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...
Dear clients of the State Agency of Medicines! We are truly grateful for our collaboration and provided annual evaluation of accomplished work made by State Agency of Medicines (Agency). We invite you to provide feedback...
The State Agency of Medicines (SAM) has been able to halve the time of expertise in case of change of marketing authorisation holder (MAH) to allow companies to change the MAH of medicines in a timely manner, thus, being...
