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02/03/2022

Fee for Official batch release — OCABR procedure and OBPR procedure

Batches of inactivated or live rabies vaccines for veterinary use placed on the market in France shall be subject to an official batch release (OCABR) 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 Anses Laboratory located in Nancy.

A fee for each application for the official release of batches of rabies vaccines is due according to the type of control carried out (tariffs T 00010 to T 00014 of the service catalogue).

(OCABR: Official Control Authority Batch Release)
 
The ANMV also issues OBPR certificates on the basis of Article 81 of Directive 2001/82/EC. This official release of batches 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.

A fee for each application for the official release of a batch of vaccine is due (T 00263 of the service catalogue).

(OBPR: Official Batch Protocol Review)

Prices:  prestations Anses (PDF)