Principles for Mutual Recognition of Control Results

At its October 2009 meeting in Uppsala, the Heads of Medicines Agency (HMA) support a risk-based approach for selection of MRP/DCP products for testing and endorsed the document on the ‘Mutual Recognition of Control Results'. The document is now presented to the OMCL's representatives for implementation of its principles.

Communication letter

HMA Working Group on Product Testing Document - Principles for Mutual Recognition of Control Results

GEON Annual Meeting 2010

The EDQM held its 15th Annual Meeting of the General European OMCL Network in Split from 17 to 21 May 2010. This conference was organised with the help and support of the Croatian Agency for Medicinal Products and Medical Devices (HALMED). For more information, download the press release.

Product Specific Guidelines and Procedures for Human Biologicals OCABR

The procedures and product specific guidelines for OCABR, updated in December 2009, are now available to download. For more information, click HERE.

General European OMCL Network Publish New Policy Documents

During its last Annual Meeting, which took place from 25-29 May 2009 at the premises of the "Austrian Food and Drug Agency" (AGES) in Vienna, the General European OMCL Network (GEON) adopted a number of new, and revised versions of existing, documents. Amongst others, the Terms of Reference (TOR) and its annexes were revised. For further information click HERE.

Quality Management Guidelines on Validation of Computerised Systems

(07/07/09) New General European OMCL Network guidelines are available to download via the Quality Management (QM) Guidelines section.

Proficiency Testing Scheme (PTS) Study for Radiopharmaceuticals

In 2010, the EDQM will propose a PTS study on radiopharmaceuticals, which will consist of a determination of radiochemical purity by planar chromatography according to a given protocol. For more information on the proficiency testing scheme in general, click HERE.

Events

15th Annual Meeting of the General European OMCL Network (GEON), Split, Croatia, 17-21 May 2010

Download the press release.

Additional Information & Documentation

2010 Proficiency Testing Scheme (PTS) Studies - Download the planning.

"The EU/EAA Network for Official Control Authority Batch Release of Biologicals for Human Use", The Regulatory Affairs Journal, June 2002

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