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Control of Medicines: News & General Information

Product Specific Guidelines and Procedures for Human Biologicals OCABR

(13/12/11) The procedures and product specific guidelines for OCABR, updated in December 2011, are available to download with updates including a revised EU administrative procedure for OCABR and revised product specific guidelines for blood and vaccine, in force from 1st January 2012.

Read the OCABR Procedure preface & Note to users

Download the OCABR Guidelines 2011

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.

Events

Symposium on combating counterfeit and other illegal medicines. Download the press release.

 

16th Annual Meeting of the General European OMCL Network (GEON), Düsseldorf, Germany, 23-27 May 2011. Download the press release.

 

Additional Information & Documentation

2011 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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