February 9, 2025 represents a crucial date for Italy in the area of drug traceability. As of this day, in fact, our country will also have to comply with the Delegated Regulation (EU) 2016/161, which establishes the obligation to affix on the packaging of medicines:
– a unique identification code in Datamatrix format
– a tamper-proof seal to ensure the integrity of the product
These measures have already been in place in most of the European Union since Feb. 9, 2019, but Italy, along with Greece and Belgium, has benefited from a six-year derogation by virtue of existing national anti-counterfeiting systems that the European Commission considers sufficiently secure.
Last September, our government asked to extend again (until Feb. 09, 2028 ) the date for compliance with the new tracking system, but DG Sante (the EC’s Directorate-General for Health and Food Safety) reiterated the legally binding obligation to comply by Feb. 9, 2025 forcing our country to scramble before incurring infringement proceedings.
No more time
The Law No. 15 of February 21, 2024, in fact committed the Italian government to adopt all necessary legislative decrees to harmonize Italian legislation with the European Regulation by providing pharmaceutical companies a congruous amount of time to update their technological processes.
However, the draft implementing decree was not approved by the two chambers until late 2024, and many technical specifications are still unknown. With less than a month to go before the deadline the general legislative decree adapting the national legislation and the implementing decrees establishing the operational aspects are still missing: too little time left for pharmaceutical companies to adapt, complained the associations Farmindustry and Egualia – and later also Assoram – in an alarming statement published in December.
The draft decree
The draft legislative decree approved by both chambers of Parliament adapts Italian legislation to Delegated Regulation (EU) 2016/161 by clarifying obligations for manufacturers, distributors and pharmacies to ensure the traceability of medicines.
As of Feb. 9, 2025, all prescription medicines will have to carry a unique identification code, coded in Datamatrix format, and an anti-tampering system conforming to European standards.
Datamatrix
Datamatrix is a type of two-dimensional barcode that allows large amounts of information to be stored in a very small space. A crucial element of this tool is the built-in redundancy, which ensures high reliability. In fact, even if the code suffers partial damage, the Datamatrix can still be read correctly thanks to its error correction system, based on advanced algorithms.
In addition, the Datamatrix is designed to be extremely versatile and easy to read. Optical readers can scan it from any angle and under varying lighting conditions, without compromising data accuracy. This is a very practical feature in industrial and healthcare environments, where speed and efficiency are essential.
Finally, its ability to adapt to very small surfaces also makes it suitable for applications on compact packages, such as drug blisters or medical devices.
Responsibility
To ensure the authenticity of products,manufacturers will be responsible for applying these security devices to the packages, while wholesalers and pharmacies will have to verify their validity along the supply chain, all the way to patient dispensing. Verification of the unique code will make it possible to ascertain the origin of the drug and report any anomalies or suspicions of counterfeiting.
The national repository
A central element of the decree is the establishment of a “National Archive” to manage information related to unique identifiers and tamper-resistant systems. This repository will be managed by the State Mint and Polygraphic Institute, under the supervision of the Ministry of Health and Aifa.
It will be a point of reference to collect data on the traceability of medicines and to enable immediate verification of their authenticity.
Transition period
To accompany the industry in implementing the new regulations, the decree provides for a stabilization perioduntil 2027. During this phase, verification and registration operations will be monitored to ensure a smooth transition and allow for the adaptation of technological infrastructure.
In addition, it will be permissible to sell medicines produced before Feb. 9, 2025 until the expiration date, even if they have the previous pharmaceutical stamp.
For those who do not comply with the new provisions, there are administrative penalties, with fines of up to 140,000 euros in case of failure to apply the identifiers or the tamper-resistant system, or for omissions in the verification and reporting of data on the drugs distributed.
