Work plan of the Counterfeit/Illegal Medicines Working Group


The first meeting of the Counterfeit/Illegal Medicines Working Group of the OMCL Network took place on 02 November 2011 and preceded the Centrally Authorised Product (CAP) Annual Meeting of the EEA OMCL Network at the premises of INFARMED in Lisbon, Portugal. In total, 14 representatives from 13 member states accepted the invitation to present their ideas about strengthening the collaboration between OMCLs in the field of testing of falsified medicines and similar products and to establish a work programme for the Group.

 

It was decided that the scope of the Group should not be limited to medicines for human use with potential risks for falsification, but should also extend to veterinary medicines and designer drugs.

The following topics, for which a co-ordinated approach should be fostered, were identified at the meeting:

  1. Internal information exchange between the OMCLs using existing IT platforms (e.g. the OMCL inventory database) and other forms of communication such as Annual Reports. The exchange of data should not be restricted only to information about testing activities in connection with the laboratory control of suspicious products confiscated by customs and/or police on request by the prosecution/court, but should also include scientific discussions highlighting new trends in the field of falsified medicines.

  2. Identification of training needs on technical subjects relevant for the testing of falsified medicines and the development of appropriate training programmes. In this respect, the principle of peer assistance (training of OMCL technical personnel by partner OMCLs experienced in conducting certain techniques) would apply.

  3. Development of joint market surveillance programmes on counterfeit and illegal products to cover a large part of the European market in a co-ordinated campaign targeted to defined product groups.

  4. Assistance in the establishment of an effective, user-friendly database hosting records on testing activities of falsified medicines and similar products in the Network. In the long-term, this database should allow communication with other stakeholders such as police, customs officers and regulators using existing, complementary information systems.


The group will continue to meet on a regular basis to follow-up the decisions taken at the first meeting.

© European Directorate for the Quality of Medicines & HealthCare