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...
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...
