Veterinary Biologicals (OCABR/OBPR)

These activities involve only the OMCL Network - EC/EEA and MRA partners

Background & legal framework

The Directive 2001/82/EC, as amended by Directive 2004/28/EC, came into force throughout the EC as of 31 October 2005. Article 82 of the Directive allows, for reasons of human or animal health, that a Member State may request samples of each batch of a given immunological veterinary product (IVMP) to be submitted to a Competent Authority (CA) for official testing by an OMCL before it is marketed. This is referred to as 'Official Control Authority Batch Release'. Article 82 also stipulates however that the results of OCABR performed by any given Member State must be mutually recognised by all other member states requiring OCABR for that product.

A short list of IVMPs for which Article 82 may be applied has been agreed upon by the Member States. This list is reviewed on a regular basis to ensure it continues to address appropriately the needs of product quality and safety based to address reduced testing schedules based on risk assessment. The procedure for application of Article 82 supersedes the previous guideline III/5372/93.

Article 81 of the Directive allows a Member State, where appropriate, to ask a MAH to submit written proof to a CA or an OMCL that control tests were carried out in accordance with the methods laid down in the marketing authorisation (MA). This is referred to an 'Official Batch Protocol Review'. A goodwill agreement has been adopted by the network members to mutually recognise OBPR certificates between Member States provided the procedure and rules codified by the network are followed.

All twenty-seven EU Member States, EEA partners and MRA partners for OCABR (e.g. Switzerland) may participate. A contact list of OMCL/CAs for OCABR/OBPR is available. The procedures and guidelines for the running of OCABR apply equally to all.

The OCABR procedure

The Member State contacts and informs the marketing authorisation holder (MAH) that its particular authorised IVMP is subject to OCABR before being placed on their market. Samples are sent, along with control reports, to an OMCL within the EC. If the results are satisfactory, the CA issues an 'Official Control Authority Batch Release Certificate' to the MAH. This OCABR certificate means that the batch of IVMP has been examined and tested by an OMCL within the EC in accordance with the OCABR product specific technical guidelines. If the results are unsatisfactory, the batch is given a certificate of non-compliance and may not be placed on the market. All members of the OCABR/OBPR network are informed.

A similar procedure is applied for OBPR with the difference that only the completed batch protocols are sent to the competent authority for evaluation. If the results are satisfactory an OBPR certificate is provided to the MAH. If the results are unsatisfactory, the batch is given a certificate of non-compliance and may not be placed on the market. All members of the OCABR/OBPR network are informed.

Member States not requesting the Article 82 procedure for a short-listed IVMP but who require the Article 81 procedure for the given product should also accept an OCABR certificate if OCABR has already been performed for that batch in another Member State. If a Member State applies OCABR for a given short-listed product, only an OCABR certificate is acceptable.

Product Specific Technical Guidelines & Model Protocol Templates

A series of procedures and guidelines have been developed by the CA/OMCL network for IVMPs, in close collaboration with the EC Commission, the Veterinary Pharmaceutical Committee and industry, to facilitate the implementation of the relevant articles of the Directive and to promote the mutual recognition required by enhancing transparency and mutual confidence. The procedures and guidelines were endorsed at the 18th meeting of the Veterinary Pharmaceutical Committee and adopted by the OCABR / OBPR network. The procedures for Article 81 and Article 82 respectively, five model templates for submission of protocols by the MAH for OCABR / OBPR and fifteen product specific technical guidelines for OCABR are available as of August 2007.

Product Specific Technical Guidelines & Model Protocol Templates

To download all the product specific technical guidelines and the model protocol templates for submission by a MA for OCABR / OBPR, please go to our 'Batch Release Guidelines' webpage.

Additional Information and Downloads

Procedure-Article 81

Procedure for Application for Article 81 (updated 22/06/07)

IVMP_Flowchart

Decision Flowchart for CA for the Control of IVMPs

A document 'Recommendations on the Implementation of Article 82 of Directive 2001/82/EC, as amended by Directive 2004/28/EC for Official Control Authority Batch Release' and a series of annexes related to implementation of Article 82 are also available on the EC Commission website.

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