Application for renewal of marketing authorisation

On this page, you can find guidelines and forms for the renewal of marketing authorisations for human and veterinary medicines and parallel import of medicines.

Human medicines

Pursuant to section 27 of the Danish Medicines Act, a marketing authorisation must be renewed after five years.

The marketing authorisation holder must submit a renewal application at least nine months before the marketing authorisation expires.

The EU Commission's application form for renewal of marketing authorisation for human medicines (Word format)

Veterinary medicines

Pursuant to section 27 of the Danish Medicines Act, a marketing authorisation must be renewed after five years.

The marketing authorisation holder must submit a renewal application at least six months before the marketing authorisation expires.

The EU Commission's application form for renewal of marketing authorisation for veterinary medicines (Word format)

Centralised procedure

Human medicines

The EU Commission's Guideline on the processing of renewals in the centralised procedure for human medicines (PDF)

Veterinary medicines

The EU Commission's Guideline on the processing of renewals in the centralised procedure for veterinary medicines (PDF)

Decentralised procedure and mutual recognition procedure

Human medicines

CMDh's Guideline on the processing of renewals in the mutual recognition and decentralised procedures for human medicines (PDF)

Veterinary medicines

CMDv's Guideline on the processing of renewals in the mutual recognition and decentralised procedure for veterinary medicines (PDF

National procedure

Guideline on application for renewal of marketing authorisation

Parallelimport

Guidelines for application for renewal of parallel import marketing authorisation

Application for renewal of marketing authorisation for parallel import of an already approved medicine (e-form in Danish only)