Marketing cessation / withdrawal of marketing authorisation
Paragraph 13 of Article 58 of European Regulation 2019/06 states that the marketing authorisation holder must inform the competent authorities, in advance, of any cessation of marketing of a veterinary medicinal product, of the reasons justifying it and of any action he intends to take.
Plans to suspend or abandon marketing authorisations are to be notified to the ANMV as far in advance as possible, if possible 12 to 24 months before the end of marketing of the last batches. This declaration is made using the declaration template available on the ANSES website. The corresponding e-mail is to be sent to DQ_ANMV@anses.fr.
After examination of the data provided, the impact of the discontinuation on the national market is assessed. In the case of a high impact, the search for transitional and alternative measures is continued.
At the same time, plans to abandon marketing authorisations are forwarded to the SIMV (Union of manufacturers), with the consent of the holder (or his representative).
Manufacturers interested in taking over MAs should contact SIMV directly (contact@simv.org)
‘Good practices for the management of these declarations’ specify the actions to be taken by each of the parties involved and the arrangements for exchanges.
Attention: Advance declarations do not replace the official information to the ANMV (enreg@anses.fr) on the abandonment of MAs, which will have to be carried out in the month preceding the exact date of abandonment.