Renewal of a marketing authorisation veterinary medicinal product

A marketing authorisation is in principle valid for a period of five years. The marketing authorisation can be extended after five years, once the benefits and risks of the veterinary medicinal product have again been assessed.

Criteria for extension

National procedure

If your veterinary medicinal product is admitted via the national procedure, an extension of the marketing authorisation for the veterinary medicinal product can be requested after expiry of the first period (5 years).

Applications for the extension of the marketing authorisation must be submitted at the latest 6 months before the expiry deadline of the marketing authorisation.

Applications for the extension of national marketing authorisations are processed in accordance with the deadlines set in the Veterinary Medicinal Products Decree.

MRP or DCP procedure

If your veterinary medicinal product is admitted via the European MRP or DCP procedure, extension of the marketing authorisation for the veterinary medicinal product can be requested after expiry of the first period (5 years).

Applications for the extension of the marketing authorisation must be submitted at the latest 6 months before the expiry deadline of the marketing authorisation.

The procedure is carried out according to the Best Practice Guide for Handling of renewals in Mutual Recognition and Decentralised Procedure, which can be found on the CMDv renewals website.

Centralised procedure

Applications for renewal of Centrally authorised products go through the European Medicines Agency (EMA). The procedure to be followed is described in chapter 4 of the Notice to Applicants. More information can be found in the Guideline on the processing of renewals in the Centralised procedure.

If you would like to submit a centralised application, please consult the EMA website.

Requested documentation

A renewal application for a veterinary medicinal product must be accompanid by the following documents, which should be sent to the MEB Agency, Veterinary Medicinal Products Unit, for national, MRP- or DCP-procedures:

  1. Application form for renewal of a marketing authorisation. This must be completed in full.
  2. The relevant appendices of the application form. These are listed in the Guideline on the processing of renewals in the Mutual Recognition and Decentralised Procedure.
  3. A digital draft SPC/label/package leaflet as a Word file. The digital SPC must be accompanied by draft label and package leaflet texts according to the set Dutch template. For the further completion of the SPC, label and package leaflet, please refer to the CMDv guidelines.
  4. A Good Manufacturing Practice (GMP) declaration, if the manufacturer of the product does not have a Dutch manufacturer's license. If there is a Dutch manufacturer's license, then the GMP status will be checked internally at the Veterinary Medicinal Products Unit.
  5. Reporting of observed adverse effects, with the following appendices::
    • Periodic Safety Update Report (PSUR)
    • Clinical Expert Statement
    • Commitments, if there is a need for further investigation
    • For more information, please see Periodic Safety Update Reports (PSURs).

Application submission

To submit a transfer of market authorisation, you are requested to submit all the above information to the Veterinary Medicines Agency. You can read how to do this on the page Submitting a dossier.