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11/02/2022

Official release of a batch of inactivated or live rabies vaccines for veterinary use - Official Batch Protocol Review

In accordance with the provisions of Article 128 (paragraphs 3 to 9) of Regulation (EU) 2019/6, Anses-ANMV is officially releasing batches of immunological products (OCABR) for rabies vaccines. Consignments of inactivated rabies vaccines for veterinary use placed on the market in France shall be officially released by the ANMV, which is the competent national authority. This official batch release includes a documentary analysis of the batch manufacturing and analytical checks carried out at the Laboratory of the Anses de Nancy. 

The ANMV also issues OBPR (Official Batch Protocol Review) certificates on the basis of Article 128(1) of Regulation (EU) 2019/6. This official release of consignments of vaccines for veterinary use consists of a documentary review of the batch manufacturing showing that the control tests have been carried out in accordance with the methods described in the MA dossier. 
 
These certificates may be the subject of mutual recognition between Member States.

OCABR : official release of a batch of inactivated rabies vaccines for veterinary use

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

OBPR : Official Batch Protocol Review

The official release (OBPR) of immunological batches is based solely on a review of the batch release protocol submitted by the applicant. A certificate, according to the European model, shall be published per lot placed on the European market. 

Each of the Member States shall define the list of immunological veterinary medicinal products to obtain an OBPR certificate for marketing in its territory. 

France does not require any OBPR certificates for all immunological veterinary medicinal products. However, France may issue OBPR certificates for other Member States if the immunological veterinary medicinal products concerned have a marketing authorisation in France. 
 
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