concerning medicinal products for human use.
Good Pharmacovigilance Practices (GVP): A set of measures drawn up to facilitate the performance of pharmacovigilance in the EU, providing detailed guidelines on the roles and responsibilities of the QPPV.

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Israel

NCA: The Pharmacovigilance and Drug Information Department under the Israeli Ministry of Health (MOH)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV must be a licensed pharmacist with a minimum of two years of experience and is responsible for all pharmacovigilance activities. QPPV must be local company employee.

Normative Documents:

Pharmacists’ Regulations (Preparations) 1986: This regulation obliges every registration holder to promptly notify the Ministry of Health, via the appointed pharmacist, regarding any new information concerning their drugs.
Medical Device Law (2012): Part C – Article 11 of this law sets similar requirements for medical device companies, mandating the reporting of new safety information to the Ministry of Health.

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Italy (Inc.Vatican)

NCA: The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who resides and operates within the European Union (EU). The QPPV is responsible for establishing and maintaining the MAH’s pharmacovigilance system and serves as the primary contact point for pharmacovigilance matters.

If the QPPV does not speak or write Italian, MAH must appoint a national contact person for pharmacovigilance. This requirement ensures that all communications with AIFA are conducted in Italian. The appointed local contact person must be registered on the AIFA portal.

Normative Documents:

Directive 2010/84/EU: This directive amends previous legislation to enhance pharmacovigilance for medicinal products for human use.
Regulation (EU) No. 520/2012: This regulation lays down the provisions concerning the performance of pharmacovigilance activities.
Decree 30 April 2015, Article 17: This national decree outlines specific requirements for pharmacovigilance practices in Italy, including the roles and responsibilities of the QPPV.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Jamaica, Japan, Jordan

Jamaica

NCA: The Standards and Regulation Division (SRD) under the Ministry of Health & Wellness (MoHW)

QPPV/LQPPV/LCPPV Requirements: Jamaica does not currently mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a local contact person for pharmacovigilance (LCPPV). However, Marketing Authorization Holders (MAHs) are required to report any unexpected side effects, injuries, toxicities, or sensitivity reactions associated with their products to the Minister of Health. This requirement is stipulated in the Food and Drugs Act, Regulation 70, 1975.

Normative Documents:

Food and Drugs Act, Regulation 70, 1975: This regulation mandates that any person receiving reports of unexpected side effects, injuries, toxicities, or sensitivity reactions associated with clinical uses, studies, investigations, and tests of any new drug must immediately inform the Minister of Health, providing full information available.
PharmWatch Drug Monitoring Reporting Forms: Local adverse drug reactions (ADRs) are submitted to the NPvC using these forms, facilitating the collection and assessment of ADRs.

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Japan

NCA: The Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare (MHLW)

QPPV/LQPPV/LCPPV Requirements: In Japan, Marketing Authorization Holders (MAHs) are required to appoint a General Marketing Compliance Officer (GCO), who is responsible for ensuring compliance with Good Vigilance Practice (GVP) and Good Quality Practice (GQP) standards. While the role of a Qualified Person for Pharmacovigilance (QPPV) is recognized internationally, Japan’s regulatory framework emphasizes the responsibilities of the GCO in overseeing pharmacovigilance activities. The GCO must have a thorough understanding of GVP and other associated pharmaceutical regulations in Japan.

Normative Documents:

Good Vigilance Practice (GVP) Ordinance: This ordinance outlines the standards for post-marketing safety management of drugs, quasi-drugs, cosmetics, and medical devices in Japan. It specifies the responsibilities of MAHs, including the establishment of a safety management system and the appointment of a GCO.
Risk Management Plan (RMP) Guidance: The MHLW has issued guidance on the preparation and implementation of RMPs, which are essential for identifying, evaluating, and minimizing risks associated with pharmaceutical products. The RMP serves as a communication tool between regulatory authorities and MAHs, starting from the New Drug Application (NDA) submission.

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Jordan

NCA: The Jordan Food and Drug Administration (JFDA)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Jordan are required to appoint a Qualified Person for Pharmacovigilance (QPPV) who resides within the country. The QPPV is responsible for overseeing the company’s pharmacovigilance activities, ensuring compliance with local regulations, and serving as the primary contact point for the JFDA on safety-related matters. This requirement aligns with the Arab Good Pharmacovigilance Practices (GVP) guidelines, which Jordan has adopted.

Normative Documents:

Guideline on Good Pharmacovigilance Practices (GVP): This guideline outlines the obligations of MAHs to establish a pharmacovigilance system for collecting, collating, and evaluating information about suspected adverse reactions. It emphasizes the importance of sharing all relevant information with the medicines authority.
Guidelines for Detecting & Reporting Adverse Drug Reactions in Jordan: Developed to orient healthcare professionals on pharmacovigilance, this document provides an overview of detecting and classifying adverse drug reactions (ADRs) and describes the reporting system to the Jordan Pharmacovigilance Centre.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «K» (Kazakhstan, Kenya,..)

Сomplete list of countries: Kazakhstan, Kenya, Kiribati, Korea (North), Korea (South), Kosovo, Kuwait, Kyrgyzstan.

Kazakhstan

NCA: National Center for Expertise of Medicines and Medical Devices (NCEM) under the Ministry of Healthcare of the Republic of Kazakhstan

QPPV/LQPPV/LCPPV Requirements:

While not termed “QPPV” as in the EU, Kazakhstan requires a local responsible person for pharmacovigilance (often a pharmacist or physician).
This PV local contact must be based in Kazakhstan, handle adverse event reporting, maintain pharmacovigilance documentation, and liaise with NCEM/Ministry of Healthcare.
Implementation of EAEU Good Pharmacovigilance Practices (GVP) is ongoing, further defining the local PV contact’s responsibilities and reporting timelines.

Normative Documents:

Law on Circulation of Medicines and Medical Devices – Core legislative act governing pharmaceuticals.
Ministerial Orders/Decrees – Detailing registration procedures, PV obligations, and reporting timelines.
EAEU Regulations – Provide harmonized guidelines for pharmacovigilance and marketing authorization across member states.
NCEM Guidelines – Local technical guidance on dossier submission, safety reporting, and risk management.

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Kenya

NCA: Pharmacy and Poisons Board (PPB) under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Local PV Contact or Local QPPV is typically required.
Must be a Kenyan resident and generally a licensed pharmacist or physician registered with the relevant professional council.
Responsible for adverse event reporting, risk management, and liaison with the PPB.

Normative Documents:

Pharmacy and Poisons Act (Cap 244) – primary legislation governing pharmaceuticals.
PPB Guidelines – detail requirements for drug registration, pharmacovigilance reporting formats, and timelines.
East African Community (EAC) Harmonization Guidelines – regional standards that may influence local regulatory processes.

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Kiribati

NCA: The Ministry of Health and Medical Services (MHMS)

QPPV/LQPPV/LCPPV Requirements:

No formal QPPV or EU-style pharmacovigilance mandate.
Adverse event reporting systems are minimal, handled on an ad-hoc basis through the MHMS.
A local contact person (pharmacist or healthcare provider) might be informally required for product import or distribution, but official guidelines are limited.

Normative Documents:

Public Health Legislation/Regulations – Any existing act or regulations under the MHMS addressing medicines control, though these can be fragmented or outdated.
Regional/WHO Guidance – Kiribati often follows WHO recommendations or regional Pacific guidelines for essential medicines and pharmacovigilance best practices.
Ad-hoc Ministry Circulars – Local policy directives may be issued as needed, especially regarding import permits or drug safety alerts.

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Korea, North

NCA: National Medicines Regulatory Authority the Ministry of Public Health

QPPV/LQPPV/LCPPV Requirements:

There is no publicly available information indicating the existence of an EU-style QPPV (Qualified Person for Pharmacovigilance) requirement.
Pharmacovigilance activities, if any, are presumed to be managed through internal government channels. Reporting and monitoring protocols are not disclosed to international organizations in detail.

Normative Documents:

Public Health Laws / Decrees – North Korea may have internal legislation covering pharmaceutical regulation, but texts are not routinely released internationally.
Ministry of Public Health Directives – Regulations or guidelines could be issued internally by the Ministry; publicly accessible versions are scarce.
Ad-Hoc State Guidance – The DPRK government often issues guidelines centrally, but details remain largely undisclosed.
WHO Involvement – North Korea has engaged with WHO on specific health initiatives, but direct references to national PV guidelines or regulatory frameworks are minimal.

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Korea, South

NCA: Ministry of Food and Drug Safety (MFDS) (formerly KFDA) under the Ministry of Health and Welfare.

QPPV/LQPPV/LCPPV Requirements:

While not termed “QPPV” as in the EU, local PV obligations are well-defined.
A Responsible Person for Pharmacovigilance (RPPV) must be appointed by the Marketing Authorization Holder (MAH).
The RPPV is typically a pharmacist or healthcare professional based in South Korea, responsible for adverse event reporting, safety monitoring, and liaising with MFDS.

Normative Documents:

Pharmaceutical Affairs Act – Core legislation governing pharmaceutical products.
MFDS Pharmacovigilance Regulations – Detailed rules on AE reporting timelines, risk management, and safety updates.
MFDS Guidelines / Notifications – Provide practical instructions and templates for local PV compliance.
International Harmonization – South Korea often aligns with ICH guidelines (e.g., E2 series for safety reporting).

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Kosovo

NCA: Kosovo Medicines Agency (KMA) under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Local PV Contact is typically required for Marketing Authorization Holders.
Often a pharmacist or physician licensed in Kosovo, responsible for adverse event reporting and liaising with the KMA.
No strict “EU QPPV” framework, but local PV obligations are increasingly aligned with EU best practices.

Normative Documents:

Law on Medicinal Products and Medical Devices – primary legislation establishing regulatory requirements.
Administrative Instructions / KMA Guidelines – detail processes for product registration, safety reporting, and compliance.
Official Gazette of the Republic of Kosovo – publishes enacted laws, decrees, and any subsequent amendments.

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Kuwait

NCA: Drug and Food Control within the Ministry of Health (MoH)

QPPV/LQPPV/LCPPV Requirements:

A local PV contact (often a licensed pharmacist) is typically required for Marketing Authorization Holders (MAHs).
Responsible for adverse event reporting, risk management activities, and formal communication with the MoH.
Must be based in Kuwait and coordinate closely with the global PV system of the MAH (if applicable).

Normative Documents:

Kuwait Ministry of Health Regulations/Decrees – primary legal instruments covering drug registration and pharmacovigilance.
GCC (Gulf Cooperation Council) Guidelines – regional standards that often inform registration requirements and safety reporting procedures.
Internal MoH Circulars – detail updates on PV reporting timelines and other compliance obligations.

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Kyrgyzstan

NCA: Department of Medicines Provision and Medical Equipment under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Local PV Contact: A locally based representative (pharmacist or physician) is generally required for pharmaceutical companies.
Responsible for adverse event reporting, coordinating with the Department of Medicines Provision, and ensuring compliance with both national and EAEU GVP guidelines.

Normative Documents:

Law on Medicines Circulation – Core national legislation governing pharmaceuticals.
Ministry of Health Orders/Decrees – Detailed instructions on product registration, PV reporting, and risk management.
EAEU Regulations – Kyrgyzstan aligns with Eurasian Economic Union Good Pharmacovigilance Practices and drug registration procedures.
Official Government Publications – The Kyrgyz Gazette (Жогорку Кеңеш) and Ministry websites provide updates or amendments.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «L» (Laos, Latvia,..)

Сomplete list of countries: Laos, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg.

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Laos

NCA: Food and Drug Department (FDD) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

No formal QPPV system as in the EU. However, a local contact person (often a pharmacist or medical professional) is generally required for product registrations.
This local representative coordinates adverse event reporting, submits safety data to the FDD, and ensures compliance with local guidelines.

Normative Documents:

Law on Drugs and Medical Products (updated versions/editions outline the legal basis for regulation).
FDD Guidelines – Provide procedures for drug registration, post-marketing surveillance, and pharmacovigilance reporting.
ASEAN Harmonized Requirements – Laos, as an ASEAN member, often refers to ASEAN guidelines for drug evaluation and PV standards.
Ministerial Decrees / Regulations – Issued periodically to clarify import procedures, licensing obligations, and reporting deadlines.

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Latvia

NCA: State Agency of Medicines (Zāļu valsts aģentūra, ZVA) under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

As an EU Member State, Latvia follows EU pharmacovigilance laws.
Qualified Person for Pharmacovigilance (QPPV): Must be located within the EU/EEA.
Local Contact: A Latvian-speaking PV contact is often required for direct interaction with ZVA and to ensure compliance with local language requirements for safety reporting.
Responsible for adverse event reporting, risk management, and maintaining the Pharmacovigilance System Master File (PSMF) in line with EU Good Pharmacovigilance Practices (GVP).

Normative Documents:

Pharmaceutical Law (Farmācijas likums) – the main national legislative act, transposing EU Directives (e.g., Directive 2001/83/EC).
EU Regulations & Directives – Notably Regulation (EC) No 726/2004 and other EU PV legislation, directly applicable in Latvia.
ZVA Guidelines & Announcements – Latvia-specific instructions for submission processes, safety reporting timelines, and compliance

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Lebanon

NCA: Ministry of Public Health (MoPH)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV framework.
Typically, a local representative (often a licensed pharmacist) is required for product registration and post-marketing surveillance.
Responsible for adverse event reporting and liaising with the MoPH on safety matters.

Normative Documents:

Pharmacy Law and Decrees – The foundational legal framework governing pharmaceuticals (e.g., Law 367 and subsequent decrees).
Ministerial Decisions / Circulars – Provide practical instructions on registration processes, labeling, and post-marketing requirements, including pharmacovigilance obligations.

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Lesotho

NCA: The Directorate of Pharmacy Services Ministry of Health (MoH)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system.
In practice, a local contact person (often a pharmacist) may be required for import permits, product registration, and handling any safety issues.
Formal pharmacovigilance infrastructure is limited; serious adverse event reports are typically managed through the MoH on a case-by-case basis.

Normative Documents:

Pharmacy Act or related legislation under the Ministry of Health, covering aspects of pharmacy practice and drug distribution.
Ministerial Circulars / Directives – Ad hoc guidelines issued by the MoH on licensing, import regulations, and any emergent pharmacovigilance procedures.
SADC / WHO Guidelines – Lesotho is a member of the Southern African Development Community, which may influence harmonized drug registration and safety reporting standards.

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Liberia

NCA: Liberia Medicines and Health Products Regulatory Authority (LMHRA) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system.
Marketing Authorization Holders typically need a local representative (often a pharmacist or healthcare professional) registered in Liberia.
Handles adverse event reporting, liaises with LMHRA on safety concerns, and ensures local compliance.

Normative Documents:

LMHRA Act – Establishes the authority and its mandate over medicinal products.
LMHRA Guidelines/Regulations – Outline drug registration procedures, post-marketing surveillance, and AE reporting.
Public Health Law – Broader legal framework influencing pharmaceutical regulation.
ECOWAS/WAHO Directives – Liberia may align with West African harmonization efforts for drug registration and pharmacovigilance.

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Libya

NCA: The Drug and Food Control Center (DFCC) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system is currently in place.
A local representative (often a pharmacist or healthcare professional) is typically required for product registration and basic safety reporting.
Adverse event reporting infrastructure is limited; serious safety concerns are typically addressed case-by-case by the DFCC or Ministry of Health.

Normative Documents:

Pharmacy / Medicines Legislation – Older national laws and decrees, potentially amended by post-2011 regulations.
Ministerial Circulars / Directives – Ad hoc guidelines from the Ministry of Health or DFCC outlining import permits, distribution controls, and basic PV obligations.

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Liechtenstein

NCA: The Liechtenstein Office of Public Health (Amt für Gesundheit) and Swissmedic (the Swiss Agency for Therapeutic Products)

QPPV/LQPPV/LCPPV Requirements:

As part of the European Economic Area (EEA), Liechtenstein is subject to EU/EEA pharmacovigilance rules.
Qualified Person for Pharmacovigilance (QPPV): Must be based in an EU/EEA country (which includes Liechtenstein).
Typically, no separate local QPPV beyond the EU/EEA QPPV is required; however, some companies designate a local contact person in Liechtenstein or Switzerland to liaise with Swissmedic and local authorities.
Responsibilities include ensuring adverse event reporting, maintaining a Pharmacovigilance System Master File (PSMF), and following EU Good Pharmacovigilance Practices (GVP).

Normative Documents:

Swiss Therapeutic Products Legislation – Primarily applied via the Swiss–Liechtenstein agreement (Therapeutic Products Act and associated ordinances).
EEA/EU Pharmaceutical Legislation – Liechtenstein is an EEA member and must follow EU directives/regulations (e.g., Directive 2001/83/EC, Regulation (EC) No 726/2004).
Swissmedic Guidelines – Relevant for marketing authorization procedures, safety reporting, and risk management plans in Liechtenstein.

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Lithuania

NCA: State Medicines Control Agency (Valstybinė vaistų kontrolės tarnyba, VVKT) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

As an EU Member State, Lithuania adheres to EU pharmacovigilance rules.
A Qualified Person for Pharmacovigilance (QPPV) is required; the QPPV must reside in the EU/EEA.
A local contact in Lithuania (often a pharmacist or physician fluent in Lithuanian) is typically appointed to handle adverse event reporting and liaise with VVKT.
Responsibilities include maintaining the Pharmacovigilance System Master File (PSMF) and ensuring compliance with EU Good Pharmacovigilance Practices (GVP).

Normative Documents:

Lithuanian Law on Pharmacy (Vaistų įstatymas) – Implements EU pharmaceutical directives (e.g., Directive 2001/83/EC).
EU Regulations & Directives – Notably Regulation (EC) No 726/2004, applying to EU-wide authorization procedures and pharmacovigilance obligations.
VVKT Guidelines – Country-specific instructions on registration processes, reporting formats, and PV timelines.

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Luxembourg

NCA: The Directorate of Health under the Ministry of Health (Ministère de la Santé)

QPPV/LQPPV/LCPPV Requirements:

As an EU Member State, Luxembourg follows EU pharmacovigilance legislation.
A Qualified Person for Pharmacovigilance (QPPV) is required; the QPPV must be based in the EU/EEA.
A local contact in Luxembourg, often a pharmacist or physician fluent in French/German (and sometimes Luxembourgish), typically interfaces with the Ministry of Health for adverse event (AE) reporting and safety updates.
Responsibilities include maintaining a Pharmacovigilance System Master File (PSMF) and ensuring compliance with EU Good Pharmacovigilance Practices (GVP).

Normative Documents:

Grand-Ducal Regulations & National Drug Legislation – Transposing EU Directives (e.g., Directive 2001/83/EC) into Luxembourg law.
EU Regulations & Guidelines – Such as Regulation (EC) No 726/2004 and GVP modules, directly applicable in Luxembourg.
Ministry of Health Circulars – Providing country-specific instructions on submission processes and PV requirements.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «M» (Madagascar, Malawi,..)

Сomplete list of countries: Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Mexico, Micronesia Federated States (FSD), Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Myanmar (Burma).

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Madagascar

NCA: The Madagascar Drug Agency (AGMED) under the Ministry of Public Health

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources.

Normative Documents:

Medicines Registration Procedure Manual (2016): Outlines the procedures for registering medicinal products in Madagascar, including the required documentation and evaluation process.
National Pharmacovigilance Policy (2011): Establishes the framework for monitoring and reporting adverse drug reactions to ensure patient safety.
Good Manufacturing Practices (GMP) Guidelines: While not yet formally considered in the regulations, there are efforts to incorporate GMP standards for manufacturers.

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Malawi

NCA: The Pharmacy and Medicines Regulatory Authority (PMRA)

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources.

Normative Documents:

Pharmacy and Medicines Regulatory Authority Act No. 9 of 2019: Establishes the legal basis for the regulation of medicines, allied substances, and the pharmacy profession in Malawi.
Pharmacy, Medicines and Poisons Act (1988): Provides provisions for the registration and regulation of pharmacists, pharmacy technologists, pharmacy assistants, and medical representatives, as well as the registration of premises and licensing related to pharmaceutical activities.
Guidelines on Registration and Licensing of Medicinal Products in Malawi: Offers guidance for applicants on the procedures and requirements for registering and licensing medicinal products in the country.
PMRA Guidelines: A collection of guidelines provided by the PMRA to assist stakeholders in complying with regulatory requirements.

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Malaysia

NCA: The National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

In Malaysia, Marketing Authorization Holders (MAHs) are required to establish a pharmacovigilance system to monitor the safety of their products. While the specific designation of a QPPV is not explicitly mandated, MAHs must ensure that competent personnel are responsible for pharmacovigilance activities, including the collection, evaluation, and reporting of adverse drug reactions.

Normative Documents:

Drug Registration Guidance Document (DRGD): Provides comprehensive guidelines on the registration process for pharmaceutical products, including requirements for quality, safety, and efficacy.
Guideline on Regulatory Control of Active Pharmaceutical Ingredients (APIs): Outlines the procedures and requirements for the control of APIs in product registration applications.
Good Manufacturing Practice (GMP) Guidelines: Establish standards for the manufacturing processes to ensure product quality and safety.
Good Clinical Practice (GCP) Guidelines: Provide standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials.

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Maldives

NCA: The Maldives Food and Drug Authority (MFDA) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

In the Maldives, Marketing Authorization Holders (MAHs) are required to establish a pharmacovigilance system to monitor the safety of their products. While the specific designation of a QPPV is not explicitly mandated, MAHs must ensure that competent personnel are responsible for pharmacovigilance activities, including the collection, evaluation, and reporting of adverse drug reactions. This is outlined in the Guideline on Pharmacovigilance and ADR Reporting issued by the MFDA.

Normative Documents:

Medicine Regulation No: R-46/2014: Implemented on 20th January 2015, this regulation mandates that medicines manufactured, sold, and imported into the Maldives must be registered with the MFDA.
Guideline on Pharmacovigilance and ADR Reporting: Provides detailed procedures for monitoring and reporting adverse drug reactions to ensure patient safety.
Guideline on Pharmaceutical Inspection: Outlines the standards and procedures for inspecting pharmaceutical establishments to ensure compliance with regulatory requirements.

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Mali

NCA: The Direction de la Pharmacie et du Médicament (DPM) under the Ministry of Health and Social Development

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources.

Normative Documents:

Law No. 09-059 (2009): Establishes the legal basis for the regulation of medicinal products in Mali, including provisions for clinical trials and pharmacovigilance.
Decree No. 2011-753/P-RM (2011): Outlines the organization and functioning of the DPM, detailing its roles and responsibilities in medicine regulation.
Order No. 2011-4201/MS-SG (2011): Sets the methods for implementing pharmacovigilance, detailing the responsibilities of the DPM and CNAM in monitoring drug safety.

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Malta

NCA: The Malta Medicines Authority under the Ministry for Health

QPPV/LQPPV/LCPPV Requirements:

In accordance with the Pharmacovigilance Regulations 2012 (S.L.458.35), a Marketing Authorisation Holder (MAH) must have permanently and continuously at their disposal an appropriately qualified person responsible for pharmacovigilance (QPPV). The QPPV is responsible for establishing and maintaining the pharmacovigilance system and ensuring compliance with legal requirements.

Normative Documents:

Medicines Act 2003: Establishes the legal basis for the regulation of medicinal products in Malta.
Pharmacovigilance Regulations 2012 (S.L.458.35): Outlines the requirements for pharmacovigilance activities, including the roles and responsibilities of the QPPV.
Good Pharmacovigilance Practice (GVP) Guidelines: Provide detailed guidance on the conduct of pharmacovigilance activities to ensure the safety of medicinal products.

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Marshall Islands

NCA: The Ministry of Health and Human Services (MHHS)

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV are not explicitly detailed in the available sources for the Marshall Islands.

Normative Documents:

The MHHS manages health policies and regulatory frameworks aligned with international standards to ensure the safety and efficacy of medications.

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Mauritania

NCA: The Directorate of Pharmacy and Laboratories, operating under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Specific roles such as QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources.

Normative Documents:

Medicine Registration Guidelines
Clinical Trial Regulations
Import Control Regulations.

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Mauritius

NCA: The Pharmacy Board and Pharmacy Council of Mauritius under the Ministry of Health and Wellness

QPPV/LQPPV/LCPPV Requirements: N/A

Normative Documents:

Pharmacy Act 1983: Provides the legal basis for the regulation of pharmaceutical products and the practice of pharmacy in Mauritius.
Pharmacy Council Act 2015: Establishes the Pharmacy Council and outlines its functions, including the regulation of pharmacists.
Pharmacy Council (Code of Practice) Regulations 2021: Sets out the code of practice for pharmacists, including responsibilities related to pharmacovigilance and reporting of ADRs.
Clinical Trials Act 2011: Regulates the conduct of clinical trials in Mauritius, ensuring compliance with ethical standards and the safety of participants.

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Mexico

NCA: The Federal Commission for Protection against Sanitary Risks (COFEPRIS) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Specific designation of a QPPV/LQPPV/LCPPV is not explicitly mandated.

Normative Documents:

General Health Law (Ley General de Salud): Establishes the legal basis for the regulation of health-related products and services in Mexico.
Health Supplies Regulation (Reglamento de Insumos para la Salud): Provides detailed provisions for the control and oversight of health supplies, including medicines and medical devices.
Official Mexican Norms (Normas Oficiales Mexicanas – NOMs): Set specific standards and guidelines for various aspects of health product regulation, such as labeling, manufacturing practices, and pharmacovigilance.
Mexican Pharmacopoeia (Farmacopea de los Estados Unidos Mexicanos): Serves as the official compendium of drug standards, including specifications for the quality, purity, and strength of medicines.

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Micronesia

NCA: The Federated States of Micronesia (FSM)

QPPV/LQPPV/LCPPV Requirements:

Specific designation of a QPPV/LQPPV/LCPPV is not explicitly mandated.

Normative Documents:

FSM Safe Pharmaceutical Act of 2022: This Act, codified in Title 41 of the FSM Code, Chapter 13, provides the legal framework for pharmaceutical regulation in FSM. It outlines the establishment of the Pharmaceutical Unit, criteria for the FSM Approved Medicines List, licensure processes, and product registration procedures.
FSM Pharmaceutical Import Control Act of 2022: This Act, codified in Title 54 of the FSM Code, Chapter 10, regulates the importation of pharmaceutical products into FSM, ensuring that only approved and safe medicines enter the country.

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Moldova

NCA: The Agency of Medicines and Medical Devices (AMDM) under the Government of the Republic of Moldova

QPPV/LQPPV/LCPPV Requirements:

Specific designation of a QPPV/LQPPV/LCPPV is not explicitly mandated.

Normative Documents:

Law on Pharmaceutical Activity (1993)
Law on Pharmaceuticals (1997)
Regulations on Marketing Authorization of Medicinal Products for Human Use.

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Monaco

NCA: The Direction de l’Action Sanitaire (DAS) under the Ministry of Health and Social Affairs

QPPV/LQPPV/LCPPV Requirements:

Specific designation of a QPPV/LQPPV/LCPPV is not explicitly mandated.

Normative Documents:

Ordonnance Souveraine (Sovereign Order): Establishes the fundamental laws applicable to the manufacturing, distribution, and sale of medicinal products in Monaco.
Arrêté Ministériel n° 2003-163 du 3 mars 2003: Outlines the procedures for pharmacovigilance and the monitoring of drug dependence concerning human medicines and non-medicinal substances.

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Mongolia

NCA: The Medicine and Medical Devices Regulatory Authority (MMRA) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

In Mongolia, applicants (manufacturers) are not required to appoint an authorized person responsible for pharmacovigilance within the territory.

Normative Documents:

Law on Medicines and Medical Devices (1998)
Order No. 415 (2013)
Order No. 13 (2015).

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Montenegro

NCA: The Institute for Medicines and Medical Devices (CInMED)

QPPV/LQPPV/LCPPV Requirements:

Appointment of QPPV is required. QPPV must reside within Montenegro and possess the necessary qualifications and experience to fulfill these responsibilities.

Normative Documents:

Law on Medicines (“Official Gazette of Montenegro”, No. 80/20): Establishes the legal basis for the regulation of medicinal products, including provisions for pharmacovigilance, manufacturing, distribution, and marketing authorization.
Law on Medical Devices (2019): Sets out the general principles related to the manufacturing, distribution, and supervision of medical devices in Montenegro.
Good Pharmacovigilance Practices (GVP) Guidelines: Provide detailed procedures and requirements for the monitoring of medicinal product safety, aligning with European Union standards.

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Morocco

NCA: The Directorate of Medicines and Pharmacy (DMP) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Specific designation of a QPPV/LQPPV/LCPPV is not explicitly mandated.

Normative Documents:

Law No. 17-04: Establishes the legal basis for the regulation of pharmaceutical activities in Morocco, including licensing requirements for the production, importing, and registration of drugs.
Good Pharmacovigilance Practices (GVP) Guidelines: Provide detailed guidelines on the establishment and maintenance of pharmacovigilance systems, the role of responsible personnel, and the procedures for reporting adverse drug reactions.
Moroccan Good Regulatory Practices: Outline the regulatory and technical requirements for the registration of medicines for human use in Morocco, ensuring that all products meet established safety and efficacy standards.

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Mozambique

NCA: The Autoridade Nacional Reguladora de Medicamentos, Instituto Público (ANARME, IP) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Specific designation of a QPPV/LQPPV/LCPPV is not explicitly mandated.

Normative Documents:

Medicines Act (2017): Provides a solid legal framework for the regulation of medicines, vaccines, and biological products in Mozambique.
Regulations of the National Pharmacovigilance System: Outlines the procedures for monitoring the safety of medicines, including the responsibilities of healthcare professionals and MAHs in reporting adverse drug reactions.
Good Manufacturing Practices (GMP) Guidelines: Establishes the standards for the production of pharmaceutical products to ensure their quality and safety.

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Myanmar (Burma)

NCA: The Myanmar Food and Drug Administration (MFDA) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Specific designation of a QPPV/LQPPV/LCPPV is not explicitly mandated.

Normative Documents:

National Drug Law (1992): Establishes the legal basis for the regulation of pharmaceutical activities in Myanmar, including the manufacture, import, export, storage, distribution, and sale of drugs.
Guideline on Drug Registration Application (2014): Outlines the procedures and requirements for the registration of pharmaceutical products in Myanmar.
Regulations of the National Pharmacovigilance System: Provide guidelines for monitoring the safety of medicines, including the responsibilities of healthcare professionals and the MFDA in reporting and managing ADRs.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «N» (Namibia, Nauru,..)

Сomplete list of countries: Namibia, Nauru, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, North Macedonia, Norway.

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Namibia

NCA: Namibia Medicines Regulatory Council (NMRC) under the Ministry of Health and Social Services (MoHSS)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV framework.
A local representative (often a pharmacist or qualified healthcare professional) is generally required for product registration and post-marketing safety tasks.
Handles adverse event reporting and liaises with NMRC on safety concerns and compliance obligations.

Normative Documents:

Medicines and Related Substances Control Act (Act No. 13 of 2003) – Core legislation governing the registration, control, and sale of medicines.
Regulations and Guidelines issued by the NMRC – Detail procedures for product registration, import permits, and pharmacovigilance requirements.

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Nauru

NCA: The Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system in place.
A local contact person (often a pharmacist or healthcare worker) may informally handle any adverse event reporting or import logistics.
Pharmacovigilance structures are minimal; serious issues are typically handled on a case-by-case basis through the Ministry of Health.

Normative Documents:

Public Health or Pharmacy Act – Any existing national legislation (limited and not widely published).
Ministry Circulars / Notices – Ad hoc directives regulating medicine imports and distribution.
Regional/WHO Guidance – Nauru often relies on WHO recommendations or regional Pacific guidelines for essential medicines and safety surveillance.

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Nepal

NCA: Department of Drug Administration (DDA) under the Ministry of Health and Population

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV framework.
A local representative (often a pharmacist or physician registered in Nepal) is typically required for product registrations and basic safety reporting.
Responsible for adverse event reporting to the DDA and for maintaining compliance with local PV guidelines.

Normative Documents:

Drug Act, 1978 – Foundational legislation for pharmaceutical regulation in Nepal.
Drug Advisory Committee Guidelines & DDA Circulars – Outline registration processes, reporting requirements, and PV obligations.
National Pharmacovigilance Guidelines – Provide a framework for adverse event monitoring, data collection, and assessment in Nepal.
WHO References – Nepal often aligns with WHO recommendations, particularly for essential medicines and pharmacovigilance standards.

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Netherlands

NCA: Medicines Evaluation Board (MEB / CBG) and Health and Youth Care Inspectorate (IGJ), both operate under the Ministry of Health, Welfare and Sport

QPPV/LQPPV/LCPPV Requirements:

As an EU Member State, the Netherlands follows EU pharmacovigilance legislation.
A Qualified Person for Pharmacovigilance (QPPV) based in the EU/EEA is mandatory.
Local Contact: Commonly, a Dutch-speaking contact or agent is designated to liaise with the MEB/IGJ regarding pharmacovigilance and adverse event reports.
Responsibilities include maintaining a Pharmacovigilance System Master File (PSMF), fulfilling Good Pharmacovigilance Practices (GVP), and ensuring timely safety reporting.

Normative Documents:

Medicines Act (Geneesmiddelenwet) – Primary Dutch law regulating medicinal products, transposing EU Directives (e.g., Directive 2001/83/EC).
EU Regulations & Directives – Including Regulation (EC) No 726/2004 and GVP Modules, directly applicable or embedded in Dutch law.
MEB/CBG Guidelines – Additional instructions on registration procedures, PV obligations, and reporting timelines.

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New Zealand

NCA: Centre for Adverse Reactions Monitoring (CARM) and Medsafe under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

No formal “QPPV” system like in the EU.
The Sponsor (local entity or representative) holds legal responsibility for the product in New Zealand.
The Sponsor must ensure adverse event reporting to Medsafe/CARM, maintain a suitable pharmacovigilance system, and handle safety communication locally.
A local contact person (usually a pharmacist or regulatory specialist) is typically required for post-marketing surveillance and regulatory liaison.

Normative Documents:

Medicines Act 1981 and Medicines Regulations 1984 – Core legislation for approval, classification, and handling of medicines.
Medsafe Guidelines – Details on product registration (New Medicine Applications), post-approval obligations, and PV requirements.
New Zealand Datasheet and Labeling Requirements – Outline local labeling standards and product information guidelines.
Medsafe Safety Information – Periodic advisories, recall notices, and updates published on the Medsafe website.

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Nicaragua

NCA: Dirección de Farmacias y Drogas under the Ministerio de Salud (MINSA)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV framework.
A local representative (usually a pharmacist or healthcare professional) is required for product registration.
Responsible for adverse event reporting, post-marketing safety monitoring, and liaison with MINSA.

Normative Documents:

Ley General de Salud – Foundational health legislation outlining the roles and responsibilities of MINSA.
Reglamentos / Decretos from MINSA – Specify procedures for drug registration, pharmacovigilance obligations, and reporting timelines..
MINSA Circulars / Guidelines – Provide practical instructions regarding pharmacovigilance reporting and compliance.

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Niger

NCA: Direction de la Pharmacie et de la Médecine Traditionnelle (DPM / DPH) under the Ministry of Public Health

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system in place.
Marketing Authorization Holders typically appoint a local contact (often a pharmacist) for adverse event reporting and liaison with the DPM.
Pharmacovigilance infrastructure is modest; serious safety concerns are communicated to the DPM on a case-by-case basis.

Normative Documents:

Pharmaceutical Law / Ordonnances – Establish the legal framework for drug registration, distribution, and PV obligations.
Ministerial Decrees / Arrêtés – Provide procedural details for product registration and safety reporting.
ECOWAS / WAHO Directives – Niger, as part of West Africa, may align with regional harmonization efforts on pharmacovigilance and drug regulation.

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Nigeria

NCA: National Agency for Food and Drug Administration and Control (NAFDAC) under the Federal Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Local Pharmacovigilance Contact (often a pharmacist) is mandatory for Marketing Authorization Holders (MAHs).
Must be based in Nigeria and registered with relevant professional bodies (e.g., Pharmacists Council of Nigeria).
Responsibilities include adverse event (AE) reporting, coordination with NAFDAC on product safety, and ensuring compliance with local pharmacovigilance guidelines.
Serious AEs typically must be reported within 15 days, while other safety updates follow NAFDAC-defined timelines.

Normative Documents:

NAFDAC Act (CAP N1 LFN 2004) – Establishes NAFDAC’s authority and regulatory mandate.
NAFDAC Pharmacovigilance Regulations/Guidelines – Outline AE reporting procedures, timelines, and obligations for MAHs.
Nigeria National Pharmacovigilance Policy – Broad framework for post-marketing surveillance.

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North Macedonia

NCA: Agency for Medicines and Medical Devices (MALMED) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Although not an EU member, North Macedonia is progressively aligning with EU regulatory standards.
A local pharmacovigilance contact (often a pharmacist or physician registered in the country) is generally required.
Responsibilities include adverse event reporting, maintaining PV documentation, and liaising with MALMED.
Formal QPPV structures may not fully mirror EU requirements but follow similar principles of ensuring product safety.

Normative Documents:

Law on Medicinal Products and Medical Devices – Governs all aspects of pharmaceutical regulation.
By-Laws / MALMED Guidelines – Detailed instructions on product registration, safety reporting, and compliance.
EU/ICH References – MALMED often references EU directives and ICH guidelines as it harmonizes local regulations with international standards.

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Norway

NCA: Norwegian Medicines Agency (NoMA / Statens legemiddelverk) under the Ministry of Health and Care Services

QPPV/LQPPV/LCPPV Requirements:

As part of the European Economic Area (EEA), Norway follows EU pharmacovigilance legislation.
A Qualified Person for Pharmacovigilance (QPPV) is required; they must be located in the EU/EEA.
A local contact in Norway is often designated (though not always mandatory) to handle communication in Norwegian and facilitate adverse event reporting to NoMA.
Responsibilities include maintaining a Pharmacovigilance System Master File (PSMF) and adhering to EU Good Pharmacovigilance Practices (GVP).

Normative Documents:

Norwegian Medicines Act (Legemiddelloven) – Implements EU directives, forming the legal framework for regulating medicinal products in Norway.
EU Regulations & Directives – Including Directive 2001/83/EC and Regulation (EC) No 726/2004, incorporated via EEA agreements.
Good Pharmacovigilance Practices (GVP) – Applied EEA-wide, detailing operational PV requirements.
Norwegian Medicines Agency Guidelines – Provide country-specific instructions on submissions, reporting timelines, and compliance procedures.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Oman

Oman

NCA: The Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) under the Ministry of Health (MoH)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Oman are required to appoint a Qualified Person for Pharmacovigilance (QPPV). The QPPV must be permanently and continuously available and should reside in Oman or any other Gulf Cooperation Council (GCC) country. For multinational MAHs without a scientific office in any GCC country, a Local Safety Responsible (LSR) can be designated on behalf of the local agent in Oman. Local MAHs must have a dedicated QPPV residing in Oman. The QPPV is responsible for establishing and maintaining the pharmacovigilance system, ensuring the collection, assessment, and reporting of adverse drug reactions (ADRs) to the DPV&DI. The names and 24-hour contact details of the nominated QPPV and their alternate during absence should be submitted to the DPV&DI.

Normative Documents:

Guideline on Good Pharmacovigilance Practices in Oman for MAHs/Pharmaceutical Companies: This guideline provides comprehensive instructions on the requirements, procedures, roles, and activities in the field of pharmacovigilance for MAHs in Oman. It covers aspects such as pharmacovigilance systems, risk management, adverse reaction reporting, and safety communication.
Circular No. 142 of 2024: Issued by the MoH, this circular requests the submission of Qualified Person for Pharmacovigilance (QPPV) details and associated documents to ensure compliance with regulatory requirements.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «P» (Pakistan, Palau,..)

Сomplete list of countries: Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal.

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Pakistan

NCA: Drug Regulatory Authority of Pakistan (DRAP)

QPPV/LQPPV/LCPPV Requirements:

Local PV Contact is mandated for Marketing Authorization Holders (MAHs).

The designated person (often a pharmacist or physician) must be based in Pakistan and is responsible for:

Adverse event (AE) reporting to DRAP.
Coordinating risk management plans and safety updates.
Maintaining the Pharmacovigilance System Master File (PSMF) or equivalent local file.

DRAP issues specific guidelines on AE reporting timelines and procedures.

Normative Documents:

DRAP Act, 2012 – Core legislation defining DRAP’s authority and responsibilities.
Pharmaceutical Rules & Regulations – Include licensing, registration processes, and basic pharmacovigilance obligations.
DRAP Guidelines / Circulars – Detail AE reporting forms, timelines, and risk management requirements.
WHO / ICH References – Pakistan often aligns with WHO/ICH standards where applicable.

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Palau

NCA: The Ministry of Health and Human Services

QPPV/LQPPV/LCPPV Requirements:

No formal QPPV framework (as seen in the EU/EEA).
Adverse event reporting systems are generally minimal; any major safety concerns are handled case-by-case through the Ministry of Health.
A local contact (often a pharmacist or healthcare provider) may be informally necessary for product importation or distribution licensing.

Normative Documents:

Public Health and Pharmacy Legislation – Any existing health or pharmacy-related acts/regulations (not widely published).
Ministry Circulars / Policy Directives – The Ministry of Health may issue ad hoc guidelines or directives on medicinal importation, distribution, and safety considerations.
Regional/WHO Guidance – Palau typically aligns with WHO recommendations or Pacific regional protocols on essential medicines and basic pharmacovigilance practices.

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Panama

NCA: The Dirección Nacional de Farmacia y Drogas under the Ministerio de Salud (MINSA)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV, but a local pharmacovigilance contact (usually a pharmacist) is required for product registration and post-marketing safety.
Responsible for adverse event reporting, ensuring compliance with local safety regulations, and acting as liaison with MINSA.

Normative Documents:

Law No. 1 (10 January 2001) – Provides a foundation for the regulation of pharmaceuticals and related products.
Executive Decrees / Resolutions issued by MINSA – Detail the procedures for registration, PV obligations, and AE reporting timelines.
Official Gazette (Gaceta Oficial) – Publishes enacted laws, decrees, and updates.
PAHO/WHO Guidelines – May be referenced for broader pharmacovigilance practices and standards.

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Papua New Guinea

NCA: Pharmacy Board of Papua New Guinea and the Medicines and Cosmetics Board under the National Department of Health (NDoH)

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system.
A local contact person (e.g., a pharmacist) is typically needed for product registration and liaising with the NDoH on safety matters.
Formal pharmacovigilance structures are limited; adverse event reporting tends to be on a case-by-case basis, often guided by WHO recommendations and local guidelines.

Normative Documents:

Medicines and Cosmetics Act – Core legislation governing pharmaceuticals and related products.
Pharmacy Board Regulations – Outline the licensing and practice standards for pharmacies/pharmacists.
National Department of Health Circulars/Guidelines – Occasional directives on import procedures, product registration, and drug safety reporting.
WHO/Regional Pacific Guidelines – PNG often follows WHO guidance for essential medicines and basic pharmacovigilance.

_________________________________

Paraguay

NCA: Dirección Nacional de Vigilancia Sanitaria (DINAVISA) under the Ministry of Public Health and Social Welfare (Ministerio de Salud Pública y Bienestar Social, MSPBS).

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV framework, but a local representative for pharmacovigilance (often a pharmacist or physician) is required.
Responsible for adverse event reporting, liaising with DINAVISA, and ensuring compliance with safety obligations.
Must be based in Paraguay and registered with the relevant professional body.

Normative Documents:

Ley 836/80 (Código Sanitario) – Underpins public health regulations, including pharmaceuticals.
DINAVISA Resolutions / Decrees – Detail procedures for drug registration, importation, and PV reporting timelines.
Official Gazette (Gaceta Oficial) – Publishes enacted laws and regulatory updates.
MERCOSUR Regulations – Paraguay, as a MERCOSUR member, may align with regional directives on drug regulation.

Peru

NCA: Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) under the Ministry of Health (Ministerio de Salud, MINSA).

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV, but a local pharmacovigilance contact (often a pharmacist or physician) is required for product registration.
Responsible for adverse event reporting, safety monitoring, and liaising with DIGEMID.
Must be based in Peru and registered with the appropriate professional council.

Normative Documents:

Decreto Legislativo N° 1161 (Ley de Organización y Funciones del MINSA) – Defines MINSA’s scope and structure, covering DIGEMID’s role.
Reglamento del Registro Sanitario (e.g., D.S. N° 016-2011-SA) – Outlines procedures for drug registration and licensing.
DIGEMID Guidelines & Directives – Detail pharmacovigilance reporting requirements, timelines, and risk management obligations.
Official Gazette (El Peruano) – Publishes enacted laws, decrees, and regulatory updates.

_________________________________

Philippines

NCA: Food and Drug Administration (FDA) under the Department of Health (DOH).

QPPV/LQPPV/LCPPV Requirements:

A Qualified Person for Pharmacovigilance (QPPV) or local PV contact is mandated for Marketing Authorization Holders (MAHs).
Typically a Philippines-licensed pharmacist (or, in certain cases, a physician) residing in the country.
Duties include adverse event reporting, maintaining the local PV system, and serving as liaison with the FDA.
Specific guidelines and timelines for AE reporting are laid out in FDA circulars/administrative orders.

Normative Documents:

Republic Act (RA) No. 9711 – The FDA Act of 2009, establishing and defining FDA’s authority.
FDA Circulars / Administrative Orders – Detailed instructions on pharmacovigilance obligations, AE reporting formats, and risk management.
ASEAN Guidelines – The Philippines aligns with certain ASEAN harmonization initiatives affecting drug registration and safety monitoring.
FDA Website – Official updates and notices regarding local regulatory requirements.

_________________________________

Poland

NCA: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Qualified Person for Pharmacovigilance (QPPV): As an EU Member State, Poland requires MAHs to appoint a QPPV located within the EU/EEA.
Local Contact: A local PV contact (often a pharmacist or physician fluent in Polish) is typically needed to handle adverse event reporting and liaise with URPL.
Responsibilities include maintaining the Pharmacovigilance System Master File (PSMF), ensuring compliance with Good Pharmacovigilance Practices (GVP), and meeting reporting timelines.

Normative Documents:

Pharmaceutical Law (Prawo farmaceutyczne) – Poland’s primary legislation governing medicinal products, incorporating EU directives (e.g., Directive 2001/83/EC).
EU Regulations & Directives – Notably Regulation (EC) No 726/2004 and the EU’s GVP modules, directly applicable or transposed into Polish law.
URPL Guidelines & Communications – Provide country-specific instructions for submission processes, AE reporting formats, and risk management obligations.
Official Journal of Laws (Dziennik Ustaw) – Publishes enacted laws and regulations.

_________________________________

Portugal

NCA: INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Qualified Person for Pharmacovigilance (QPPV): As an EU Member State, Portugal requires a QPPV residing in the EU/EEA.
Local PV Contact: A local contact fluent in Portuguese is often designated to liaise with INFARMED.
Responsibilities include adverse event reporting, maintaining the Pharmacovigilance System Master File (PSMF), and ensuring compliance with Good Pharmacovigilance Practices (GVP).

Normative Documents:

Decree-Law No. 176/2006 – Primary Portuguese legislation implementing EU pharmaceutical directives.
EU Pharmaceutical Legislation (e.g., Directive 2001/83/EC, Regulation (EC) No 726/2004) – Defines overarching pharmacovigilance and MAH obligations.
INFARMED Guidelines & Circulars – Country-specific instructions on reporting timelines, risk management plans, and dossier submission.
Official Journal of the Portuguese Republic (Diário da República) – Publishes enacted laws and decrees.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Qatar

Qatar

NCA: Pharmacy and Drug Control Department under the Ministry of Public Health (MoPH)

QPPV/LQPPV/LCPPV Requirements: Qatar does not currently mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a local contact person for pharmacovigilance (LCPPV). However, pharmaceutical companies are encouraged to establish robust pharmacovigilance systems to monitor and report adverse drug reactions (ADRs). The MoPH emphasizes the importance of medication safety and has plans to enhance pharmacovigilance activities within the country.

Normative Documents:

Clinical Guidelines: The MoPH provides clinical guidelines to ensure the safe and effective use of medicines. While these guidelines do not specifically address pharmacovigilance requirements, they contribute to the overall framework for medication safety in Qatar.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Romania, Russia, Rwanda

Romania

NCA: The National Agency for Medicines and Medical Devices of Romania (NAMMDR)

QPPV/LQPPV/LCPPV Requirements: In line with European Union (EU) regulations, Marketing Authorization Holders (MAHs) in Romania are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who is permanently and continuously available. Additionally, the NAMMDR may request the nomination of a local contact person for pharmacovigilance (LCPPV) at the national level, who reports to the EU QPPV. This local contact is responsible for specific pharmacovigilance activities within Romania, such as conducting local literature screening, following up on cases, and distributing Direct Healthcare Professional Communications (DHPCs).

Normative Documents:

Law No. 95/2006 on Healthcare Reform: This law transposes EU pharmacovigilance directives into national legislation and outlines the requirements for pharmacovigilance activities, including the roles and responsibilities of the QPPV and local contact persons.
Guideline on Good Pharmacovigilance Practices (GVP): Romania adheres to the GVP guidelines established by the European Medicines Agency (EMA), which provide comprehensive instructions on the establishment and maintenance of pharmacovigilance systems.

______________________________

Russia

NCA: Russian Federation Federal Service for Surveillance in Healthcare

QPPV/LQPPV/LCPPV Requirements: In accordance with the Eurasian Economic Union (EAEU) Good Pharmacovigilance Practices (GVP), Marketing Authorization Holders (MAHs) in Russia are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV must reside within the EAEU member states and is responsible for establishing and maintaining the MAH’s pharmacovigilance system. Additionally, the QPPV should be directly subordinate to the chief executive officer of the MAH, ensuring independence from other departments.

Normative Documents:

Federal Law No. 61-FZ “On Circulation of Medicines”: This law provides the legal framework for the regulation of medicines in Russia, including pharmacovigilance activities.
Roszdravnadzor Order No. 1071 (2017): This order approves the pharmacovigilance procedure, establishing requirements for conducting pharmacovigilance in Russia.
EAEU Good Pharmacovigilance Practice (GVP) Guidelines: These guidelines provide a harmonized approach to pharmacovigilance across EAEU member states, including Russia.

Rwanda

NCA: The Rwanda Food and Drugs Authority (Rwanda FDA)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Rwanda are required to establish a pharmacovigilance system and appoint a Qualified Person for Pharmacovigilance (QPPV). The QPPV is responsible for the pharmacovigilance system and must ensure the collection, assessment, and reporting of adverse drug reactions (ADRs) to the Rwanda FDA. Additionally, all stakeholders dealing with pharmaceutical products and medical devices are required to appoint a focal person for the coordination of pharmacovigilance activities.

Normative Documents:

Regulations Governing Pharmacovigilance of Pharmaceutical Products and Medical Devices: These regulations provide a legal framework for effective and efficient pharmacovigilance of pharmaceutical products and medical devices in Rwanda.
Guidelines on Safety and Vigilance of Medical Products and Health Technologies: These guidelines offer detailed procedures for stakeholders in carrying out safety and vigilance activities related to medical products and health technologies.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «S» (Saint Kitts and Nevis, Saint Lucia,..)

Сomplete list of countries: Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, Spain, Sri Lanka, Sudan, Sudan (South), Suriname, Sweden, Switzerland, Syria.

__________________________________

Saint Kitts and Nevis

NCA: The Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

While not strictly mandatory, MAHs are encouraged to appoint a Local Pharmacovigilance Officer based in Saint Kitts and Nevis to manage adverse event reporting and ensure compliance with local regulations.

Normative Documents:

Pharmacy Act: Primary legislation governing pharmacy practices, drug registration, and regulation of pharmaceutical entities.
Ministry of Health Regulations and Guidelines: Detailed procedures and operational guidelines issued by the Ministry of Health.
World Health Organization (WHO) Guidelines: International standards informing local pharmacovigilance and regulatory procedures.

______________________________

Saint Lucia

NCA: Pharmacy Council under the Ministry of Health in Saint Lucia.

QPPV/LQPPV/LCPPV Requirements:

Specific information regarding the requirements for QPPV, LQPPV, or LCPPV roles in Saint Lucia is not readily available in the current legislative documents.

Normative Documents:

Pharmacy Act
OECS Medicines Formulary (OMF)
Standard Treatment Guidelines (STG)

______________________________

Saint Vincent and the Grenadines

NCA: The Pharmacy Council under the Ministry of Health, Wellness, and the Environment

QPPV/LQPPV/LCPPV Requirements:

Specific information regarding the requirements for Qualified Person for Pharmacovigilance (QPPV), Local Qualified Person for Pharmacovigilance (LQPPV), or Local Contact Person for Pharmacovigilance (LCPPV) roles in Saint Vincent and the Grenadines is not readily available in the current legislative documents.

Normative Documents:

Pharmacy Act No. 54 of 2002
Pharmaceutical Country Profile (2012)
Essential Medicines List (EML)

______________________________

Samoa

NCA: The Ministry of Health (MoH)

QPPV/LQPPV/LCPPV Requirements:

Specific information regarding the requirements for a Qualified Person for Pharmacovigilance (QPPV), Local Qualified Person for Pharmacovigilance (LQPPV), or Local Contact Person for Pharmacovigilance (LCPPV) in Samoa is not readily available in the current legislative documents. It is advisable for pharmaceutical companies operating in Samoa to consult directly with the Ministry of Health to obtain detailed information on any local pharmacovigilance requirements.

Normative Documents:

Samoa Medicines Act: This Act provides the legal framework for the regulation of medicines and medical devices in Samoa
Good Manufacturing Practices (GMP): Samoa adheres to GMP guidelines to ensure the quality of pharmaceutical products
Pharmacovigilance Guidelines: While specific guidelines for pharmacovigilance in Samoa are not detailed in the available sources, the Ministry of Health is responsible for monitoring the safety of medicines and may have established procedures for reporting and assessing adverse drug reactions.

______________________________

San Marino

NCA: The Pharmaceutical Regulation Authority under the Ministry of Health and Social Security

QPPV/LQPPV/LCPPV Requirements:

Specific information regarding the requirements for a Qualified Person for Pharmacovigilance (QPPV), Local Qualified Person for Pharmacovigilance (LQPPV), or Local Contact Person for Pharmacovigilance (LCPPV) in San Marino is not readily available in the current legislative documents.

Normative Documents:

Good Manufacturing Practices (GMP): Pharmaceutical manufacturers in San Marino must comply with GMP guidelines to ensure the quality of pharmaceutical products
Pharmacovigilance Guidelines: San Marino has established legal provisions for monitoring adverse drug reactions and requires Marketing Authorization holders to continuously monitor the safety of their products and report to the regulatory authority.

______________________________

Sao Tome and Principe

NCA: The Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

There are no specific requirements for a QPPV/LQPPV/LCPPV

Normative Documents:

Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP):
Essential Medicines List (EML
African Medicines Regulatory Harmonization (AMRH) Initiative.

______________________________

Saudi Arabia

NCA: the Saudi Food and Drug Authority (SFDA)

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) are required to appoint a LQPPV. The LQPPV must reside in Saudi Arabia and be a full-time employee of the MAH. They should hold a minimum of a bachelor’s degree in pharmacy or medicine and be licensed by the Saudi Commission for Health Specialties.

Normative Documents:

Guideline on Good Pharmacovigilance Practices (GVP):
Pharmacovigilance Sub-System File (PSSF): MAHs are required to develop and maintain a PSSF, which documents the local pharmacovigilance system in Saudi Arabia.
Regulatory Framework for Drug Approval: The SFDA has established a regulatory framework that outlines the procedures and requirements for drug approval in Saudi Arabia. This includes guidelines on Good Manufacturing Practices (GMP) and other standards to ensure the quality and safety of pharmaceutical products.

______________________________

Senegal

NCA: The Agence Sénégalaise de Réglementation Pharmaceutique (ARP)

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for a Qualified Person for Pharmacovigilance (QPPV) are not detailed in the available sources

Normative Documents:

Loi n°2023-06 du 13 juin 2023 relative aux médicaments
Décret n°2022-824 portant création et fixant les règles d’organisation et de fonctionnement de l’Agence sénégalaise de réglementation pharmaceutique (ARP): This decree establishes the ARP and outlines its organizational structure and operational procedures.
Guide des demandes d’importation et d’exportation de médicaments et autres produits de santé: This guide provides detailed procedures for the import and export of medicines and health products, ensuring compliance with national regulations.
Liste nationale des médicaments et produits essentiels du Sénégal – Version 2022: This document lists the essential medicines and health products approved for use in Senegal, guiding procurement and ensuring the availability of necessary drugs within the healthcare system.

______________________________

Serbia

NCA: The Medicines and Medical Devices Agency of Serbia (ALIMS),

QPPV/LQPPV/LCPPV Requirements:

The QPPV appointment is required, must reside in Serbia and is responsible for establishing and maintaining the MAH’s pharmacovigilance system, ensuring compliance with national regulations, and overseeing all pharmacovigilance activities, including adverse event reporting and safety data management.

Normative Documents:

Law on Medicinal Products and Medical Devices:
Good Manufacturing Practice (GMP) Guidelines
Good Distribution Practice (GDP) Guidelines.

______________________________

Seychelles

NCA: The Seychelles Medicines Control Authority (SMCA)

QPPV/LQPPV/LCPPV Requirements:

Specific information regarding the requirements for a Qualified Person for Pharmacovigilance (QPPV), Local Qualified Person for Pharmacovigilance (LQPPV), or Local Contact Person for Pharmacovigilance (LCPPV) in Seychelles is not readily available in the current legislative documents.

Normative Documents:

National Medicine Policy
Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP
Import Procedures for Pharmaceutical Products

______________________________

Sierra Leone

NCA: The Pharmacy Board of Sierra Leone (PBSL)

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in Sierra Leone are required to appoint a Qualified Person for Pharmacovigilance (QPPV) who resides in the country.

Normative Documents:

Guide for Safety Monitoring of Medicines in Sierra Leone
Guidelines for Medicinal Product Registration
Guidelines for Pharmacovigilance Inspections.

______________________________

Singapore

NCA: The Health Sciences Authority (HSA)

QPPV/LQPPV/LCPPV Requirements:

In Singapore, Marketing Authorization Holders (MAHs) are required to have a pharmacovigilance system in place to monitor the safety of their products. While the specific designation of a Qualified Person for Pharmacovigilance (QPPV) is not explicitly mandated, MAHs must ensure that they can effectively manage pharmacovigilance activities, including adverse event reporting and risk management. The HSA’s Vigilance and Compliance Branch oversees these activities to ensure compliance with regulatory requirements.

Normative Documents:

Guidance on Therapeutic Product Registration in Singapore
Guidance Documents for Therapeutic Products
Adverse Event Reporting Guidelines.

______________________________

Slovakia

NCA: The State Institute for Drug Control (ŠÚKL)

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in Slovakia are required to have an appropriate pharmacovigilance system in place. While the Qualified Person for Pharmacovigilance (QPPV) may be based outside Slovakia, it is expected that MAHs appoint a local pharmacovigilance contact or manager who can communicate in Slovak or Czech.

Normative Documents:

Act on Medicinal Products
Good Pharmacovigilance Practices (GVP
Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Guidelines.

______________________________

Slovenia

NCA: The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

QPPV/LQPPV/LCPPV Requirements:

Appointment of QPPV is required. JAZMP has the authority to request the appointment of a local pharmacovigilance contact person if deemed necessary.

Normative Documents:

Medicinal Products Act
Formularium Slovenicum
Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Guidelines.

______________________________

Solomon Islands

NCA: The Pharmacy and Poisons Board (PPB), operating under the Ministry of Health and Medical Services.

QPPV/LQPPV/LCPPV Requirements:

The Solomon Islands do not have a formal pharmacovigilance system in place. Consequently, there are no specific requirements for a Qualified Person for Pharmacovigilance (QPPV), Local Qualified Person for Pharmacovigilance (LQPPV), or Local Contact Person for Pharmacovigilance (LCPPV).

Normative Documents:

Pharmacy and Poisons Act
Good Manufacturing Practices (GMP
National Medicines Policy.

______________________________

Somalia

NCA: The National Medicines Regulatory Authority (NMRA) under the Federal Ministry of Health and Human Services

QPPV/LQPPV/LCPPV Requirements:

The NMRA has issued the Somali Pharmacovigilance Guideline, which delineates requirements for pharmacovigilance activities. Marketing Authorization Holders (MAHs) are required to establish a pharmacovigilance system and appoint a Qualified Person for Pharmacovigilance (QPPV).

Normative Documents:

Somali Pharmacovigilance Guideline
National Medicines Policy (2014)
Somali Essential Medicines List (2019).

______________________________

South Africa

NCA: The South African Health Products Regulatory Authority (SAHPRA)

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in South Africa are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV must reside in South Africa and is responsible for ensuring that the MAH meets its legal obligations for monitoring the safety of products marketed in the country.

Normative Documents:

Guideline on Pharmacovigilance Systems
Pharmacovigilance Inspections for Human Medicinal Products
Good Manufacturing Practice (GMP) Guidelines
Good Distribution Practice (GDP) Guidelines.

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Spain

NCA: The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) under the Spanish Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who is permanently and continuously at their disposal. Additionally, according to Royal Decree 577/2013, MAHs must designate a local contact person for pharmacovigilance in Spain.

Normative Documents:

Royal Decree 577/2013
Good Pharmacovigilance Practices (GVP)
Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Guidelines.

______________________________

Sri Lanka

NCA: The National Medicines Regulatory Authority (NMRA)

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for a Qualified Person for Pharmacovigilance (QPPV) are not detailed in the available sources.

Normative Documents:

National Medicines Regulatory Authority Act, No. 5 of 2015
Guidelines on Registration of Medicines
Guideline on Pharmacovigilance
Guideline on Good Manufacturing Practices (GMP).

______________________________

Sudan

NCA: The National Medicines and Poisons Board (NMPB) under the Directorate General of Pharmacy within the Federal Ministry of Health.

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) are required to appoint a Qualified Person for Pharmacovigilance (QPPV). The QPPV must be a qualified pharmacist residing in Sudan, with documented experience and training in all aspects of pharmacovigilance.

Normative Documents:

Requirements for Good Pharmacovigilance Practices in Sudan
Pharmacy, Poisons, Cosmetics and Medical Devices Act (2001)
Good Manufacturing Practices (GMP) Guidelines.

______________________________

Sudan, South

NCA: The National Medicines and Poisons Board (NMPB)

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for a QPPV/LQPPV/LCPPV in South Sudan are not explicitly detailed in the current legislative documents.

Normative Documents:

Drug and Food Control Authority Act, 2012 (Act No. 37):
South Sudan Essential Medicines List (SSEML) 2018
Pharmaceutical Policy and Strategy
Good Pharmacovigilance Practices (GVP).

______________________________

Suriname

NCA: The Registration Committee (RC) under the Ministry of Health (MOH)

QPPV/LQPPV/LCPPV Requirements:

As of the latest available information, Suriname has a low level of pharmacovigilance regulatory requirements, and no formal system for reporting adverse drug reactions is currently implemented. Consequently, there are no specific mandates for appointing a QPPV/LQPPV/LCPPV.

Normative Documents:

Amendment of the Regulation on the Practice of Medicine in Suriname (G.B. 1973 no. 1)
Packaged Medicines Decree (G.B. 1973 No. 155)
Amendment of the Packaged Medicinal Products Decree (G.B. 1986 no. 56)
Further Amendment of the Packaged Medicines Decree (G.B. 2017 no. 15).

______________________________

Sweden

NCA: The Swedish Medical Products Agency (MPA) under the Ministry of Health and Social Affairs

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) in Sweden are required to have a pharmacovigilance system in place, overseen by a Qualified Person Responsible for Pharmacovigilance (QPPV).

Normative Documents:

Guideline on Good Pharmacovigilance Practices (GVP
Regulatory Framework for Clinical Trials on Medicinal Products for Human Use.

______________________________

Switzerland

NCA: The Swiss Agency for Therapeutic Products (Swissmedic) under the Federal Department of Home Affairs

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) are required to designate a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV does not necessarily have to reside in Switzerland but must be appropriately qualified, with documented experience in all aspects of pharmacovigilance.

Normative Documents:

Therapeutic Products Act (TPA)
Ordinance on Pharmacovigilance (PV Ordinance)
Good Pharmacovigilance Practices (GVP).

______________________________

Syria

NCA: The Ministry of Health (MoH)

QPPV/LQPPV/LCPPV Requirements:

Specific requirements for appointing a QPPV/LQPPV/LCPPV are not explicitly detailed in the available sources.

Normative Documents:

National Drug Policy
Good Manufacturing Practices (GMP) Guidelines
Pharmacovigilance Guidelines.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «T» (Taiwan, Tajikistan,..)

Сomplete list of countries: Taiwan, Tajikistan, Tanzania, Thailand, Togo, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Tuvalu.

___________________________________

Taiwan

NCA: Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV framework (i.e., the term “QPPV” is not officially used).
A local pharmacovigilance responsible person (often called an “RPP” or “PV responsible person”) is mandated for holders of product licenses in Taiwan.
This local contact must be based in Taiwan, typically a pharmacist or other qualified healthcare professional.
Responsibilities include adverse event reporting, risk management plan (RMP) submissions (if required), and routine liaison with TFDA regarding product safety.

Normative Documents:

Pharmaceutical Affairs Act – Core legislation regulating the manufacture, import, and marketing of drugs.
TFDA Regulations & Guidelines – Specify registration procedures, post-marketing surveillance (PMS) and reporting timelines, plus technical requirements.
Good Pharmacovigilance Practices (GVP) Guidelines – Adapted for the Taiwanese regulatory environment, detailing key responsibilities of the local PV person.

______________________________

Tajikistan

NCA: Drug Registration department under the Ministry of Health and Social Protection of the Population

QPPV/LQPPV/LCPPV Requirements:

No formal EU-style QPPV system.
A local PV representative is generally required for product registration and safety liaison.
Adverse event reporting processes are modest; major safety concerns are escalated to the Ministry of Health on a case-by-case basis.

Normative Documents:

Law on Medicines and Pharmaceutical Activities – Governs registration, distribution, and control of medicinal products.
Ministerial Orders / Decrees – Detail local registration procedures and any evolving pharmacovigilance obligations.
WHO Guidelines – Often inform Tajikistan’s national PV framework and best practices.

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Tanzania

NCA: Tanzania Medicines and Medical Devices Authority (TMDA) under the Ministry of Health, Community Development, Gender, Elderly and Children

QPPV/LQPPV/LCPPV Requirements:

Marketing Authorization Holders (MAHs) are required to appoint a Local Pharmacovigilance Officer.
Typically a licensed pharmacist or physician registered with the relevant Tanzanian professional bodies.
Must possess adequate training and expertise in pharmacovigilance practices.
Residency: The designated pharmacovigilance officer must be based in Tanzania to ensure effective communication and timely reporting.

Normative Documents:

Comprehensive Framework: Tanzania’s regulatory environment is primarily governed by the Medicines and Medical Devices Act, 2019, supplemented by detailed regulations and TMDA-issued guidelines.
Pharmacovigilance Emphasis: Robust pharmacovigilance practices are supported by specific TMDA guidelines and adherence to international standards like WHO’s GVP.
Access to Documents: Key normative documents can be accessed through the Tanzania Medicines and Medical Devices Authority (TMDA) official website and the Tanzania Gazette.

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Thailand

NCA: Thai Food and Drug Administration (Thai FDA) Agency under the Ministry of Public Health (MOPH).

QPPV/LQPPV/LCPPV Requirements:

Pharmacovigilance Responsible Person (RPP) is required.
Qualifications: Must be a licensed pharmacist, physician, or another qualified healthcare professional.
Should have specialized training and expertise in pharmacovigilance and drug safety.
Residency: The RPP must be based in Thailand to ensure effective communication and timely reporting with the Thai FDA.

Normative Documents:

Food Act B.E. 2522 (1979)
Drug Act B.E. 2522 (1979)
Thai FDA Guidelines and Circulars
Regulations on the Manufacture, Import, Export, and Distribution of Drugs
International Guidelines and Standards: World Health Organization (WHO) Guidelines and International Council for Harmonisation (ICH) Guidelines.

______________________________

Togo

NCA: The Direction de la Pharmacie et du Médicament (DPM) under Togo’s Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

MAHs must appoint a Local Pharmacovigilance Officer based in Togo to manage safety reporting and compliance.

Normative Documents:

Loi Relative à la Santé Publique et à la Pharmacie
Règlements et Décrets Ministériels
Guidelines de la Direction de la Pharmacie et du Médicament
Normes et Directives Régionales Economic and Monetary Community of Central Africa (CEMAC)
World Health Organization (WHO) Guidelines.

______________________________

Tonga

NCA: The Ministry of Health and Women’s Affairs

QPPV/LQPPV/LCPPV Requirements:

MAHs must appoint a Local Pharmacovigilance Officer based in Tonga to manage adverse event reporting and ensure compliance with local regulations.

Normative Documents:

Governed by the Public Health Act and detailed Pharmacy and Medicines Regulations, supplemented by Ministry of Health Circulars and WHO Guidelines.

______________________________

Trinidad and Tobago

NCA: The Pharmaceutical Products Division (PPD) within the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

MAHs must appoint a Local Pharmacovigilance Officer based in Trinidad and Tobago to manage adverse event reporting and ensure compliance with local regulations.

Normative Documents:

Governed primarily by the Medicines Act and detailed Pharmaceutical Products Regulations, supplemented by PPD guidelines and regional CARICOM harmonization initiatives.

______________________________

Tunisia

NCA: The Agence Nationale de la Médicament (ANM) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

MAHs must appoint a Local Pharmacovigilance Officer based in Tunisia to manage adverse event reporting and ensure compliance with local regulations.

Normative Documents:

Governed primarily by the Code de la Santé Publique and the Law on the National Medicines Agency, supplemented by detailed ANM regulations, guidelines, and regional CEMAC directives.

______________________________

Turkey

NCA: The Turkish Medicines and Medical Devices Agency (TİTCK)

QPPV/LQPPV/LCPPV Requirements:

MAHs must appoint Local Pharmacovigilance Officer (Equivalent to QPPV) based in Turkey to manage safety reporting and ensure compliance with local regulations. Qualifications: Licensed pharmacist, physician, or qualified healthcare professional. Must reside in Turkey.

Normative Documents:

Turkish Medicines and Medical Devices Law (6578): Governs the registration, distribution, and control of medicinal products and devices.
TİTCK Regulations and Guidelines: Detailed procedures for drug/device registration and pharmacovigilance practices.
International Guidelines: ICH Guidelines: Adopted to align with global pharmacovigilance standards; WHO Guidelines: Inform local pharmacovigilance practices.

______________________________

Turkmenistan

NCA: Center for Registration of Medicinal Products and State Control of their Quality under the Ministry of Health and Medical Industry of Turkmenistan

QPPV/LQPPV/LCPPV Requirements:

Turkmenistan does not mandate the appointment of a Local Pharmacovigilance Officer for Marketing Authorization Holders (MAHs).

Normative Documents:

Law of Turkmenistan on drug provision,12 January 2023.
No. 320 Order “On the procedure for monitoring side effects of medicines”, 05 October 2017
World Health Organization (WHO) Guidelines

______________________________

Tuvalu

NCA: The Ministry of Health

QPPV/LQPPV/LCPPV Requirements:

Tuvalu does not require MAHs to appoint a Local Pharmacovigilance Officer. Instead, pharmacovigilance activities are managed directly through the Ministry.

Normative Documents:

Public Health Act: Foundational legislation governing public health and pharmaceutical regulation in Tuvalu
Ministry of Health Regulations and Guidelines: Detailed procedures and operational guidelines issued by the Ministry of Health
World Health Organization (WHO) Guidelines: International standards that inform Tuvalu’s pharmacovigilance framework and regulatory procedures.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «U» (Uganda, Ukraine,..)

Сomplete list of countries: Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan.

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Uganda

NCA: The National Drug Authority (NDA) under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements: Uganda does not currently mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV) for Marketing Authorization Holders (MAHs). However, the NDA emphasizes the importance of pharmacovigilance activities, including the reporting of adverse drug reactions (ADRs) and the monitoring of medicine safety. Healthcare professionals and MAHs are encouraged to actively participate in the national pharmacovigilance system to ensure patient safety.

Normative Documents:

National Medicines Policy (2015): This policy outlines the government’s commitment to ensuring the availability, accessibility, and rational use of essential medicines and health supplies. It serves as a framework for all activities related to medicines regulation, including pharmacovigilance.
Uganda Clinical Guidelines (2023): These guidelines provide comprehensive recommendations for the diagnosis and management of common conditions in Uganda, including guidance on medicine use and safety monitoring.
Essential Medicines and Health Supplies List for Uganda (EMHSLU) 2023: This list comprises safe, efficacious, and cost-effective medicines and health supplies that meet the healthcare needs of the majority of the Ugandan population. It supports the rational use of medicines and underpins pharmacovigilance efforts.

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Ukraine

NCA: The State Expert Center (SEC) of the Ministry of Health of Ukraine

QPPV/LQPPV/LCPPV Requirements:

Qualified Person for Pharmacovigilance (QPPV): Marketing Authorization Holders (MAHs) are required to appoint a QPPV who is responsible for the establishment and maintenance of the pharmacovigilance system. The QPPV must have the necessary qualifications and experience to fulfill these responsibilities.
Local Qualified Person for Pharmacovigilance (LQPPV): If the MAH is located outside Ukraine, they must designate a Local Qualified Person for Pharmacovigilance (LQPPV) in Ukraine. The LQPPV should have a higher medical or pharmaceutical education and the necessary training to manage pharmacovigilance activities within the country.

Normative Documents:

Order No. 898 of the Ministry of Health of Ukraine (December 27, 2006): This order, titled “The Procedure for Pharmacovigilance,” outlines the pharmacovigilance system in Ukraine and is based on international standards, including EU Directive 2001/83 and EU Council Regulation 2309/93.
Order No. 426 of the Ministry of Health of Ukraine (August 26, 2005): This order approves the procedure for conducting examinations of registration materials for medicinal products submitted for state registration, re-registration, and examination of materials on making changes to registration materials during the validity of the registration certificate.

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United Arab Emirates (UAE)

NCA: The Ministry of Health and Prevention (MOHAP)

QPPV/LQPPV/LCPPV Requirements:

Qualified Person for Pharmacovigilance (QPPV): Marketing Authorization Holders (MAHs) are required to appoint a QPPV who is responsible for the establishment and maintenance of the pharmacovigilance system. The QPPV must be a resident in the UAE, hold a degree in medicine or pharmacy, and have experience in pharmacovigilance, monitoring of side effects, and risk analysis.
Local Contact Person for Pharmacovigilance (LCPPV): If the QPPV is not based in the UAE, the MAH must designate a local contact person for pharmacovigilance. The LCPPV should have appropriate qualifications and experience to manage pharmacovigilance activities within the UAE.

Normative Documents:

UAE MOHAP Guidelines in Good Vigilance Practice (GVP) for Marketing Authorization Holders / Pharmaceutical Manufacturers in UAE: This guideline outlines the requirements for pharmacovigilance systems and quality systems that MAHs must have in place.
Approval of Pharmacovigilance Officer within UAE: This service enables companies to submit an application to approve and register their QPPV officers.
Evaluation of Pharmacovigilance Plan for Pharmaceutical Facility and its Subsidiaries: This service allows pharmaceutical companies and their subsidiaries to apply for their pharmacovigilance plan to be evaluated with the aim of registering and marketing medicines within the UAE.

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United Kingdom

NCA: The Medicines and Healthcare products Regulatory Agency (MHRA)

QPPV/LQPPV/LCPPV Requirements:

Location: Marketing Authorization Holders (MAHs) must have a QPPV who resides and operates in the UK or the European Economic Area (EEA). This individual is responsible for establishing and maintaining the pharmacovigilance system for UK-authorized products.
Responsibilities: The QPPV is accountable for the establishment and maintenance of the pharmacovigilance system, ensuring compliance with regulatory requirements, and serving as the main contact point for the MHRA on a 24/7 basis.

Pharmacovigilance System Master File (PSMF):

Location: The PSMF must be accessible electronically or physically within the UK upon request by the MHRA. It should detail the pharmacovigilance system in place for UK-authorized products.

Normative Documents:

Good Pharmacovigilance Practice (GPvP) Guidelines: The UK follows its own GPvP guidelines, which are aligned with international standards to ensure the safety monitoring of medicinal products.
Guidance on Pharmacovigilance Procedures: This document provides detailed procedures for MAHs regarding the reporting and management of pharmacovigilance activities in the UK.

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United States

NCA: The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) under the U.S. Food and Drug Administration (FDA)

QPPV/LQPPV/LCPPV Requirements: The United States does not require the appointment of a Qualified Person for Pharmacovigilance (QPPV) and Local Contact Person for Pharmacovigilance (LCPPV). Marketing Authorization Holders (MAHs) must establish pharmacovigilance systems and continuously monitor the safety of their products and the implementation of risk management strategies.

Normative Documents:

Federal Food, Drug, and Cosmetic Act (FDCA): This act provides the legal framework for the regulation of food, drugs, and cosmetics in the United States. It grants the FDA authority to oversee the safety of drugs and other products.
Code of Federal Regulations (CFR) Title 21: This section outlines the FDA’s regulations for drugs and medical devices for human use. It includes requirements for postmarketing safety reporting and pharmacovigilance activities.
FDA Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: This document provides recommendations on pharmacovigilance practices and the assessment of observational data regarding drugs, including biological products.
FDA Guidance for Industry: E2E Pharmacovigilance Planning: This guidance proposes a structure for a pharmacovigilance plan and a safety specification that summarizes the identified and potential risks of a product.

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Uruguay

NCA: The Ministry of Public Health (Ministerio de Salud Pública – MSP)

QPPV/LQPPV/LCPPV Requirements: Uruguay does not currently mandate the appointment of a Qualified Person for Pharmacovigilance (QPPV) or a Local Contact Person for Pharmacovigilance (LCPPV) for Marketing Authorization Holders (MAHs). However, pharmaceutical companies are encouraged to establish internal pharmacovigilance systems to monitor and report adverse drug reactions (ADRs) and ensure the safety of their products.

Normative Documents:

Ordinance No. 798/2014: Establishes the National Pharmacovigilance System, outlining the procedures for reporting and evaluating adverse events related to medicinal products.
Ordinance No. 292/2018: Introduces the modality of “additional surveillance” within the National Pharmacovigilance System, serving as an intermediate category between passive (spontaneous report) and active (intensive) pharmacovigilance.
Decree No. 38/2015: Regulates the registration and pharmacovigilance of biotechnological medicines, ensuring their safety and efficacy.

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Uzbekistan

NCA: The Center for Pharmaceutical Products Safety under the Ministry of Health

QPPV/LQPPV/LCPPV Requirements: The MAH must designate a local contact person for pharmacovigilance with appropriate qualifications and experience to manage pharmacovigilance activities within the country.

Normative Documents:

Order No. 13 of the Minister of Health of Uzbekistan dated March 9, 2018

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Vanuatu, Venezuela, Vietnam

Vanuatu

NCA: Vanuatu Medicines and Pharmaceutical Services (VMPS) under the Ministry of Health.

QPPV/LQPPV/LCPPV Requirements: Vanuatu’s pharmacovigilance framework is in the early stages of development. Currently, there is no explicit requirement for a Qualified Person for Pharmacovigilance (QPPV) or equivalent roles. However, the VMPS emphasizes the importance of adverse drug reaction (ADR) reporting and encourages healthcare professionals and pharmaceutical companies to participate in pharmacovigilance activities.

Normative Documents:

Medicines and Poisons Act: Governs the regulation of pharmaceuticals and medical devices in Vanuatu, including aspects related to pharmacovigilance.
National Medicines Policy: Outlines the national framework for ensuring the safety, efficacy, and quality of medicines, emphasizing the importance of pharmacovigilance activities.

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Venezuela

NCA: National Institute of Hygiene “Rafael Rangel” under the Ministry of People’s Power for Health

QPPV/LQPPV/LCPPV Requirements: Venezuela mandates that Marketing Authorization Holders (MAHs) appoint a local pharmacovigilance responsible person. This individual is accountable for the establishment and maintenance of the pharmacovigilance system, ensuring the collection, assessment, and reporting of adverse drug reactions (ADRs) to the regulatory authorities. While the term “Qualified Person for Pharmacovigilance (QPPV)” is commonly used in European contexts, Venezuela requires a similar role to ensure medicine safety monitoring.

Normative Documents:

Law on Medicaments (Ley de Medicamentos): This law provides the legal framework for health-related matters in Venezuela, including the regulation of pharmaceuticals and the establishment of pharmacovigilance activities.
Resolution NUMBER-0010-9921 (September 1999): Issued by the Ministry of Health and Social Development, this resolution outlines the procedures for obtaining health registrations and the responsibilities of pharmaceutical companies, including aspects related to pharmacovigilance.

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Vietnam

NCA: Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH).

QPPV/LQPPV/LCPPV Requirements: Vietnam mandates that Marketing Authorization Holders (MAHs) establish a pharmacovigilance system and appoint a local qualified person responsible for pharmacovigilance activities. This individual is accountable for monitoring, detecting, and reporting adverse drug reactions (ADRs) to the DAV. The responsibilities align with those of a Qualified Person for Pharmacovigilance (QPPV) as recognized internationally.

Normative Documents:

Law on Pharmacy No. 105/2016/QH13: Effective from January 1, 2017, this law provides the state policy on pharmacy and the development of the pharmaceutical industry, including provisions related to pharmacovigilance and drug quality management.
Circular No. 08/2022/TT-BYT: Issued on September 5, 2022, and effective from October 20, 2022, this circular provides guidelines on human drug registration, including requirements for clinical data, registration processes, and pharmacovigilance obligations for MAHs.
National Pharmacovigilance Guidelines: These guidelines outline the procedures for monitoring, detecting, and reporting ADRs, as well as the responsibilities of healthcare professionals and MAHs in ensuring drug safety.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Yemen

Yemen

NCA: Supreme Board of Drugs and Medical Appliances (SBDMA) under the Ministry of Public Health and Population (MPHP).

QPPV/LQPPV/LCPPV Requirements: Yemen’s pharmacovigilance system is in the early stages of development. Currently, there is no explicit requirement for a Qualified Person for Pharmacovigilance (QPPV) or equivalent roles. However, the SBDMA emphasizes the importance of adverse drug reaction (ADR) reporting and encourages healthcare professionals and pharmaceutical companies to participate in pharmacovigilance activities.

Normative Documents:

National Pharmacovigilance Program (NPP): Yemen has initiated an NPP to monitor the safety of medicines, though its coverage and ADR reporting are currently limited.
Medicines and Medical Appliances Law: Governs the regulation of pharmaceuticals and medical devices in Yemen, including aspects related to pharmacovigilance.

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Zambia, Zimbabwe

Zambia

NCA: Zambia Medicines Regulatory Authority (ZAMRA)

QPPV/LQPPV/LCPPV Requirements: Zambia mandates that Marketing Authorization Holders (MAHs) establish a pharmacovigilance system and appoint a qualified person responsible for pharmacovigilance activities. This individual is accountable for the collection, assessment, and reporting of adverse drug reactions (ADRs) to ZAMRA. While the term “Qualified Person for Pharmacovigilance (QPPV)” is commonly used in European contexts, ZAMRA requires a similar role to ensure medicine safety monitoring.

Normative Documents:

Medicines and Allied Substances Act, 2013: This act provides the legal framework for the regulation of medicines and allied substances in Zambia, including provisions related to pharmacovigilance.
Guidelines for Detecting and Reporting Adverse Drug or Vaccine Reactions and Events: These guidelines outline the procedures for healthcare professionals and MAHs to detect and report ADRs, ensuring compliance with ZAMRA’s pharmacovigilance requirements.

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Zimbabwe

NCA: Medicines Control Authority of Zimbabwe (MCAZ)

QPPV/LQPPV/LCPPV Requirements: Marketing Authorization Holders (MAHs) in Zimbabwe are required to establish a pharmacovigilance system and appoint a Qualified Person for Pharmacovigilance (QPPV) or an equivalent responsible person. This individual is accountable for the collection, assessment, and reporting of adverse drug reactions (ADRs) to MCAZ. The QPPV must be appropriately qualified and experienced in pharmacovigilance activities.

Normative Documents:

Pharmacovigilance Guideline for Pharmaceutical Industry (MCAZ/PVCT/GL-02, Rev 2, May 2024): This guideline provides detailed requirements for MAHs regarding the establishment and maintenance of pharmacovigilance systems, including the roles and responsibilities of the QPPV.
Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition (2016): This handbook outlines the national framework for pharmacovigilance activities, emphasizing the importance of medicine safety and the roles of various stakeholders in the healthcare system.

NOTE: Pharmacovigilance regulations are constantly evolving: It’s crucial to consult the latest official guidance from PharmExpert Team for the most up-to-date information.

Pharmacovigilance QPPV, LQPPV, LCPPV Guide – All Countries

Comprehensive QPPV, LQPPV, LCPPV Requirements Guide 2024-2025: Global Pharmacovigilance Insights for 195 Countries (from A to Z)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «A» (Afghanistan, Albania,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «B» (Bahamas, Bahrain,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «C» (Cabo Verde, Cambodia,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Denmark, Djibouti, Dominica, Dominican Republic

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «E» (East Timor, Ecuador,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Fiji, Finland, France

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «G» (Gabon, Gambia,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Haiti, Honduras, Hungary

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Jamaica, Japan, Jordan

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «K» (Kazakhstan, Kenya,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «L» (Laos, Latvia,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «M» (Madagascar, Malawi,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «N» (Namibia, Nauru,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Oman

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «P» (Pakistan, Palau,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Qatar

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Romania, Russia, Rwanda

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «S» (Saint Kitts and Nevis, Saint Lucia,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «T» (Taiwan, Tajikistan,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Countries beginning with «U» (Uganda, Ukraine,..)

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Vanuatu, Venezuela, Vietnam

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Yemen

Pharmacovigilance QPPV/LQPPV/LCPPV Guide: Zambia, Zimbabwe

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