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.

A marketing authorisation for a medicine is generally valid for five years. The marketing authorisation holder must apply for a renewal no later than six months before the expiry of the authorisation.

Guidelines

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)

Mutual recognition and decentralised procedure

Human medicines

The EU Commission's Guideline on the processing of renewals in the mutual recognition and decentralised procedures for human medicines (pdf)

Veterinary medicines

The EU Commission's Guideline on the processing of renewals in the mutual recognition and decentralised procedure for veterinary medicines (pdf)

National procedure

Human medicines

Guideline on application for renewal of marketing authorisation for nationally authorised medicinal products for human use

Veterinary medicines

Guideline on application for renewal of marketing authorisation for nationally authorised medicinal products for veterinary use

Parallel import

Guidelines on application for renewal of parallel import marketing authorisation

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Application forms

Application form for renewal of marketing authorisation for nationally authorised medicines (Word format)

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

Human medicines

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

Veterinary medicines

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