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...