Application for variations

Updated 08 September 2023

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  

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

Commission Implementing Regulation (EU) 2023/997 of 23 May 2023 amending 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

National Guideline on variations to marketing authorisations for medicinal products for animal use
 
Danish Medicines Agency Q&A about the naming of medicines