“Falsified medicines (the term ‘falsified’ is used to distinguish the issue from IP violations, so-called ‘counterfeits’) are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level.
Part of the requirements laid down in the directive is the harmonisation of safety features for medicinal products within the European Union. These safety features “should allow the verification of the authenticity and the identification of each individual pack”. For that purpose, each pack will have to be marked with a unique identifier. Furthermore, the directive requires the establishment and management of a repositories system that will store the unique identifiers and contain information on the safety features. By means of a Delegated Regulation, the European Commission will set out “the characteristics and technical specifications of the unique identifier of the safety features” as well as “provisions on the establishment, management and accessibility of the repositories system”.
The aim of establishing the Slovak Medicines Verification Organization is to develop
and implement an effective system for verifying the authenticity of medicines in the Slovak Republic, which will not be operated for the purpose of achieving or
generating a commercial profit, while the costs of operating this system will be borne by the holders of authorization for the production of medicines provided
protective elements.
The aim of establishing the Slovak Medicines Verification Organization is also to create a comprehensive framework for the implementation of Directive 2011/62/EU, which will determine, among other things, access to data, control conditions and operational rules of the National Register, which will be connected to the Central and other National Registers in within the EU member states, which will create a Registration System, whereby within this platform they will
the participants of the pharmaceutical chain can verify the authenticity of each drug, while the Registration System will be interoperable between individual Member States and will work in relation to all drugs with the obligation to be equipped with protective elements.
