Procedures for declaring discontinuations or abandonments of marketing authorisations for veterinary medicinal products in France
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.
At the same time, at the request of the French Government and in close collaboration with all French stakeholders, the WHO (World Health Organisation) conducted a project funded by the European Commission (SRSP: Structural Reform Support Programme). The latter aimed to identify the causes of shortages and lack of availability of off-patent antibiotics in France in both human and veterinary medicine and to propose effective solutions at national and European level to address them while preserving the environment (One Health approach)[1].
This project has led to the following two priority actions in veterinary medicine:
- Establish a procedure for manufacturers to inform of the withdrawal of an antibiotic from the market or their intention to do so: pilot : ANMV (French agency for veterinary medicinal products) – partner SIMV (French Veterinary Medicines and Diagnostis Industry Union),
- Prevent withdrawals of antibiotics from the market by establishing partnerships and facilitating the transfer of MAs (marketing authorisations): pilot SIMV – partner ANMV.
While these actions initially concerned only antibiotics, ANMV and SIMV agreed to apply it to all veterinary medicinal products.
This is why the ANMV has defined with the SIMV a coordinated approach through Good Practices on the early management of a marketing authorisation suspension and/or abandonment for a veterinary medicinal product.
As part of these good practices, the person responsible for placing a veterinary medicinal product on the market or the marketing authorisation holder uses the declaration form for ‘planned suspension of marketing and/or abandonment of marketing authorisation for a veterinary medicinal product’, which he or she will have taken care to complete precisely before sending it to the Agency.
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, with the consent of the holder (or his representative).
Manufacturers interested in taking over MAs should contact SIMV directly (contact@simv.org).