Formalities to be followed in transferring a marketing authorisation are described below :
Articles R. 5141-40 of the Public Health Code
Content of the declaration
- A letter of request from the current holder specifying the name of the medicinal product and the file number assigned by the ANMV concerned by the transfer, as well as the name, telephone number and email address of the person to be contacted during the procedure (Template MA transfer request);
- A certificate from the current holder that the complete and up-to-date MA dossier for the medicinal product concerned is transferred to the future holder;
- The undertaking of those responsible for manufacturing establishments to comply with the conditions laid down in the marketing authorisation and, in particular, to comply with the methods of manufacture and control;
- A description of the pharmacovigilance device that the future holder intends to put in place;
- An updated draft SPC and labelling for all commercial submissions (and package leaflet if applicable);
- Upon transfer of a ‘sleeping marketing authorisation’ (for veterinary medicinal products listed in Annex IV, as part of the implementation of the Order of 24 January 2001 on animal spongiform encephalopathies), the prospective holder must provide the ANMV with a letter of commitment (Template commitment);
- Documents to be provided in addition where the future holder is not established in France:
- proof that the applicant is established in Europe.
- Where the number of marketing authorisations to be transferred exceeds 10, the applicant for the transfer may:
- enter all transfers by a single general mail including a summary list of all the relevant dossiers (MAs or files under investigation).
- In the case of a merger or partial contribution of assets, interested companies may apply for the transfer of marketing authorisations before the merger or contribution is finally completed. They shall provide, in support of their request, the Memorandum of Understanding in Principle on the merger or contribution. The transfer is granted under the suspensive condition of its final implementation, which shall be notified to the Director-General of Anses;
- The invoice corresponding to the fee for the transfer of marketing authorisation will be sent to the current MA holder;
- The decision must be notified within 60 days of receipt of a complete dossier.
Recipient of the request
The request must be sent by post to:
Anses-French agency for veterinary medicinal products
Département Décisions administratives
14 Rue Claude Bourgelat
Parc d’activités de la Grande Marche — Javené
CS 70611-35306 FOUGERES FRANCE
Contact for information : +33 02 99 94 66 65 - e-mail : email@example.com