Q&A: Changing the (Invented) Name of a Centrally Authorised Medicinal Product

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Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “Post-Authorisation Procedures”.

This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.

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1. Can I change the (Invented) Name of my CAP? Rev. July 2015

A medicinal product is authorised under the Centralised Procedure with a single name. In accordance with Commission Regulation (EC) No 1234/2008, the (invented) name of a medicinal product may be changed after authorisation through a Type IAIN Variation (No 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 Type IAIN variation is possible provided that the check by the Agency on the acceptability of the new name had been finalised and was positive before implementation of the new name. Immediately upon implementation of the change, the MAH must submit a Type IAIN variation application to the Agency for review.

References

2. Is the Invented Name (IN) checking procedure mandatory for the new proposed IN?

The checking procedure for the proposed IN is mandatory and is the same as that applied for new medicinal product applications, as described in the Agency pre-submission guidance (see also  “How will I know if the proposed (trade) name of my medicinal product is acceptable from a public health point of view?”).

Therefore, Marketing Authorisation Holders are advised to submit the new proposed IN at the latest 4-6 months prior to their intended implementation of the new name and Type IAIN variation application since a final positive outcome of the checking procedure is required before implementation and submission of the Type IAIN Variation.

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” (EMEA/CVMP/328/98), is followed.

References

3. How shall I present my IN change application?

The application will follow the standard type IA variation dossier requirements as described in this guidance: See “How shall I present my Type IA Variation Application”. The MAH is therefore requested to provide:

  • Cover letter
  • Variation Application form with the following attachments:
    • A copy of the relevant page(s) of the Classification Guideline. As requested in the application form, MAHs must tick the boxes in front of each condition and required documentation. It is recommended to add a reference to the location of each required document in the submitted dossier (e.g. ‘Appendix 1’, ‘Appendix 2’…).
    • A copy of the Agency’s letter of acceptance of the new name.
    • Product information (Summary of Product Characteristics, Annex II, Labelling and Package Leaflet): see “Type I variations - When do I have to submit revised product information? In all languages?”.

One electronic copy of the application should be sent to the Agency vet.applications@ema.europa.eu, as well as to the Rapporteur at the time of submission.

References

4. Do I need to submit amended mock-ups with my variation?

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 need for the provision of mock-ups should be discussed with the Agency on a case-by-case basis.

References

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