This page lists questions that marketing-authorisation holders (MAHs) may have on changing the name of a medicine. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available:

 

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

Reference Number: EMEA-H-19984/03 Rev. 107

English (EN) (2.63 MB - PDF)

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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

Reference Number: EMEA-H-19984/03 Rev. 107

English (EN) (2.65 MB - PDF)

First published: Last updated:
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These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

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 (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 notification to the Agency for review (see PAG on Type IA variations).

References

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 IAINVariation.

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 invented names for human medicinal products processes through the centralised procedure is followed.

References

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 Notification”. The MAH is therefore requested to provide:

  • Module 1.0
    a. Cover letter
  • Module 1.2
  • b. Electronic Variation Application Form with the following attachments:
  • c. A copy of the relevant page(s) of the annex to the Variations Guidelines. 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'…).
  • d. A copy of the Agency's letter of acceptance of the new name
  • Module 1.3
  • e. 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?”

More information is available on 'Submitting a post-authorisation application'. 

References

For information concerning submission of mock-ups and specimens in the framework of post-authorisation procedures, please refer to Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure, 3.4 other post authorisation procedures.

References

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