Pharmacovigilance Requirements
Pharmacovigilance requirements are standards and rules that ensure the safety, efficacy and quality of medicinal products. They are aimed at monitoring, analyzing and preventing side effects or other risks associated with the use of medicines. The introduction and compliance with these requirements is an important part of the regulation of the pharmaceutical industry at the national and international level.
Azerbaijan Pharmacovigilance Guideline
National Competent Authority:
The Analytical Expertise Center of the Ministry of Health of the Republic of Azerbaijan
NCA website::http://www.pharma.az/
Normative Documents:
1.Resolution N 503, 25.12.2019 on the approval of Regulation of the pharmacovigilance of medicinal products
2.Resolution № 39, 25.08.2020 on approval of the “Guidelines for Good Pharmacovigilance Practice”
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | Yes |
| Qualified Person for Pharmacovigilance (QPPV) | Yes |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | Yes |
| Weekly local/global Regulatory intelligence monitoring | Yes |
| Routine PSUR/PBRER/DSUR submission | Yes |
| RMP submission | Yes |
| Local/global Signal detection | Yes |
| Risk Minimization Measures (RMM) | Yes |
| Additional Risk Minimization Measures (aRMM) | Yes |
Belarus Pharmacovigilance Guideline
National Competent Authority:
Center for Expertise and Testing in Healthcare under the Ministry of Health of the Republic of Belarus
NCA website: https://www.rceth.by/
Normative Documents:
1. Decision No. 81 of the Council of the Eurasian Economic Commission “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union”
2. Resolution No. 48 of the Ministry of Health of the Republic of Belarus “On Approval of the Instructions on the Procedure for Submitting Information on Identified Adverse Reactions to Medicines and Recognizing Certain Resolutions of the Ministry of Health of the Republic of Belarus as Invalid” (as amended on 23.10.2020 No. 87)
3. Law of the Republic of Belarus “On Circulation of Medicines” (as amended on 14.10.2022 No. 213Z)
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | Yes |
| Qualified Person for Pharmacovigilance (QPPV) | Yes |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | Yes |
| Weekly local/global Regulatory intelligence monitoring | Yes |
| Routine PSUR/PBRER/DSUR submission | Yes |
| RMP submission | Yes |
| Local/global Signal detection | Yes |
| Risk Minimization Measures (RMM) | Yes |
| Additional Risk Minimization Measures (aRMM) | Yes |
Georgia Pharmacovigilance Guideline
National Competent Authority:
State Regulation Agency for Medical Activities under the Ministry of Labour, Health and Social Affairs of Georgia
NCA website: http://www.rama.moh.gov.ge/
Normative Documents:
Law of Georgia on Medicines and Pharmaceutical Activities, No 1586 of 10 August 2009
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | No |
| Qualified Person for Pharmacovigilance (QPPV) | No |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | No |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | No |
| Weekly local/global Regulatory intelligence monitoring | No |
| Routine PSUR/PBRER/DSUR submission | No |
| RMP submission | No |
| Local/global Signal detection | No |
| Risk Minimization Measures (RMM) | No |
| Additional Risk Minimization Measures (aRMM) | No |
Russia Pharmacovigilance Guideline
National Competent Authority:
Russian Federation Federal Service for Surveillance in Healthcare
NCA website: https://roszdravnadzor.gov.ru/
Normative Documents:
1. Federal Law No. 61 of 12.04.2010 -FZ “On the Circulation of Medicines”
2. Order of Roszdravnadzor No. 1071 of 15.02.2017 “On approval of the procedure for implementing pharmacovigilance”
3. The rules of Good Pharmacovigilance Practice (GVP), approved by the Decision of the Council of the Eurasian Economic Commission of 03.11. 2016 No. 87 (GVP EAEU)
4. Order of the Ministry of Health of Russia dated 07.09.2015 No. 5539 “On approval of the procedure for implementing selective quality control of medicines for medical use”
5. Agreement on uniform principles and rules for the circulation of medicines within the Eurasian Economic Union.
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | Yes |
| Qualified Person for Pharmacovigilance (QPPV) | Yes |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | Yes |
| Weekly local/global Regulatory intelligence monitoring | Yes |
| Routine PSUR/PBRER/DSUR submission | Yes |
| RMP submission | Yes |
| Local/global Signal detection | Yes |
| Risk Minimization Measures (RMM) | Yes |
| Additional Risk Minimization Measures (aRMM) | Yes |
Kazakhstan Pharmacovigilance Guideline
National Competent Authority:
National Center for Expertise of Medicines and Medical Devices of the Ministry of Health of the Republic of Kazakhstan
NCA website: https://www.ndda.kz/
Normative Documents:
1.Code of the Republic Of Kazakhstan On Public Health And The Healthcare System (with amendments and additions as of 07.07.2020)
2.Decision No. 87 of November 3, 2016 “On approval of the Rules of good pharmacovigilance practice of the Eurasian Economic Union”
3.Order of the Minister of Health of the Republic of Kazakhstan dated December 23, 2020 No. KR DSM-320/2020. “On approval of the rules for conducting pharmacovigilance and monitoring the safety, quality and efficacy of medical devices”
4.Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-10 “On approval of the rules for conducting examination of medicines and medical devices”
5.Order of the Acting Minister of Health of the Republic of Kazakhstan dated February 4, 2021 No. KR DSM-15 “On approval of good pharmaceutical practices”
6.Order of the Minister of Health of the Republic of Kazakhstan dated September 10, 2020 No. KR DSM-101/2020 “On approval of the Rules for drafting and formalizing instructions for medical use of medicines and medical devices and general characteristics of the medicine”
7.Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-9 “On approval of the rules for conducting pharmaceutical inspections for good pharmaceutical practices”
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | Yes |
| Qualified Person for Pharmacovigilance (QPPV) | Yes |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | Yes |
| Weekly local/global Regulatory intelligence monitoring | Yes |
| Routine PSUR/PBRER/DSUR submission | Yes |
| RMP submission | Yes |
| Local/global Signal detection | Yes |
| Risk Minimization Measures (RMM) | Yes |
| Additional Risk Minimization Measures (aRMM) | Yes |
Kyrgyzstan Pharmacovigilance Guideline
National Competent Authority:
Department of Medicines and Medical Devices of the Ministry of Health of the Kyrgyz Republic
NCA website: https://pharm.kg/
Normative Documents:
1.On approval of the Procedure for conducting pharmacovigilance No. 546 dated 09/06/2024
2.Order No. 1073 dated 10/03/2024 On the implementation of the Resolution of the Cabinet of Ministers of the Kyrgyz Republic “On approval of the Procedure for conducting pharmacovigilance” No. 546 dated 09/06/2024
3.Law of the Kyrgyz Republic “On circulation of medicines” No. 13 dated 01/12/2024
4.On amendments to the Rules of good pharmacovigilance practice of the Eurasian Economic Union 05/19/2022 No. 81
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | Yes |
| Qualified Person for Pharmacovigilance (QPPV) | Yes |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | Yes |
| Weekly local/global Regulatory intelligence monitoring | Yes |
| Routine PSUR/PBRER/DSUR submission | Yes |
| RMP submission | Yes |
| Local/global Signal detection | Yes |
| Risk Minimization Measures (RMM) | Yes |
| Additional Risk Minimization Measures (aRMM) | Yes |
Tajikistan Pharmacovigilance Guideline
National Competent Authority:
Ministry of Health and Social Protection of the Population of the Republic of Tajikistan
State Supervision Service for Health Care and Social Protection of the Population.
NCA website: https://moh.tj/
Normative Documents:
1.The Law of the Republic Tajikistan on Medicines, Medical Products and Pharmaceutical ХCT №82 01.03.2022
2. Order № 197 dated March 4, 2021 On execution of point 18 of part 1 of article 6 and article 29 of the Law of the Republic of Tajikistan “About medicines and pharmaceutical activity”.
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | No |
| Qualified Person for Pharmacovigilance (QPPV) | No |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | No |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | No |
| Weekly local/global Regulatory intelligence monitoring | No |
| Routine PSUR/PBRER/DSUR submission | Yes |
| RMP submission | No |
| Local/global Signal detection | No |
| Risk Minimization Measures (RMM) | No |
| Additional Risk Minimization Measures (aRMM) | No |
Turkmenistan Pharmacovigilance Guideline
National Competent Authority:
Center for Registration of Medicinal Products and State Control of their Quality under the Ministry of Health and Medical Industry of Turkmenistan
NCA website: https://centreg.gov.tm
Normative Documents:
1. Law of Turkmenistan on drug provision,12 January 2023.
2. No. 320 Order “On the procedure for monitoring side effects of medicines”, 05 October 2017
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | No |
| Qualified Person for Pharmacovigilance (QPPV) | No |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | No |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | No |
| Weekly local/global Regulatory intelligence monitoring | No |
| Routine PSUR/PBRER/DSUR submission | No |
| RMP submission | No |
| Local/global Signal detection | No |
| Risk Minimization Measures (RMM) | No |
| Additional Risk Minimization Measures (aRMM) | No |
Ukraine Pharmacovigilance Guideline
National Competent Authority: The State Expert Center of the Ministry of Health of Ukraine
NCA website: https://dec.gov.ua
Normative Documents:
1. On the approval of the Procedure for conducting pharmacovigilance, order of the Ministry of Health of Ukraine, dated December 27, 2006 N 898
2. Order of the Ministry of Health of Ukraine dated August 26, 2005 No. 426 (On approval of the Procedure for conducting examination of registration materials for medicinal products submitted for state registration (re-registration), as well as examination of materials on making changes to registration materials during the validity of the registration certificate as amended by the order of the Ministry of Health of Ukraine dated July 23, 2015 No. 460)
3. On the approval of the Procedure for the termination of the registration certificate for a medicinal product and the Regulation on the Commission of the Ministry of Health of Ukraine on the termination of the registration certificate for a medicinal product, order of the Ministry of Health of Ukraine on August 5, 2020 N1801
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | Yes |
| Qualified Person for Pharmacovigilance (QPPV) | Yes |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | Yes |
| Weekly local/global Regulatory intelligence monitoring | Yes |
| Routine PSUR/PBRER/DSUR submission | Yes |
| RMP submission | Yes |
| Local/global Signal detection | Yes |
| Risk Minimization Measures (RMM) | Yes |
| Additional Risk Minimization Measures (aRMM) | Yes |
Uzbekistan Pharmacovigilance Guideline
National Competent Authority:
The Center for Pharmaceutical Products Safety under the Ministry of Health of the Republic of Uzbekistan
NCA website: https://www.uzpharm-control.uz/
Normative Documents:
Order No. 13 of the Minister of Health of Uzbekistan dated March 9, 2018
Pharmacovigilance Requirements
| MAH responsibility | Requirement |
| Pharmacovigilance System Master File (PSMF) | No |
| Qualified Person for Pharmacovigilance (QPPV) | Yes |
| Local QPPV/Local Contact Person for Pharmacovigilance (LCPPV) | Yes |
| Adverse Event reporting | Yes |
| Weekly local/global literature surveillance | No |
| Weekly local/global Regulatory intelligence monitoring | No |
| Routine PSUR/PBRER/DSUR submission | No |
| RMP submission | No |
| Local/global Signal detection | No |
| Risk Minimization Measures (RMM) | No |
| Additional Risk Minimization Measures (aRMM) | No |
