The official release of immunological batches shall be based on a review of the batch release protocol submitted by the applicant and supplemented by the analytical results carried out by Anses-Nancy (OCABR). A certificate, according to the European model, shall be published per lot placed on the European market.
A list available in Annex I to the EDQM procedure defines all veterinary medicinal products which may be the subject of an OCABR certificate application according to Member States (MS). The procedure is accessible at this link. In France, only for rabies veterinary medicinal products, an OCABR certificate is required before they are placed on the market.
Mutual recognition :
Each holder of the European Union (EU) chooses the country in which he wishes to obtain the OCABR certificate. If the certificate has been issued by a Member State other than the country of marketing then the holder must make mutual recognition by the Member State concerned before marketing.
In the case of France, prior to the placing on the French market of rabies veterinary medicinal products, the holder must proceed to mutual recognition by France if the certificate comes from another country of the European Union.
For more information on the European network for the release of immunological products and its activities, the link can be found here : : https://www.edqm.eu/fr/veterinary-biologicals-ocabr/obpr-
EU administrative procedure for the application of the official release of consignments of immunological veterinary medicinal products by the control authorities in accordance with Article 128