For medicinal products with limited marketing authorisation, the original MA has a validity of 5 years. For marketing authorisations in exceptional circumstances they shall be reviewed annually.
Before the expiry of that period, it is for the holder to apply for the renewal of his authorisation (three months before the expiry date for exceptional circumstances and six months before the expiry date for limited contracts).
The application for renewal shall be accompanied by the summary list of documents submitted relating to quality, safety and effectiveness, including all modifications authorised since the issuance of the initial authorisation or the last renewal.
The nature and the documents to be provided when submitting an application for renewal of marketing authorisations authorised in national proceedings are described below.
Decree No. 2008-433 of 6 May 2008.
Article R.5141-39 of the Public Health Code.
Content of the declaration (in the form of separate documents)
- A letter of request for renewal from the holder ;
- The list of authorised modifications, since obtaining the marketing authorisation or the last renewal, with, for each of them, the subject matter as notified in the Decision ;
- The history of batch reminders ;
- Pharmacovigilance data (see volume 9B).
Recipient of the request
For reasons of ease of management and support, it is requested not to send a paper file in parallel with a filing by email.
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
or by email to: firstname.lastname@example.org (chemical veterinary medicinal products) or email@example.com (immunological veterinary medicinal products)
Contact for information : +33 02 99 94 66 65
Deadline for processing the application
The decision must be notified before the expiry date.