To protect the EU pharmaceutical market from the entry of falsified medicines, the European Medicines Verification Organisation (EMVO) was created as a joint initiative of EU stakeholders, representing manufacturers, wholesalers and community pharmacists. According to EU Directive 2011/62/EU pharmaceutical manufacturers must ensure all applicable medicines entering the supply chain have a unique identifier and tamper-evident seal. This allows each pack of medicine to be verified, for authenticity, at the point of dispense. The new system will apply to all applicable medicines dispensed throughout EU nations and from February 2019, all countries within the European Union must have a National Medicines Verification System connected to the European Medicines Verification Organisation’s central Hub to verify the authenticity of a medicine and prevent counterfeit drugs from being dispensed.
National Medicines Verification Organisations are taking shape across Central and Eastern Europe as illustrated below.
In Poland, KOWAL, the Polish Medicines Verification Organisation was established in July 2017 with the aim to create and implement an IT system for verifying the authenticity of medicinal products. The obligation to create the organization results from the Community regulations aimed at preventing drug falsification that threatens the health and lives of patients.
The Polish Medicines Verification Organisation was appointed by four organisations:
- Polish Employer Association of Pharmaceutical Industry
- Employers’ Union of Innovative Pharmaceutical Companies INFARMA
- Association of Parallel Importers of Medicinal Products
- Polish Pharmaceutical Chamber
KOWAL is currently focusing its efforts on selecting a software supplier for the medicines authenticity verification system.
In Croatia, HOPAL, the Croatian Medicines Verification Organisation was founded in 2017. This is as a key step in the implementation of the serialization process, the establishment of a national verification system and a national repository. Founders are Pharmaceutical Industry Association, Innovative Pharmaceutical Initiative and Croatian Chamber of Commerce. Croatian Chamber of Pharmacists will participate in the work of HOPAL as an active member.
HOPAL has recently concluded an agreement with Solidsoft Reply in order to implement, develop, test and operate the Croatian Medicines Verification System. The implementation of the National Medicines Verification System in Croatia represents a significant step forward in Croatia ensuring the safety of patients across the country by preventing falsified medicines from being dispensed.
BgMVO, Bulgarian Medicines Verification Organisation was established in 2016 as a non-profit association to support the implementation in Bulgaria of Directive 2011/62/EU for preventing entry of falsified medicinal products into the supply chain. The founders of the BgMVO are five organisations representing the stakeholders involved in the manufacturing and distribution of medicines – Association of the Research-based Pharmaceutical Manufacturers in Bulgaria, Bulgarian Generic Pharmaceutical Association, Bulgarian Association of Medicines Parallel Trade Development, Bulgarian Association of Pharmaceutical Wholesalers and Bulgarian Pharmaceutical Union.
The main purpose of the BgMVO is to ensure that patients are supplied with authentic medicinal products by building, operating and maintaining an effective drug verification system in the Republic of Bulgaria. BgMVO works in close collaboration with healthcare authorities in Bulgaria.
In January 2018, a meeting of the Bulgarian Medicines Verification Organisation, Softgroup and Bulgarian manufacturers of medicinal products was held in Sofia where the requirements for connecting the manufacturers of medicinal products with the European Medicines Verification Hub were discussed.