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.
- Medicinal Products Act
- Conditions and procedure for classification of proprietary medicinal products, Minister of Social Affairs Regulation No. 22 of 17 February 2005
- Types of and formal requirements for applications for marketing authorisations regarding medicinal products, the list of supplementary documentation, the requirements for supplementary documentation, the amount of the fee payable for professional assessment of applications by application type, and the procedure for the calculation and payment of the fee, Minister of Social Affairs Regulation No. 28 of 18 February 2005
- Terms and procedure for granting and renewing of a marketing authorisation of a medicinal product and handling of an application, and recognising of the evaluation of a competent institution of a member state of the European Economic Area, Minister of Social Affairs Regulation No. 29 of 18 February 2005
- List of documents subject to submission for licence for parallel import in respect of a medicinal product, and the conditions and procedure for processing of applications, Ministry of Social Affairs No. 18 of 17 February 2005
- The Conditions and Procedure for Classifying a Substance or Product as a Medicinal Product, Minister of Social Affairs Regulation No. 59 of 13 April 2005
- Procedure for providing safety information about medicinal products, for calculating the fees charged for the safety and quality monitoring of medicinal products and for the payment of such fees, Minister of Social Affairs Regulation No. 26 of 16 July 2012
Direct Healthcare Porfessional Communication (DHPC) - Submission of text and communication plan for approval by SAM (updated 21.03.2019)
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.