On 16 August 2025, amendments to Cabinet Regulation No. 376 of 9 May 2006, “Procedures for the Registration of Medicinal Products,” adopted on 12 August 2025, entered into force.
The amendments are intended to simplify the issuance of marketing authorization certificates by providing them in electronic document format via publication on the website of the State Agency of Medicines (SAM).
Specifically, within three working days after a decision on the marketing authorization or renewal of a medicinal product, as well as after the approval of any variations affecting the information in the marketing authorisation certificate — the SAM will publish the marketing authorisation certificate in the Medicinal Product Register on its website under the relevant product entry.
This new procedure will allow marketing authorisation holders to obtain the current marketing authorisation certificate from the SAM website at any time and will reduce the administrative burden within the SAM.
In addition, these amendments specify the decision-making timeframe for generic marketing authorisation applications submitted under the national registration procedure.
The full text of the amendments is available here.
