Application for variations
Variation means any change to the terms of an authorisation to market a medicinal product as well as any change to the summary of product characteristics and the documents forming the basis for a marketing authorisation.
Different variation systems exist for medicinal products for human use and medicinal products for animal use, respectively.
The variation system for medicinal products for human use is described in Commission Regulation (EC) No. 1334/2008 of 24 November 2008 as amended.
The variation system for medicinal products for animal use is described in articles 60-68 in the Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products.
Both regulations are supported by further information, guidelines, Q&A etc.
In general
Variation application forms
Danish Medicines Agency Q&A on variations
Danish Medicines Agency Information on temporary repackaging of medicines with a marketing authorisation
Danish Medicines Agency Information on obligations regarding updates of Active Substance Master Files (ASMF/DMF)
Danish Medicines Agency Information on EDQM's procedure for withdrawal or suspension of Certificates of Suitability-
Danish Medicines Agency Information on requirements for marketing authorisation holders for medicinal products containing active substances in the form of mesilates, (di)isetionates, tosilates or besilate
Danish Medicines Agency Guidance for companies on fees (including information on definition of complex type II and VRA variation, respectively)
Danish Medicines Agency Information on fees for variation applications (national and MRP procedures)
Medicine for human use
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
Amending (3 August 2012) 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
Amending (24 March 2021) 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
Amending (11 March 2024) 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
European Commission Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of 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 and on the documentation to be submitted pursuant to those procedures
Addendum (7 June 2021) to the European Commission Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of 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 and on the documentation to be submitted pursuant to those procedures
CMDh Best Practice Guides for the submission and processing of variations in the mutual recognition procedure
EMA-CMDh Explanatory notes on variation application form
CMDh Examples for acceptable and not acceptable groupings for MRP/DCP products
CMDh Q&A on variations
CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
CMDh Request form for a recommendation on the classification of an unforeseen variation - Article 5 (pdf)
CMDh Request form for a recommendation on the classification of an unforeseen variation - Article 5 (word)
National Guideline on variations to marketing authorisations for medicinal products for human use
Medicine for animal use
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products
CMDv Best Practice Guides for the submission and processing of variations in the mutual recognition procedure
Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
CMDv Best Practice Guide for variations not requiring assessment
EMA-CMDv Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
CMDv Best practice guide for variations requiring assessment
CMDv Best practice guide for re-examination of RMS assessment report procedure
CMDv Request form for re-examination of RMS assessment report
CMDv Q&A on variations
CMDv Q&A on QP-declarations
EMA-CMDv Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62
CMDv Request form for a recommendation on the classification of a not already listed variation
CMDv Best Practice Guide for Worksharing
CMDv Template for Letter of Intent (LoI) for the submission of a worksharing procedure
CMDv Template for Letter of intent (LoI) for the submission of a VNRA supergrouping
National Guideline on variations to marketing authorisations for medicinal products for animal use
Danish Medicines Agency Q&A about the naming of medicines