A new specific guideline for influenza vaccine and ten revised guidelines for various vaccines were adopted in the field of Official Control Authorities Batch Release (OCABR) during the eleventh annual meeting of European Network of Official Medicines Control Laboratories (OMCLs), organized by European Directorate for the Quality of Medicines (EDQM) in Limassol, Republic of Cyprus.
These guidelines will be published by the end of 2006 and implementation is expected by January 1, 2007. Additionally two new and two revised product specific guidelines for vaccines have been approved for external consultation within the months to come.
A session concerning MRP-product testing group was also held as part of this meeting. The final report of the 2005 testing programme was also presented. In total, 14 OMCLs actively participated in the programme. The testing group adopted a general document describing the principle of the co-operation in post-marketing surveillance of MRP-products. A status report of the MRP-product testing database project, which will be finalised in 2007 was provided. The testing of traditional Chinese medicines was also discussed in a workshop of specialists to examine the possible contribution of the OMCLs in this field, EDQM informed Pharmabiz.
The OMCL Network was formed in 1994 under the aegis of the Council of Europe in Strasbourg, France, to co-ordinate the administrative and technical activities of the OMCL's, to facilitate the exchange of knowledge amongst authorities in Europe and to influence future development through harmonised common standards, based on the legal requirement for testing medicinal products.
With the initiation of EDQM of the Council of Europe, about 180 representatives from 32 countries attended the Annual meeting of the European Network of the OMCLs during second week of May, 2006. It was organised to review the activities of the Network in 2005 and to discuss the work programme for the year to come.
The meeting aimed at bringing together the OMCLs of the General European Network in different areas of interest (physico-chemical, pharmaceutical, biological) to discuss and exchange viewpoints of common interest in the field of controlling and testing medicines by independent Official Medicines Control Laboratories (OMCL).
Representatives from Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Serbia-Montenegro, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom took part in the meeting.