Validity of a marketing authorisation (veterinary medicines)
VeterinaryRegulatory and procedural guidance
Guidance is available from the European Medicines Agency (EMA) on the validity of a marketing authorisation for centrally authorised veterinary medicines in the form of questions and answers (Q&As). The Q&As provide an overview of EMA's position on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.
The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) changed rules on the authorisation of veterinary medicines in the EU when it became applicable on 28 January 2022. This includes changes to certain post-authorisation procedures.
Guidance for marketing authorisation holders whose marketing authorisation’s five-year validity period expires on or after 28 January 2022 is available in a notice published by the European Commission. This explains the practical steps they need to take to implement the relevant provisions of the Regulation.
Procedural guidance for centrally authorised veterinary medicinal products based on the European Commission notice is available below.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) provides information to marketing authorisation holders for nationally authorised products: CMDv: Implementation of the VMP Regulation
Questions and answers
The Agency will send you a letter concerning the expiry of the validity of the marketing authorisation. You will need to reply to this letter to confirm whether or not you wish your marketing authorisation to be unlimited in duration upon expiry of its 5-year period of authorisation. If you reply in the affirmative, the European Commission will then take the necessary steps to ensure that the marketing authorisation becomes unlimited in duration. If you reply in the negative or do not reply to the letter from the Agency, the marketing authorisation will automatically expire after the 5-year period of validity.
Alternatively, you could apply for a renewal, under existing legislation, before entry into application of the VMP Regulation1 (see question 2 below).
1The validation date of the renewal application should be before 28 January 2022.
In cases where the expiry of my marketing authorisation after the 5-year period would fall on or after entry into application of the VMP Regulation, can I choose to apply earlier than 6 months before expiry of the marketing authorisation for the renewal of the marketing authorisation for my veterinary medicinal product?
Yes, in consultation with the Agency, it is possible to apply early for a renewal in these circumstances in accordance with Regulation (EC) No 726/2004. Please note that the validation date of the renewal application should fall before 28 January 2022 and that in this case an assessment will be undertaken.
No, there will be no assessment involved in an administrative removal of the 5-year limit for the period of validity, i.e. where no renewal application has been submitted.
In accordance with Article 151 of the VMP Regulation, the renewal request will be dealt with under Regulation (EC) No 726/2004 and the marketing authorisation will remain valid until the end of its validity as stated in the decision granting the marketing authorisation.
The status of your marketing authorisation will remain the same and no further action is required.
If you express your interest in obtaining an unlimited duration of the marketing authorisation for your veterinary medicinal product, the marketing authorisation will remain valid in practice until amendment of the marketing authorisation decision, which will ‘regularise’ the legal situation regarding unlimited duration of that marketing authorisation.
What if there are no upcoming procedures that would necessitate amendment of the decision for the veterinary medicinal product concerned before the expiry date of the marketing authorisation and following the entry into application of Regulation (EU) 2019/6?
If there are no timely upcoming procedures, the European Commission will issue a Decision amending the marketing authorisation at or around the marketing authorisation’s expiry date. If such a Decision is not adopted before the expiry date of the marketing authorisation, the marketing authorisation will remain valid in practice until amendment of the marketing authorisation decision, which will ‘regularise’ the legal situation regarding unlimited duration of that marketing authorisation.
The marketing authorisation would expire naturally at the current date of expiry of the period of validity.
No, no fee will be payable for the administrative removal of the 5-year limit for the period of validity, i.e. where no renewal application has been submitted.