The Decision No. 503 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, the “Regulations on pharmacovigilance of medicinal products” (hereinafter referred to as the Regulations) were approved. After the state registration of a medicinal product, marketing authorization holders (MAH) are required to submit the following documents to the Analytical Expertise Center for pharmacovigilance evaluation and safety monitoring of the medicinal product, as outlined in paragraph 7.1.2 of the Regulations:
- Periodic Safety Update Report (PSUR) — According to the List (specifying submission deadlines and frequency) prepared in line with Sections 16.2.8 and 16.2.8.1 of the Rules, available on the Analytical Expertise Center’s official website: (https://pharma.az/en/uncategorized-en/attention-holders-of-the-registration-certificate-of-medicines/).
- Risk Management Plan (RMP) — As required by paragraph 16.2.7 of the Regulations and paragraph 7.3 of the Good Pharmacovigilance Practice guidelines.
- Pharmacovigilance system master file (PSMF) — According to paragraph 7.1.13 of the Regulations, the MAHs must submit the Pharmacovigilance System Master File to the Analytical Expertise Center within 7 (seven) working days upon request.
Additionally, we inform you that the Tariff Council of the Republic of Azerbaijan, in its Decision No. 10 dated December 5, 2023, has approved the tariffs for expert services related to pharmacovigilance documents submitted after the state registration of a medicinal product, which will enter into force on May 1, 2025 (https://pharma.az/tarifler/tarifl-r/).
Please note that if the MAHs do not comply with the requirements of the Regulations in a timely and proper manner, the Analytical Expertise Center has the authority to take measures in accordance with paragraphs 19.6 and 19.7 of the Regulations. In case of non-compliance with the requirements and if a violation is detected, the Ministry of Health will be immediately informed about this fact. Depending on the nature of the violation, the Ministry will set a period of no less than 15 (fifteen) days and no more than 3 (three) months for the resolution of the violation. If the violation is not resolved and the required documents are not provided within the specified time, the state registration of the medicinal product will be revoked.
