As of 16 August, Marketing Authorization Certificates are published on the SAM website
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...
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