News & Events
Serialization of medicines – starting from today authentication of medicinal products further guarantees patient safety
February 9th 2019
Croatia has duly established an end-to-end medicines verification system which provides an assurance of safe medicine supply to the patient
The Croatian Medicines Verification Organization (HOPAL) has within proscribed timeframe successfully completed the process of implementation of the National Medicines Verification System for prescription medicines, which will prevent the supply of falsified medicine through the legal supply chain. Even though Croatia thus far did not have cases of falsified medicine, the aim is to prevent such occurrence and to avoid, in any way, potential endangering of the patients’ health.
‘In partnership with all the stakeholders, we managed to meet the high requirements of a complex IT system and build a platform in a timely manner, providing connection to the European Medicines Verification System (EMVS). All the information regarding products and medicine packages collected in the EMVS, is also available in the National Medicines Verification System, which is fully functional and ready to start today. These procedures increase the safety of the patients, and consequently the protection of patients’ health. Each prescription medicine pack released to the market after February 9th, 2019, must have an anti-tempering device as a protection from opening and a unique identifier, or the serialization number, which can be checked in the system at any time, therefore confirming pack’s origin.’ said HOPAL Executive Director Morana Dostal, adding that this further guarantees that the patient was supplied with a safe and authentic medicine.
According to World Health Organization data, the amount of falsified medicine in the world market is steadily increasing, and almost every other drug purchased online is counterfeit. In developing countries, black market supplies up to 30 percent of all sold medicines, while in developed countries this percentage is smaller, but steadily rising. Free movement of goods and services in the EU can increase the risk of falsified medicines entering the legal market. The serialization project, which imposes additional security features on each medicine pack, thus protecting it from unauthorized opening, aims to keep this prerogative of the united Europe, while at the same time increases the focus on the patient protection and safety.
The serialization project enables tighter control of medicine trade on the European market, and Croatia, as a member of the European Union, is obliged to apply the provisions of the Falsified Medicine Directive and the EU Commission Delegated Regulation on its territory. Accordingly, all EU member states were required to establish national medicines verification systems, through respective national organizations, by February 9th, 2019, the date when the serialization project is being implemented. Croatia has achieved this goal in a timely manner. Starting today, all pharmacies, hospitals and wholesalers should be connected to the system, amounting to nearly 1,200 end users. From the official implementation of the project, HOPAL continues to be available for technical support to all stakeholders in the distribution supply chain of medicines in Croatia, which also implies the maintenance of the Verification System.
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