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 Medicines Agency if the change concerns a marketing authorisation that we have granted.
Human and veterinary
Guideline on variations to marketing authorisations for medicinal products
Obligations regarding updates of Active Substance Master Files (ASMF/DMF)
Information on EDQM's procedure for withdrawal or suspension of Certificates of Suitability
Requirements for marketing authorisation holders for medicinal products containing active substances in the form of mesilates, (di)isetionates, tosilates or besilates
Temporary repackaging of medicines with a marketing authorisation
Forms
CMD
Human
CMD(h) Examples for acceptable and not acceptable groupings for MRP/DCP products
CMD(h): Q/A-list for the submission of variations
Veterinary
Human and veterinary
Request to CMD for a recommendation on the classification of an unforeseen variation under Article 5 (PDF file)
Request to CMD for a recommendation on the classification of an unforeseen variation under Article 5 (Word)
Questions and answers
The Danish Medicines Agency's questions and answers on variations
Invoices in connection with variation applications
Invoices in connection with variation applications (national and MRP procedures)