Renewal of a marketing authorisation

In most cases, the renewal application will therefore disappear pursuant to the VMPR. Once the application has been approved, a marketing authorisation will be issued immediately for an indefinite period. This marketing authorisation will remain valid for as long as the safety of people, animals and the environment is guaranteed. 

An exception applies to marketing authorisations based on the legal grounds ‘limited markets’ and ‘exceptional circumstances’ (Articles 23 and 25 VMPR). These marketing authorisations are not immediately valid for an indefinite period. 

Transitional provisions for renewal

Under Directive 2001/82/EC, a marketing authorisation for a veterinary medicinal product is valid for five years. This applies to initial applications for authorisation. After five years, these marketing authorisations are converted into authorisations for an unlimited period. This is done through submission of a renewal application.

A number of transitional provisions have been drawn up on the conversion of temporary marketing authorisations into marketing authorisations with an unlimited period of validity. The European Commission has published a notice (2021 /C 274/02) on central and national authorisations whose period of validity will expire on or after 28 January 2022. The EMA has drawn up a list of questions and answers in respect of centrally authorised veterinary medicinal products. The CMDv QA document on transitional arrangements describes the transitional provisions for the mutual recognition procedure (MRP) and decentralised procedure (DCP). These arrangements provide the template for national provisions on how to convert temporary marketing authorisations into authorisations with an unlimited period of validity.

Procedure in the Netherlands

The procedure described below applies to marketing authorisations that were issued via the national procedure, the mutual recognition procedure (MRP) or the decentralised procedure (DCP). A number of situations may occur:

Situation 1

Marketing authorisation granted: before 28 January 2022
Valid until: after 28 January 2022
Deadline for submitting renewal application: before 28 January 2022

• The renewal application must be submitted at least six months before the validity of the marketing authorisation expires;
• Renewal procedures apply to all marketing authorisations for which the renewal application must be submitted before 28 January 2022. These also include marketing authorisations which expire after 28 January 2022.

Situation 2

Marketing authorisation granted: before 28 January 2022
Valid until: after 28 January 2022
Deadline for submitting renewal application: after 28 January 2022

• If the validity of a marketing authorisation expires after 28 January 2022 but the deadline for submitting the renewal application falls after this date as well, the authorisation holder will not be required to submit a renewal application;
• According to the CMDv QA document on transitional arrangements, it is up to the national competent authority to decide how this conversion into a marketing authorisation for an indefinite period is carried out;
• This is what you may expect from us:

- In the Netherlands, marketing authorisations granted for a definite period will from 28 January 2022 be automatically converted into a marketing authorisation for an indefinite period. No action is required on your part;
- You will automatically receive an amended decision;
- A list of all veterinary medicinal products to which this applies will be published in the Government Gazette;
- This procedure is free of charge.

Situation 3

Marketing authorisation granted: after 28 January 2022
Application submitted: before 28 January 2022

• According to the CMDv QA document on transitional arrangements, it is up to the national competent authority to decide how to deal with this situation;
• In the Netherlands, these marketing authorisations will immediately have an indefinite period of validity.

Situation 4

Marketing authorisation granted: before 28 January 2022
Already renewed for an unlimited period of validity before 28 January 2022

• Nothing will change in respect of marketing authorisations that currently have an unlimited period of validity.