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Testing of counterfeit / illegal medicines within the GEON

(General European OMCL Network)

Background

For many OMCLs in the GEON, there has been a significant shift over the last few years from planned market surveillance testing (with products selected according to risk-based criteria) to the analysis of counterfeit and illegal medicines on behalf of other authorities such as customs, police, enforcement / food inspectors, courts and forensic laboratories.

This additional task involves a wide variety of analytical techniques for authenticity testing (comparison of a suspected counterfeit sample with the original product) and screening for unknown products (e.g. in a suspicious "white powder" confiscated by the police). Over the last few years, the OMCL Network and the EDQM have responded to the increasing number of potentially counterfeit and illegal medicines through a series of measures outlined below.


In October 2006, the EDQM set up a data repository for Network members involved in the testing of counterfeit and illegal medicines. This information platform is used by the OMCLs on a voluntary basis to make test reports available in a standardised format; it is reserved for Network members and allows rapid exchange of information on testing activities in the area of falsified medicines.


Following an initiative of the Network, since 2007 the EDQM has been organising a programme on the testing of Suspicious Unknown Products (SUP). This programme aims to evaluate whether OMCLs of the Network are able to identify (and where possible quantify) unknown active pharmaceutical ingredients (APIs) in a selected sample.


At its Annual Meeting in Split, Croatia in 2010, the Network decided to publish the first document covering this field of activity on the EDQM's website. This document provides an overview of the contributions of the OMCL Network in supporting the implementation of the MEDICRIME Convention of the Council of Europe and is aimed at raising awareness of the essential value of the work of OMCLs in fighting against counterfeit and other illegal medicines.

 


These concerted efforts of the Network also led to the organisation of the first symposium for OMCLs focusing on all aspects of testing of falsified medicines, which was held on 29-31 March 2011 at the EDQM in Strasbourg.


During the Annual Meeting of GEON 2011 in Düsseldorf, Germany, the Network members agreed to establish a working group dealing with relevant aspects regarding the testing of counterfeit and illegal medicines.


 

Market Surveillance Studies on Suspected Illegal Products (MSSIP) within the Network

Since 2012, the OMCL Network is developing joint market surveillance programmes on suspected counterfeit and illegal products (MSSIP) to cover a large part of the European market in a co-ordinated campaign targeted to defined product groups.

 

Twenty one OMCLs participated in the first study (MSSIP001), focused on Slimming Dietary Supplements. 370 products from the legal and the illegal supply chain were analysed for the presence of undeclared active ingredients. A summary of the study report is now available.

 

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