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Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) for Immunological Veterinary Medicinal Products (IVMPs)
These activities involve the EC/EEA OMCL Network and Mutual Recognition Agreement (MRA) partners countries only.
Background: Veterinary Batch Release Network (VBRN)
This network is an important forum for the confidential exchange of quality and technical information on immunological veterinary medicinal products (IVMPs) and related methods and is a key link in the regulatory chain. As mandated by the European Commission, the EDQM acts as its secretariat. VBRN is a specific network within the General OMCL Network, thus subject to its operating rules. It is supervised by an elected advisory group consisting of 4 representatives from different Member States. A plenary meeting is held annually bringing together all the representatives (their details are available in a contact list) to review the year's activities and to discuss issues concerning the network. This meeting also serves as an opportunity to reconsider the needs for testing different product types and to officially adopt the VBRN procedures and guidelines, which must be approved by all the network's members.
Legal Framework:
Official Control Authority Batch Release (OCABR)
Article 82 of Directive 2001/82/EC, as amended by Directive 2004/28/EC, of the European Parliament and the Council came into force throughout the EC as of 31 October 2005. This article allows, for reasons of human or animal health, a Member State to 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 placed on the market and establishes the conditions under which a restricted test list can be applied. This is referred to as 'Official Control Authority Batch Release'. OCABR performed by any given Member State must be mutually recognised by all other member states requiring OCABR for that product.
Official Batch Protocol Review (OBPR)
Article 81 of Directive 2001/82/EC allows a Member State, where appropriate, to ask a Marketing Authorisation Holder (MAH) to provide documentation to a control authority or an OMCL proving that control tests were carried out in accordance with the methods laid down in the marketing authorisation (MA). This is referred to as an 'Official Batch Protocol Review'. A goodwill agreement has been adopted by the VBRN to mutually recognise OBPR certificates between Member States provided the procedure and rules codified by the network are followed.
This legislation concerns EU/EEA Member States and is also applied by any state having signed a formal agreement, which includes recognition of OCABR, with the EU. Currently, Switzerland has done so via a Mutual Recognition Agreement (MRA).
The Procedures:
Official Control Authority Batch Release (OCABR)
The core administrative procedure for OCABR of IVMPs is the "Procedure for application of article 82 for official control authority batch release if immunological veterinary medicinal products in the European Community", which supersedes the previous guideline III/5372/93. This is used by OMCLs when implementing OCABR at the national level. It is also intended for use by MAHs. It provides guidance on documents used for communication between MAHs and OMCLs and describes the steps involved in the OCABR process, which are summarised below:
The Member State informs the MAH that its authorised IVMP is subject to OCABR. Samples of the batch to be released are sent, along with control reports, to an OMCL within the EU/EEA. If the results are satisfactory, the CA issues an 'Official Control Authority Batch Release Certificate' to the MAH. This certificate means that the batch has been examined and tested by an OMCL in accordance with the OCABR guidelines pertaining to the medicinal product and is in compliance with the approved specifications laid down in the relevant monographs of the European Pharmacopoeia and in the relevant marketing authorisation (MA). The MAH must provide a copy of the OCABR certificate to any other Member State where the batch will be marketed and where OCABR is required for the product. The certificate is recognised by all members of the network.
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 VBRN are informed.
A short list of IVMPs for which Article 82 may be applied using a restricted test list has been agreed upon. This short list is reviewed on a regular basis to ensure it continues to address appropriately product quality and safety needs.
The current list can be found in annex I of the "Procedure for application of article 82 for official control authority batch release if immunological veterinary medicinal products in the European Community".
Official Batch Protocol Review (OBPR)
A similar procedure, "Procedure for A Harmonised Application of Article 81" is applied for OBPR with the difference being that only the completed batch protocols are sent to the competent authority for evaluation. If the results are satisfactory an ‘Official Batch Protocol Review Certificate' is provided to the MAH. The OBPR certificate is recognised by other Member States requiring the Article 81 procedure. If an OCABR certificate is provided instead it must also be recognised.
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 VBRN are informed.
Product Specific Guidelines & Model Protocol Templates
In addition to the procedures, a series of product specific guidelines have been developed by the VBRN, in close collaboration with the Commission of the EU, the Veterinary Pharmaceutical Committee and industry. These documents facilitate the implementation of the relevant articles of Directive 2001/82/EC, as amended by Directive 2004/28/EC, and promote mutual recognition by enhancing transparency and mutual confidence. They were endorsed at the 18th meeting of the Veterinary Pharmaceutical Committee and adopted by the network. Five model templates for the submission of protocols by the MAH for OCABR/OBPR and fifteen product specific guidelines for OCABR are currently in force.
The procedures and guidelines for running OCABR/OBPR apply equally in all Member States. Please see the right-hand menu for further information.
Guidelines & Procedures
To download the product specific guidelines and model protocol templates, please go to the Product Specific Guidelines/Model Protocol Templates (OCABR/OBPR) section.
Procedure for a Harmonised Application of Article 81 for Official Batch Protocol Review of IVMPs in the European Community (updated 22/06/07)
Additional Information & Documentation
Annex IV to the Procedure for the Application of Article 82 and Article 81: VBPR Contact List (updated 05/07/10)
Decision Flowchart for Control Authorities for the Control of IVMPs
Related Links
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 (Reference Documents, Pharmaceuticals Archives 2007 (27/03/07).
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