Drug Serialization Obligation: Where Are PUIs?
In 2019, the European Union implemented a regulation that requires pharmacists to verify security devices and deactivate the unique identifier of medicine boxes. Establishing this serialization obligation is crucial, as it aims to fight falsification. It thus guarantees patients the authenticity and quality of medicines subject to medical prescription.
Where Are PUIs in Drug Serialization?
Since the drug serialization obligation in 2019, France has been delayed in its implementation. If it does not quickly comply with the regulation, it risks sanctions from the European Union.
An instruction published in the Official Bulletin on April 17, 2023 reminds this obligation to healthcare establishments that have a hospital pharmacy (PUI). Indeed, three information notes have already been sent to them in 2018 and 2019.
To date, only 74% of PUIs are connected to the national directory (NMVS). The Ministry of Health has set goals for healthcare establishments to avoid European Union sanctions. The action plan is as follows:
- 80% of PUIs must be connected to the national directory in June 2023;
- 90% in September 2023;
- 100% in December 2023.
This action plan will therefore be quickly implemented within PUIs this year. The Ministry of Health reminds hospital pharmacists of the importance of protecting patients against medicine falsification.
What Are the Risks for Pharmacists and Healthcare Establishments?
If France does not implement 100% drug serialization, the European Commission could initiate proceedings before the European Court of Justice. Heavy sanctions would then be to be feared. Regional Health Agencies (ARS) are responsible for monitoring progress of the system. To avoid penalties, hospital pharmacies must imperatively be connected to the NMVS directory before the end of the year.
Furthermore, community pharmacies are already sanctioned if they do not deactivate the unique identifier on medicine boxes. Indeed, the law of March 9, 2023 allows the director of the local health insurance organization to impose a €2,000 fine in case of non-compliance. This penalty can be repeated every quarter. In early 2023, pharmacies were 90% compliant with their serialization obligations, according to ministerial data.
How to Comply with the Serialization Obligation?
To comply with drug serialization obligations, pharmacists must follow these steps:
- undertake registration steps directly on the France MVO website;
- connect to the medicines verification directory;
- deactivate unique identifiers of boxes.
Read also: “Pharmacy Compliance with Drug Serialization”
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Sources:
Official Bulletin Health - Social Protection - Solidarity No. 2023/7 of April 17, 2023, page 113
Law adapting to European legislation No. 2023-171 of March 9, 2023, article 28