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

26 November 2012, Updated 31 August 2016

Human and 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 not later than nine months (human medicinal products) or six months (veterinary medicinal products) before expiry.

Once an authorisation has been renewed, it is valid for an unlimited period of time. However, if the benefit/risk ratio so dictates, the Danish Medicines Agency may decide that an additional 5-year renewal is required.

It is possible to apply for an earlier renewal and for all pharmaceutical forms and strengths of a product at the same time, regardless that some of the related marketing authorisations expire at a later date. On the basis of a concrete evaluation, the Danish Medicines Agency decides whether all pharmaceutical forms and strengths can be renewed for an unlimited period of time.

The renewal fee is charged and invoiced pursuant to the current executive order on fees for medicinal products and pharmaceutical companies (Bekendtgørelse om afgifter for lægemidler og fremstillere af lægemidler, mellemprodukter og råvarer). The fee is payable per D.sp.no. and includes all pharmaceutical forms and strengths of a product, if applied for at the same time.

Please send the application marked "Application for renewal of marketing authorisation" to:

The Danish Medicines Agency
Workflow Section
Axel Heides Gade 1
2300 Copenhagen S
Denmark

Documentation

Documentation should be submitted in accordance with the rules that apply for the Mutual Recognition and Decentralised Procedure, i.e.:

Human medicines

CMDhs Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures for human medicines

Veterinary medicines

CMDvs guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedure for veterinary medicines

Application forms

The European Commission’s Application Form for Renewal of Marketing Authorisation are available on, the Ema's website: esubmission.ema.europa.eu/eaf/

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