Application for variations

Marketing authorisation holders must apply for authorisation of any change (variation) to the summary of product characteristics and the documents based on which a medicine has been granted a marketing authorisation.

The variation application must be submitted to the Danish Health and Medicines Authority if the change concerns a marketing authorisation that we have granted.

Human and veterinary

Obligations regarding updates of Active Substance Master Files (ASMF/DMF)

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 (PDF file)

The European Commission's guideline on the procedures for the examination of variations under the new variations regulation (PDF file)

The European Commission's guideline on the various categories of variations under the new variations regulation (PDF file)

The European Commission's guideline on the various categories of variations under the new variations regulation (Word file)

Information on EDQM's procedure for withdrawal or suspension of Certificates of Suitability

Temporary repackaging of medicines with a marketing authorisation

Forms 

The European Commission's application form for variation to a marketing authorisation (human and veterinary) (Word file)

European Medicines Agency/CMDh explanatory notes on Variation Application Form (Human medicinal products only) (PDF file)

CMD

Human

CMD(h) best practice guides for the submission and processing of variations in the mutual recognition procedure (PDF file)

CMD(h): Q/A-list for the submission of variations (PDF file)

CMD(h) Examples for acceptable and not acceptable groupings for MRP/DCP products (PDF file)

CMD(h) Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 (Excel file)

Veterinary

CMD(v) best practice guides for the submission and processing of variations in the mutual recognition procedure

Human and veterinary

Request to CMD for a recommendation on the classification of an unforeseen variation under Article 5 (PDF file)   

Questions and answers

The Danish Health and Medicines Authority's questions and answers on variations