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...
The first cooperation meeting of the Estonian, Latvian, Lithuanian and Polish State Agencies of Medicines was held on the 7 and- 8th of September in Tartu. On the first day, heads of agency's met to discuss common issues...
The objective of the State Agency of Medicines (hereinafter - the Agency) is to work in the public interest so that the population has access to safe and effective medicinal products. In accordance with Sub-paragraph 146...
