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...

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...

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 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...

Please note that starting from 22 December 2022 the State Agency of Medicines has made changes in the Medicinal Product Register relating to the format of the published approved package leaflets and summaries of product...

The results of the survey conducted by the State Agency of Medicines (SAM) show that for medicines utilised in hospitals and other healthcare institutions electronic package leaflets are mostly used. Survey results are...

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...

The State Agency of Medicines kindly informs that on 19 October 2022 from 9 am until 11 am the homepage of the Agency may not work (5 - 15 minutes) due to planned technical works. We apologize for the inconvenience!