Edited by Paola Furiosi and Francesca Caliri
The counterfeiting of medicinal products has exponentially increased in recent years, representing both a serious risk to public health and a significant loss for pharmaceutical companies. To combat this phenomenon, which has also been exacerbated by the proliferation of eCommerce sites dedicated to the pharma sector, the provisions of Delegated Regulation (EU) 2016/161 (“Regulation“) will finally be applicable in Italy on February 9, 2025. This Regulation supplements Directive 2001/83/EC by establishing detailed rules on the safety features on the packaging of medicinal products for human use.
At the European level, pharmaceutical counterfeiting is regulated by Directive 2011/62/EU (Falsified Medicine Directive – FDM), which has provided for the establishment of end-to-end security and identification systems on each individual package of medicinal products. In implementation of the FDM, the Regulation stipulates that Italian pharmaceutical companies (i.e., those holding marketing authorizations – so called “AIC” -, as well as drug manufacturing sites) must apply security measures on the packaging, specifically:
- The Data Matrix 2D code, an identifier containing four data points (related to product code, serial number, batch number, and expiration date) inserted within a barcode on the packaging; and
- An anti-tampering device, to ensure the integrity of the package, which once opened cannot be resealed as originally (e.g., removable labels, adhesives, interlocking systems that damage the cardboard fibers once opened).
Verification of the authenticity of drug packages will be carried out at the time of delivery of the drug to the patient, when the pharmacist will have to scan the code and verify the data match in a national archive, managed by the National Medicines Verification Organization Italia (NMVO Italia), a nonprofit consortium company created ad hoc by associations in the pharmaceutical supply chain as the national body for verification of counterfeit medicinal products on Italian territory.
The new system will replace the current drug anti-counterfeiting system in Italy, namely the so-called “optical stamp.” Originally, Italian pharmaceutical stamps allowed for the optical reading of two codes bearing, respectively, information about the AIC number assigned by the Italian Drug Agency and a progressive number assigned by the Istituto Poligrafico e Zecca dello Stato when the stamps were printed. Since 2014, a barcode called “Data Matrix” has been affixed to the vignette, which combines the information of the two previous codes, simplifying the optical reading operation.
In Italy, therefore, the authenticity rules applicable to products that fall under the field of prescription-only medicines will change, enabling the establishment of a system that promptly flags and withdraws suspected counterfeit medicinal products from the market, initiating an investigation to determine their authenticity and preventing their distribution.
The goal of the legislation is to ensure, through the serialization of products, greater traceability of products throughout the drug supply chain, from the manufacturing stage to the moment of purchase by the consumer.
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