From 9 February 2025, Italy too will be interconnected with the major European hub for verifying the authenticity of medicines before they are dispensed to patients.

Our country, together with Belgium and Greece, has taken advantage of a six-year derogation for the adaptation of the drug traceability system to the standards provided for by the European Directive 2011/62/EU – “Falsified Medicine Directive” supplemented by the Delegated Regulation (EU) 2016/161 of the European Commission, by virtue of the presence in our system of the so-called “vignino system” particularly efficient and structured for the traceability and control of drugs, based on the single national database and the stamp issued by the Istituto Poligrafico e Zecca dello Stato.

From 9 February 2025, Italy too will be interconnected with the major European hub for verifying the authenticity of medicines before they are dispensed to patients.
Our country, together with Belgium and Greece, has taken advantage of a six-year derogation for the adaptation of the drug traceability system to the standards provided for by the European Directive 2011/62/EU – “Falsified Medicine Directive” supplemented by the Delegated Regulation (EU) 2016/161 of the European Commission, by virtue of the presence in our system of the so-called “vignino system” particularly efficient and structured for the traceability and control of drugs, based on the single national database and the stamp issued by the Istituto Poligrafico e Zecca dello Stato.

The “new” European legislation, operational as of 9 February 2019 in all other Member States plus Iceland, Liechtenstein and Norway, envisages the affixing of a unique two-dimensional barcode, known as “Datamatrix 2D”, on drug packages and the implementation on them of an anti-tampering device to guarantee their integrity and non-compromise. The system will thus be based on a European interconnection of drug data to facilitate the free movement of medicines in the EU area, in a system aimed at protecting the health of patients.
The Council of Ministers of 30 August 2024 examined the legislative decree for the harmonisation of national legislation with European standards, introducing new obligations for the dispensing of prescription drugs, applicable to the entire drug supply chain: from manufacturers, wholesalers and distributors to pharmacists.

In particular, manufacturers who hold the marketing authorisation for drugs will generate the identifier and enter it into the single national archive linked to the European database. The identifier will be verified at each subsequent step within the supply chain; in fact, wholesalers and distributors will have to verify the unique code by comparing it with those in the system and consider it authentic only if they find a match in the national and European archives. The last check that the medicine undergoes, before reaching the patient’s hands, is carried out by the pharmacist, who must validate and remove the code at the time of dispensing after comparing it with the identifiers in the system. If the unique code is not present in the records, one could be faced with a counterfeit medicine.

Outside the ordinary process, the various operators will only be able to remove the code in the strict cases provided for by the regulations, including, medicines distributed outside the European Union or, medicines that cannot be put back into the sales stock or destined for destruction or samples requested by the competent authorities.

The decree also deals with the identification of sanctions for non-compliance with the regulation, which, to date, seems to have a considerable impact on the activities of distributors and pharmacists and for which, at the current state of the art, several critical issues are already emerging:

• the integration and dialogue of the databases, the national one managed by the consortium company “Nmvo – National Medicine Verification Organisation” set up in January 2024 by all players in the drug supply chain and the European one, “European Medicines Verification Organisation”. A further connection is planned with the “Nsis – New Health Information System”, a database with which the systems of retail pharmacies will interface, which in turn will have to equip themselves with systems capable of interacting with the European Hub and with hospitals for drug decommissioning procedures.
• the provision of new optical readers, suitable for the new unique code, for pharmacists (old technological equipment will not be able to be decommissioned until the drugs in circulation with the “old sticker” are completely disposed of).
• the repeal by the Government of the current “vignette system” legislation to make way for the new “Datamatrix”.

More details will come with the technical specifications that the Ministry of Health will issue within 30 days of the government decree coming into force. For the time being, the first deadline set by the decree is 9 November 2024, when holders of marketing authorisations for drugs issued before the decree came into force will already have to have submitted an application to AIFA to adapt their authorisation to the new drug traceability system.

unyer Working Group Health Care & Life Science

Roberta Pirola
Partner

Alberto Santi
Partner