The Council of Europe and its EDQM have adopted a multi-level, anti-counterfeiting strategy comprising various aspects such as legislative actions against pharmaceutical crime by means of the Medicrime Convention, awareness campaigns against illegal internet pharmacies, multi-sectorial training for officials from member states and increased inspection and testing activities, e.g. through the network of Official Medicines Control Laboratories.
The aim of eTACT is to ensure the traceability of individual packs of medicines using mass serialisation.
It is based on the principle of generating a Unique Medicine Identifier (UMI) at the manufacturing stage. This UMI can be traced and verified by the different stakeholders in the legal supply chain. Verification must be performed at the dispensing stage. Patients are also allowed to verify the authenticity of their medication: it is a unique feature of the EDQM project that will significantly contribute to strengthening the public’s confidence in the legal supply chain.
As a public, intergovernmental organisation, the EDQM promotes a public governance for the eTACT system to ensure the confidentiality of the data handled by the system.
The project is currently restricted to the traceability of secondary packaging. It is designed for any medicinal product and is opened to any registered business stakeholders willing to join the project. All 37 member states of the European Pharmacopoeia are eligible to use eTACT.
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Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products