Changing the (invented) name of a veterinary medicine

Guidance is available from the European Medicines Agency (EMA) on changing the name of a veterinary medicinal product in the form of questions and answers (Q&As). The Q&As provide an overview of the 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.

Applicants should use the eSubmission Gateway / Web Client for all veterinary post-authorisation procedural submissions submitted to EMA. For more information, including links to guidance on registration with the system see the Veterinary eSubmission website.

A medicinal product is authorised under the centralised procedure with a single name. In accordance with the Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council , the (invented) name of a medicinal product may be changed and needs to be notified within 30 days after implementation of the change via a variation not requiring assessment (classification A.2).

This can be done either in case of a marketing authorisation being granted under INN name (common name) together with a trademark or the name of the MAH, or in case the MAH wants to change the initial invented name.

Such a variation not requiring assessment is possible provided that the check by the Agency on the acceptability of the new name has been finalised and was positive before implementation of the new name. Within 30 days after implementation of the change, the MAH must submit a variation not requiring assessment (A.2) application to the Agency for review.

References

The checking procedure for the proposed invented name is mandatory and is the same as that applied for new medicinal product applications, as described in the Agency pre-submission guidance (see 2.1.2 “How shall I compose the name of my veterinary medicinal product?”).

Therefore, MAHs are advised to submit the new proposed invented name at the latest 4-6 months prior to their intended implementation of the new name since a final positive outcome of the checking procedure is required before implementation and subsequent submission of the variation not requiring assessment (classification A.2).

In order to enable applicants to propose names that will be acceptable for centrally approved medicinal products, it is crucial that the Guideline on the acceptability of names for veterinary medicinal products processes through the centralised procedure is followed.

References

The application will require a variation not requiring assessment (classification A.2) incl. the related dossier requirements (see the Q&A on variations not requiring assessment “When do I have to submit revised product information? In all languages?”). The supporting documentation required and the conditions are defined under classification A.2 in Commission Implementing Regulation (EU) 2021/17. The copy of the Agency’s letter of acceptance of the new name should be submitted in a VNeeS file with the variation not requiring assessment for inclusion in Part 1 of the dossier.

Variations not requiring assessment have to be submitted directly through the Union Product Database. (https://www.medicinesinfo.eu/en) Applicants should use the eSubmission Gateway / Web Client for all other veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see the Veterinary eSubmission website.

References

It is not required to provide mock-ups with the variation application.

Where the overall design and readability of the outer and immediate packaging and/or package leaflet is affected, the Agency may request the applicant to provide specimens and mock-ups on a case-by-case basis.

References

Q&A: Mock-ups

Changing the (invented) name of a veterinary medicine

Related content

Topics

How useful was this page?