Starting from 9 February 2019, each package of any Belupo prescription medicine has been provided with a unique code and security features. This is the case with all prescription medicines in Europe.
The likelihood that a falsified medicine will appear has thus been reduced in over a thousand Croatian pharmacies, each package is now traceable, and the safety of administration has been increased.
After comprehensively preparing the project, Belupo's team successfully implemented a prescription medicines authentication system within the defined timeline. The serialization of prescription medicines aims to prevent the dispensing of falsified medicines in the legitimate supply chain.
This is presently one of the largest and most demanding IT projects. It establishes a complex pan-European network for exchanging a variety of information. Its implementation includes defining and testing the solution, regulatory activities, qualification activities, changes in the operating system, adjustment of packaging, placement of security notices, software solutions to manage serialization data, and adjustment of relations with partners and NMVOs responsible for implementing national serialization repository systems.
According to the information available, the appearance of falsified medicines in authorized supply chains has never been recorded in Croatia. Also, Belupo is not aware of any attempts to falsify Belupo products on any other markets. Medicine falsification is a big issue across the world, moreover, a problem that has been growing significantly.
Serialization required introducing technologies and controls for all factors affecting their implementation (packaging, ink, print quality, compatibility of anti-tamper protection and commercial boxes…).
This is why all Belupo’s divisions have been affected by the implementation and needed to adjust their procedures. By placing our first serialized batches on the market, Belupo has taken a big step forward and we have thus completed a demanding period of preparation for compliance with the relevant regulatory requirements. Ahead of us are further process adjustments to the complex serialization requirements.
The serialization project allows more stringent supervision of medicines marketed in Europe, whereas Croatia, being a European Union Member State, is required to implement the provisions of the Falsified Medicines Directive and the associated Commission Delegated Regulation. According to this legislation, all EU Member States were required to establish national medicine verification systems through their national organizations by 9 February 2019, as of which date the serialization requirements became effective. Croatia did this in time. Almost 1,200 end users, including manufacturers, all pharmacies, hospitals and medicine wholesalers, are connected to the system. HOPAL is available to all stakeholders in the medicine distribution chain in Croatia for technical support, which includes maintenance of the Verification System.