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 [2]
• Conditions and procedure for classification of proprietary medicinal products [3], 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 [4], 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 [5], 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 [6], Ministry of Social Affairs No. 18 of 17 February 2005
• The Conditions and Procedure for Classifying a Substance or Product as a Medicinal Product [7], 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 [8], 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 [9] (updated 15.09.2021)

Additional risk minimisation measures (aRMM) - Submission of educational materials [10](updated 27.02.2019)

• Commission Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required [11]
• Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products [12]
• Types of variations to conditions which constitute basis for grant of marketing authorisation, and conditions and procedure for application for variations [13], Minister of Social Affairs Regulation No. 13 of 26 February 2010 (applicable for transfers of marketing authorisation, herbal medicinal products, homeopathic products, parallel import licences and for variations under Article 61 of 2001/83/EC)

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.