News

Following the amended Variations Regulation No 1234/2008 (amended by Commission Delegated Regulation (EU) 2024/1701) applicable since 1 January 2025, the European Commission has now published a draft version of the new...

Dear Clients! Please, be informed that the Regulation of the Cabinet of Ministers No. 895 “Price List of Paid Services of the State Agency of Medicines” (hereinafter – Price list) was adopted on 18 December 2024. The...

Please be advised that the amended Variations Regulation No 1234/2008 (amended by Commission Delegated Regulation (EU) 2024/1701) enter into force on 1 January 2025. Key changes concerning the preparation of variation...

We would like to inform you that on July 23, 2024, amendments to Cabinet Regulation No. 803 of 25 October 2005 "Regulations Regarding the Principles of Pricing of Medicinal Products" (hereinafter - the Amendments) were...

Information for marketing authorisation holders The State Agency of Medicines (SAM) has published documents translated into English, which refer to the submission and approval of Risk minimization educational materials...

The main change to the updated Best Practice Guide (BPG) document (Rev. 5) is to reflect the success of the Multilingual Packaging pilot which took place 2020-2024. To improve the availability of medicinal products in...

The State Agency of Medicines has published its Annual Report of the year 2023 which summarizes information regarding the operation of the Agency during the previous year. Some of the numbers that show Agency’s...

The State Agency of Medicines has developed an online form for notification of contact details of the national level contact person for pharmacovigilance issues to speed up and facilitate this process for marketing...

Dear marketing authorisation holders, Taking into account questions and comments received from marketing authorisation holders' (MAH) for indication of correct last revision date in product information within variation...