Procedures for reporting veterinary medicinal product shortages
The issue of medicinal products supply shortages is a major topic for both animal and human health. In veterinary medicine, the holders or their representative (responsible for placing on the market) are obliged to report to Anses any risk of shortage of a veterinary medicinal product which could lead to a risk to human health, animal health or animal welfare.
In order to improve the information of veterinary practitioners, the French agency for veterinary mledicinal products (ANMV), within Anses, has decided since 2019 to publish online on its web portal the various shortages considered critical.
Published data include:
- the name of the medicinal product concerned,
- the estimated date of return of the product to wholesale distributors,
- the reason for the shortage,
- if necessary, a proposal of therapeutic alternatives validated by the ANMV (release of particular batches, preparation of autovaccine, import of batches/medicine authorised in another country...).
After more than 4 years of using the previous model of shortage declaration and an exchange with the French industry union (SIMV), a new sheet is proposed whose objective is to simplify the reporting procedures.
Potential shortages that may be critical must be reported to ANMV by MA holders as early as possible prior to their occurrence, in order to study potential alternatives.
Warning : in order to be able to ensure up-to-date information, it is essential that the holders or their representatives update as necessary the information provided in the declaration, in particular if planned replenishments are postponed, and also systematically confirm returns to the market as soon as they become effective.
At the same time, the regulatory references mentioned in the Charter on good practice for the management of supply shortages of veterinary medicinal products have also been updated.
More information about shortages