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...
