The “Analytical Expertise Center” Public Legal Entity of the Ministry of Health of the Republic of Azerbaijan (hereinafter referred to as the Authority), provides information on the list determining the periods and frequency of submission of Periodic Safety Update Reports (PSURs) of medicinal products that have passed state registration in the Azerbaijan Republic.
The “Regulations of the Pharmacovigilance of Medicinal Products” (hereinafter referred to as the Regulations), approved by Decision No. 503 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, was amended by Decision No. 166 of the Cabinet of Ministers of the Republic of Azerbaijan dated March 18, 2024.
You can familiarize yourself with the amendments made to the Regulations by following the link https://e-qanun.az/framework/44069 on the Unified Electronic Database of Legal Acts of the Ministry of Justice of the Republic of Azerbaijan.
Based on the requirements stipulated in subparagraph 16.2.8 of the Regulations, you can find the periods and frequency of submission of PSURs to the Authority in accordance with the “List of EU Reference Dates and frequency of submission of Periodic Safety Update Reports” for medicinal products, the date of their first state registration in the Azerbaijan Republic, or the international registration date of the medicinal product. This information can be obtained by downloading the Excel document from the below provided link.
(Download Excel file Version No. 4 dated August 14, 2024).
Note: If you have any questions regarding the periods and frequency of PSUR submission to the Authority, you can submit a substantiated official request to the “Bir pəncərə” (Single Window) sector of the Authority.
At the same time, we inform you that if no substantiated official request is made by September 1, 2024, regarding the periods and frequency of PSUR submission to the Authority, the information provided in the table will be considered the basis.
We inform you that if the marketing authorization holders (MAH) do not comply with the requirements of the Regulations in a timely and proper manner, the Authority has the right to take measures in accordance with subparagraphs 19.6 and 19.7 of the Regulations. According to the requirements of these subparagraphs, if non-compliance with the provisions of these Regulations is detected when assessing the compliance of the pharmacovigilance system of the MAH with Good Pharmacovigilance Practice (GVP), the Authority immediately informs the Ministry of Health about such non-compliance. Depending on the nature of the non-compliance specified in subparagraph 19.6 of these Regulations, the Ministry sets a period of not less than 15 (fifteen) days and not more than 3 (three) months for the MAH to eliminate the non-compliance. If the non-compliance is not eliminated within this period and the required documents are not submitted, the state registration of the medicinal product is cancelled.
