Pharmacovigilance Regulatory Requirements
National Competent Authorities (NCAs) are responsible for overseeing, regulating, and enforcing compliance with established local pharmacovigilance requirements.
National Competent Authority:
The Analytical Expertise Center of the Ministry of Health of the Republic of Azerbaijan
NCA website: www.pharma.az
Azerbaijan pharmacovigilance guidelines:
1.Resolution N503, 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 Regulatory Requirements in Azerbaijan
| 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 |
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/
Belarus pharmacovigilance guidelines:
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 Regulatory Requirements in Belarus
| 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 |
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/
Georgia pharmacovigilance guidelines:
Law of Georgia on Medicines and Pharmaceutical Activities, No 1586 of 10 August 2009
Pharmacovigilance Regulatory Requirements in Georgia
| 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 |
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/
Kazakhstan pharmacovigilance guidelines:
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 Regulatory Requirements in Kazakhstan
| 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 |
National Competent Authority:
Department of Medicines and Medical Devices of the Ministry of Health of the Kyrgyz Republic
NCA website: https://pharm.kg/
Kyrgyzstan pharmacovigilance guidelines:
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 Regulatory Requirements in Kyrgyzstan
| 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 |
National Competent Authority:
Russian Federation Federal Service for Surveillance in Healthcare
NCA website: https://roszdravnadzor.gov.ru/
Russia pharmacovigilance guidelines:
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 Regulatory Requirements in Russia
| 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 |
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/
Tajikistan pharmacovigilance guidelines:
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 Regulatory Requirements in Tajikistan
| 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 |
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
Turkmenistan pharmacovigilance guidelines:
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 Regulatory Requirements in Turkmenistan
| 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 |
National Competent Authority: The State Expert Center of the Ministry of Health of Ukraine
NCA website: https://dec.gov.ua
Ukraine pharmacovigilance guidelines:
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 Regulatory Requirements in Ukraine
| 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 |
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/
Uzbekistan pharmacovigilance guidelines:
Order No. 13 of the Minister of Health of Uzbekistan dated March 9, 2018
Pharmacovigilance Regulatory Requirements in Uzbekistan
| 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 |
