French Public Health Code
In forceWithout prejudice to the conditions laid down when the marketing authorisation is granted pursuant to the provisions of the fourth paragraph of Article L. 5141-5, the company operating the veterinary medicinal product shall forward to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, in the form of a periodic safety update report, information relating to the adverse reactions which it has reported or which have been reported to it, together with a scientific evaluation of the benefits and risks of the veterinary medicinal product:
1° Immediately on request ;
2° Half-yearly:
a) During the period between the issue of the marketing authorisation and the actual marketing of the veterinary medicinal product in at least one Member State of the European Union ;
b) During the first two years following the first placing of the medicinal product on the market in at least one Member State of the European Union;
3° Annually for the following two years;
4° Every three years thereafter.
After the marketing authorisation has been granted, the company responsible for the operation of the veterinary medicinal product may request a change to the above periodicity in accordance with the procedure applicable to the change to the authorisation in question.
