It was published in the Official Gazette the decree with which the Ministry of Health prevented dozens of drugsamong the most used by the Italians, they disappeared from pharmacies for a problem with the packaging. Italy had not implemented European legislation and this risked making pharmaceutical stamps unusable.
With the new decree, a transition process is started to the new system, that of Data Matrixwhich will be unified throughout Europe and will guarantee protection against the counterfeiting of drugs. The new rules will take effect immediately, but there will be no penalties before 2027.
What does the new drug decree say
The ministerial decree approved on March 6 but published in the Official Gazette only on April 10, has implemented the European legislation on the counterfeiting of the 2016 drugs. Starting from February, medicines have all a new univocal code to be identified. The legislation also provides for some changes to practice anti -counterfeiting current:
- All medicines must include a system against tampering;
- The packaging of drugs can be equipped with the new Matrix date;
- Pharmacies will have to equip themselves with systems suitable for reading the data matrix;
- The procedures for the establishment of a national drug archive will begin.
However, there is no haste. Giorgia Meloni’s government has obtained fromEuropean Union a two -year derogation from the date of application of the legislation provided for our country. The deadline to completely implement these changes is February 9, 2027. In this period there will be no sanctions for those who do not respect the new rules and old anti -counterfeiting methods, such as the pharmaceutical stamp, will still be valid.
What are the Matrix data
One of the focal points of this decree are the Data Matrix. It is two -dimensional codeswhich can resemble the QR code, and which will replace the pharmaceutical stamp as a method of recognition of drugs and as an anti -counterfeiting system. Each date Matrix must be applied by the manufacturers on all packs, and contain:
- the product code (Gin);
- the serial number;
- the AIC code (authorization to make on the market);
- the number of manufacturing lot;
- the expiry date.
The main difference between the Matrix data and the pharmaceutical stamp, however it is that the first is part of a European system that protects the entire EU from counterfeiting of drugs. The stamp was an Italian invention, which on the one hand allowed our country to effectively contrast the counterfeiting, on the other hand it put it in an uncomfortable situation.
Because Italy has risked remaining without drugs
When, in 2016, the EU developed anti -counterfeiting legislation, almost every European country had a serious problem of fake drugs. Among the exceptions, together with Greece, there was Italy. A few years earlier, just to resolve the question, our country had implemented the pharmaceutical stamp, bringing the counterfeiting of drugs in a few years to a marginal percentage of the market.
The objectives of the European legislation were two: to contrast the counterfeiting and create A uniform system in Europe. Wanting to concentrate mainly on the first, Brussels granted Italy a period of derogation, in which our country was able to ignore the European rules by virtue of the results it had obtained in the fight against counterfeiting of drugs.
However, the derogation expired in February 2025 and our country, in almost 10 years, had done nothing to adapt. Only thanks to the concession of this further delegationgranted only after adaptation to European standards, dozens of drugs have not disappeared from pharmacies even if their packs were not in accordance with.
