Patients in the EU now safer from counterfeit medicinesFighting counterfeit medicines in the EU with unique safety features
Beginning with 9 February 2019 all prescription based medicinal products will be sent to the European market with unique safety features that will enable verification of authenticity of each separate packaging. This will assure traceability of medicines from manufacturers to end users, improved protection for medicinal product manufacturers and, what is most important, greater safety for patients.
Counterfeit medicinal products pose a serious threat to public health and numbers of counterfeit cases are on the rise. In order to step up the fight against counterfeit medicines in the legal supply chain, EU member states will begin implementing the provisions of Delegated Regulation (2016/161/EU) on 9 February 2019. The Regulation brings traceability of medicinal products from the manufacturer to the end user, greater safety for patients and more effective protection for medicinal product manufacturers.
The Delegated Regulation prescribes mandatory placement of security features on all prescription medicinal products. Each unit of packaging of a prescription medicine will bear a unique identifier in the form of a two-dimensional bar code and in human readable format and an anti-tampering device.
In order to prevent entry of counterfeit medicines into the European market EU member states established National Medicines Verification Systems (NMVS) and the European Medicines Verification Organisation (EMVO) established the central European hub (EMVO), through which medicinal product manufacturer will be able to enter their information on safety features on each packaging that will then be exchanged with national verification systems.
In Slovenia the task of establishing and managing the national verification system has been entrusted to the Medicines Verification Institute - MVI (Slovenian: Zavod za preverjanje avtentičnosti zdravil – ZAPAZ), which was founded on 6 October 2016 by representatives of all stakeholder in the medicinal product supply chain: the Forum of International Research and Development Pharmaceutical Companies, EIG, Association of Slovenian Medicinal Product Manufacturers, EIG, the Slovenian Chamber of Pharmacy and the Slovenian Chamber of Commerce, Section of medicinal product wholesalers.
Over the past two years the MVI successfully established a national information system for verification of medicinal product authenticity - SiMVS, which received a positive audit report from EMVO in April 2018 and became the first to connect to the central European hub: “Since then our services have helped pharmacies and wholesalers to adapt their information systems and connect to the national information system to begin exchanging information on safety features on product packaging as required by the Directive. Over the past year we concluded agreements with over 200 marketing authorisation holders and holders of temporary permits for exceptional import of medicines which bind us to maintain the national information system to provide uninterrupted exchange of information. In the future our primary role will be to serve as a point of contact between manufacturers on one side and pharmacies and wholesalers on the other in order to resolve any alarms raised due to suspected counterfeits in the system. If such suspicions are confirmed, the Public Agency for Medicinal Products and Medical Devices of the Republic of Slovenia will take over as the auditing body. We are expecting slightly more technical issues in the initial period since data is still being uploaded into the system, but we do hope the phase passes without major difficulty,” said MVI Director Mr. Mitja Pirman upon commencement of Directive implementation.
Secretary General of the Forum of International Research and Development Pharmaceutical Companies, EIG, mag. Barbara Stegel expressed her satisfaction with the successful establishment of the new medicinal product verification system since it was in fact the innovative pharmaceutical industry that promoted the establishment of an additional layer of protection: “The Forum as a representative of innovative pharmaceutical industry in Slovenia is a recognised and reliable partner in the efforts towards finding the best solutions in the field of medicines, health and healthcare. We are well aware of the dangers posed by counterfeit medicines, so we strived for the establishment of an additional safety system that would enable traceability and verification of authenticity of each separate medicinal product packaging, prevent unauthorized tampering and provide greater safety to patients. Counterfeit medicinal product are most commonly found through new technologies online, but they can and do find their way into the legal supply chain as well. That is why we gladly took on the task of implementing European legislation that will certainly make us more effective in the fight against medicinal product counterfeiting. The forum is also the initiator and founding member of the Medicines Verification Institute - MVI, with which we and other stakeholders in the Slovenian medicinal product supply chain established an effective system for verifying the authenticity of medicinal products and promoting collaboration that enables effective prevention of the entry of counterfeit medicines into the legal supply chain and pave the way for faster and better coordinated response to suspected cases of counterfeiting. And what is most important - we are certain that the new medicinal product verification system brings greater safety to patients in Slovenia and other EU member states.”