• Jaga
Marketing authorisations
Clinical trials
Handling and brokering of medicinal products
Blood Act
Advertising
Drug Precursors

Marketing authorisations

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. Also needful forms and instructions.

Marketing authorisations - legislation

Name Date of entry
Medicinal Products Act 24.11.2021 View
Conditions and procedure for classification of proprietary medicinal products 24.11.2021 View
Types of and formal requirements for applications for marketing authorisations regarding medicinal products 24.11.2021 View
Terms and procedure for granting and renewing of a marketing authorisation of a medicinal product and handling of an application 24.11.2021 View
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 24.11.2021 View
The Conditions and Procedure for Classifying a Substance or Product as a Medicinal Product 24.11.2021 View
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 24.11.2021 View
Commission Delegated Regulation (EU) No 357/2014 - regards situations in which post-authorisation efficacy studies may be required 24.11.2021 View
Consolidated text: Commission Regulation (EC) No 1234/2008 - the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products 24.11.2021 View
Types of variations to conditions which constitute basis for grant of marketing authorisation, and conditions and procedure for application for variations 24.11.2021 View

Marketing authorisations - forms, instructions

Name Date of entry
Direct Healthcare Professional Communication - DHPC | 759.2 KB | pdf 24.11.2021 Download
Additional risk minimisation measures (aRMM) - submission of educational materials | 94.69 KB | pdf 24.11.2021 Download
Application for sending of medicinal products | 52.43 KB | pdf 25.11.2021 Download
Download all files

Last updated: 24.11.2021

Stay up do date!

Subscribe to the newsletter:

Republic of Estonia Agency of Medicines

  •  Veski 32, 50409 Tartu
  • +372 737 4140
  • info@ravimiamet.ee
  • Open Monday to Friday from 08:30 to 16:00
Cookies Help