The European Union, cognisant of the problem of forged medicines in the market, has imposed – effective 9 February 2019 – new duties on all participants in the medicinal products market. Due implementation of these rules may well have key significance to the safety of patients.

9 February 2019 witnessed the coming into force of Directive 2011/62/EU and Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. Between them, these two pieces of EU legislation provide the foundations of the system for verifying authenticity of drugs. In its theoretical aspect, this system is quite simple. The packaging of medicinal products covered by the system has special safety features which prevent tampering and a unique, two-dimensional code which enables verification of the product in a special IT base. When selling such a product, the pharmacist checks the safety elements of the package and scans the code to ensure that it has been input in the data base; in the event that such verification measures give rise to doubts as to the product’s authenticity, it will be quarantined. In order to learn the details of this system’s operation, step-by-step retracing of its operation should be in order.

The database system

In order to implement the new regulations,  a Europe-wide system of databases has been established for storing the product identifiers. This system is administered by dedicated organisations – the European Medicines Verification Organisation (EMVO) managing the central system (the EU hub) and organisations at national level.

Full text (in Polish) is available in Puls Farmacji.