Human Biologicals (OCABR)

The OCABR Network - Human Biologicals

Background & legal framework

As part of the regulation of biological medicinal products, according to Article 114 of codified Council Directive 2001/83/EC relating to medicinal products for human use and the amending Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, a Member State laboratory may, but is not required to, test a batch of an immunological medicinal product or a medicinal product derived from human blood or plasma before it is marketed. 

All twenty-seven EU Member States, EEA partners and MRA partners for OCABR (e.g. Switzerland) may decide to apply OCABR. All the procedures and guidelines for the running of OCABR apply equally to all Member States and as such, where applied, OCABR is mutually recognised throughout the EC. The Directives require Member States to recognise OCABR carried out in any other Member State and the marketing authorisation holder (MAH) must provide a copy of the OCABR Certificate to the Competent Authority (CA) of the Member State where the batch will be marketed.

The procedure

The Member State contacts the marketing authorisation holder (MAH) to indicate a need for OCABR certificates for batches of a product on their market. Samples of the batch to be released are sent, along with production and control protocols, 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 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 specification laid down in the relevant monographs of the European Pharmacopoeia and in the relevant marketing authorisation (MA).

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 network are informed.

The OCABR network today

Today, the OCABR network for batch release involves 31 Member States/Countries. It is an important forum for confidential exchange of quality and technical information on products and methods and a key link in the regulatory chain for biological medicinal products. The EDQM acts as the Secretariat for OCABR network activities, as mandated by the European Commission, and maintains a contact list of OMCLs in the EC carrying out OCABR. The network is supervised by an elected advisory group consisting of six representatives from different Member States (three for blood and three for vaccines). A plenary meeting is held annually bringing together all the representatives to review the years activities and to discuss issues concerning the network. It serves also as an opportunity to officially adopt the OCABR procedures and guidelines which must be approved by all the OCABR network members.

Product Specific Guidelines & Procedures for OCABR

The core administrative procedure for the OCABR is the EC Administrative Procedure for Official Control Authority Batch Release. This procedure is used by OMCLs in Member States when implementing OCABR at a national level, to facilitate them meeting the requirements of Directive 2001/83/EC, as amended by Directive 2004/27/EC. It is also for use by MAHs and provides guidance on communication between MAHs and OMCLs involved in batch release. The procedure describes the steps involved in the OCABR process. In addition to the administrative procedure, there is a series of product specific guidelines.

The procedures and guidelines are all elaborated by a panel of experts from various OMCLs, under the aegis of the EDQM, to ensure a common approach to testing in the OMCLs across the EU/EEA and transparency for all users of the system. The guidelines are adopted only after consultation within the network and public enquiry involving interested parties. Fifty seven new and revised product guidelines are in force as of January 2008.