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    Marketing authorisations

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    General requirements, rights and obligations of Applicants and Marketing Authorisation Holders are provided in the Medicinal Products Act. The specific conditions, detailed requirements and procedures are provided under Medicinal Products Act in the regulations listed below.

    Direct Healthcare Porfessional Communication (DHPC) - Submission of text and communication plan for approval by SAM (updated 15.09.2021)

    Additional risk minimisation measures (aRMM) - Submission of educational materials(updated 27.02.2019)

    The translations of legislation and regulations published on our web site may not be properly updated and may include provisions which have been amended or declared invalid.