Quality & use of medicines
Anti-falsification activities
Falsified medical products (medicines and medical devices) pose significant risks, potentially undermining the effectiveness of treatments and even endangering patients’ lives. To combat these risks and protect public health, the EDQM leads comprehensive efforts to foster international dialogue and co-operation, encourage expertise and information sharing, and develop tools, frameworks and strategies for risk prevention and harm mitigation. These activities are conducted mainly through the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH), its subordinate Committee of Experts on Minimising the Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED), and the OMCL Falsified Medicines Working Group. The EDQM also provides support to the Council of Europe MEDICRIME Convention and its Committee of the Parties (CoP).
Work programme
The adoption of Recommendation CM/Rec(2024)3 on reporting of disappearances of medicinal products for human and veterinary use from the legal supply chain by the Council of Europe Committee of Ministers was one of the highlights of the CD-P-PH/CMED’s work programme in 2024. This recommendation raises awareness on the importance of informing health regulatory authorities of disappearances of medicines. In parallel, good progress was made in drafting accompanying guidance helping authorities with the implementation of this recommendation.
In June 2024, the 7th CMED workshop for GMP/GDP/Pharmacy inspectors took place in Sofia, Bulgaria, with participants from Bulgaria, Georgia, Republic of Moldova and Romania. They sought to raise awareness of signals that could indicate cases of falsification, taking an interactive and hands-on approach based on real-case scenarios.
Major progress was made throughout 2024 in developing guidance on definitions related to the fight against falsified medicines.
Borderline products (namely, cases in which it is not clear from the outset whether a given product is a medicine or another health product) represent a specific challenge. The Network on Borderline Products provided support to its members on issues touching on the enforcement or supervision of legislation for borderline products. Several cases were discussed by the network under the governance of the CD-P-PH, which is responsible for the network. A plenary meeting was organised in co-operation with the Bulgarian Drug Agency in June 2024 and an online meeting was held in November.
Communication with partners and stakeholders
In the spring of 2024, representatives of the EDQM took part in the meeting of the EU Heads of Medicines Agencies’ Working Group of Enforcement Officers (HMA-WGEO) to strengthen their co-operation. The EDQM had the honour of hosting the autumn plenary meeting of this network in Strasbourg with 81 participants from 25 European member states and beyond.
The EDQM CD-P-PH/CMED secretariat and chair attended the plenary meeting of the MEDICRIME CoP and actively worked with its secretariat on aligning activities in this and in other fields where the CD-P-PH/CMED had projects underway.
Publications, databases and website
The EDQM’s Know-X database stores comprehensive information on individual cases of falsified medical products (medicines and medical devices). The database enables health and law-enforcement authorities across Europe to share information and to act more rapidly in cases of suspect medical products (for instance via its “Rapid Alert” function that allows users to alert others to new cases in real time). The CD-P-PH/CMED and the OMCL Falsified Medicines Working Group work together to maintain the database and continue to work on improvements. They also co-operate on promoting the database and offer training to users.
More information is available on the EDQM’s dedicated Anti-falsification activities web page.
