Anti-counterfeiting of medicines: The new provisions of the Decree implementing delegated Regulation on falsified medicines

Among other things, the Decree: (i) empowers the Ministry of Health to specify the characteristics of the new devices introduced with the Regulation with the aim to contrast the counterfeiting of medicinal products i.e. the unique identifier and the anti-tamper device; (ii) establishes the sanctions for the breach of the Regulation; and (iii) provides for a transitional regime to allow pharmaceutical companies to properly adopt the new provisions and provide their products with the new unique identifier and anti-tamper device.

Although the new Decree has formally implemented the Regulation, with the transitional provisions Italy has substantially postponed for two years the implementation of the unique identifier code and of the anti-tamper device. Basically, the Decree allows manufacturers to place on the market medicines with pharmaceutical stamps in accordance with to the provisions of the Italian Medicines Code, until February 2027.

Moreover, the Decree still provides a very high-level regulation of this topic, as most of the operational rules have been delegated by the Decree to 13 (!) ministerial decrees to be issued in the following months.

The obligations of the Regulation

The Regulation implements the provisions of the Directive 2011/62/EU, known as the “Falsified Medicines Directive”, by introducing new tools to prevent falsification of medicinal products. The Regulation applies to prescription-only medicines whose packaging allows their authenticity to be verified^[1] and exceptionally to certain non-prescription medicines.^[2]

The Regulation introduces new provisions that will have a major impact on the EU’s fight against the falsification of medicinal products placed on the European market. Among the most important provisions, the Regulation introduces a unique identifier which is the so-called “Data Matrix”, i.e. a code for the identification of medicinal products, encoded in a two-dimensional, machine-readable bar code consisting of a series of numeric or alphanumeric characters which are unique for each individual package of medicinal products. The manufacturer must print the Data Matrix code on the packaging of its products to enable the identification of the medicines. In addition to the unique identifier, the Regulation requires manufacturers to provide their medicinal products with an anti-tamper device to ensure that the packaging of the medicinal product is protected and cannot be opened without leaving obvious traces.

According to the Regulation, the subjects involved in the supply of medicinal products must comply with several obligations relating to the prevention of counterfeit medicines. If an entity becomes aware that one of its products has been tampered with or is non-authentic, it must: (i) immediately cease the supply of the product; (ii) inform the competent authorities; and (iii) deactivate the unique identifier. Manufacturers, wholesalers and subjects authorized to supply medicines to the public are therefore required to check the integrity of the anti-tampering device. The Regulation also introduces the European Medicine Verification System (Emvs) which is a new platform established at European level for archiving data related to medicines’ safety and authenticity. Marketing authorization holders (MAH) will have an obligation to integrate this data into the platform before the manufacturer places on the market or distribute a medicinal product; MAH also grants that the information on the platform is kept updated. The Emvs is accessible by manufacturers, MAHs, wholesalers and people authorized to supply medicinal products to the public.

The unique identifier and the anti-tampering device

Without prejudice to medicinal products marketed under the transitional regime of the Decree, all medicines falling within the scope of application of the Regulation and which are authorized in Italy as of February 9, 2025, must be provided with the unique identifier as well as the anti-tamper device.. Manufacturers, wholesalers and other subjects authorized to the supply of medicinal products must verify the authenticity of the unique identifier in accordance with the provisions of the Regulation and inform the authorities in the event of suspected tampering /falsification of the product. The Decree identifies the competent authorities in the territorially competent Region or Autonomous Province, the Italian Ministry of Health and the Italian Medicine Agency (“AIFA”), which is also the competent authority for investigating potential cases of counterfeit medicines, reimbursement matters, as well as for pharmacovigilance and pharmacoepidemiology.

In this regard, the Ministry of Health is empowered by the Decree to provide the technical specifications of the unique identifier system, taking into account the national reimbursement number or another national number identifying the medicinal product. The Ministry of Health must also specify the additional information that manufacturers of medicines can include (subject to AIFA authorization) in the two-dimensional bar code containing the unique identifier as well as the technical and graphic characteristics of the anti-tamper device.

Medicines that do not fall within the scope of application of the Regulation will continue to be marketed with the so called “pharmaceutical stamp” system in accordance with the provisions of the Italian Medicine Code^[3].

Procedures for new MAs and related adjustments

Once AIFA publishes operating instructions^[4], pharma companies will need to include information on medicine’s unique identifier and anti-tamper device in the application for the issuance of a new marketing authorization (MA) if the anti-counterfeiting devices have an impact on the primary packaging of the medicine, on its closure system or on the legibility of labelling information whether if they are affixed on the secondary packaging. For ongoing MAs procedures, companies will need to supplement the above information according to the procedure that AIFA will identify.

Moreover, MAHs will have to adapt the MAs issued prior to entry into force of the Decree by submitting a notification to AIFA^[5]. The notification is also mandatory if the anti-tamper device placed on the secondary packaging affects the legibility of the labelling information.

The National Archive on Medicines Safety Characteristics

The Decree establishes the National Archive which contains all information on the safety features of medicines. The Archive will transmit to the Central Database^[6] all data relating to the monitoring of the distribution and detection of expenditure borne by the National Health System (NHS). The Ministry of Health will define the obligations of certain economic operators (including pharmacists) to ensure the distribution monitoring and the detection of expenditure borne by the NHS. The Ministry of Health will also have to identify the modalities to allow subjects authorized to supply medicines to the public to interact with the Archive for verifying the deactivation of unique identifiers. The Ministry of Health will also be responsible for monitoring the operation of the Archive.

Sanction

The Decree provides administrative sanctions for the violation of the provisions of the Regulation, among which it provides fines:

• from EUR 10,000 to EUR 60,000 for each batch on the manufacturer who does not affix or does not activate the unique identifier code in accordance with the technical specifications of the Regulation or who includes information other than the unique identifier in the bar code without AIFA authorization. The same sanction shall be imposed on the MAH who place on the market a medicinal product without the anti-tampering device.
• from EUR 15,000 to EUR 80,000 for each batch on the manufacturer, wholesaler or subject authorized to the supply of medicinal products who places on the market, exports or supplies a medicinal product without checking the authenticity of the unique identifier or the integrity of the anti-tampering device.
• from EUR 20,000 to EUR 80,000 per batch on anyone who distributes or supplies to the public a medicinal product bearing a deactivated unique identifier or an activated one in case the Regulation requires it to be deactivated. The unlawful reactivation of the unique identifier entails a penalty between EUR 30,000 and EUR 140,000 per batch on the manufacturer, wholesaler or subject authorized to supply medicinal products to the public.
• from EUR 30,000 to EUR 140,000 per batch on manufacturer, wholesaler or subject authorized to supply medicinal products to the public who places on the market or exports a medicinal product when there is a suspect of tampering/falsification. The fine goes from EUR 20,000 to EUR 80,000 when these latter subjects do not inform the authorities of the suspected tampering/falsification.

Transitional Provisions

Finally, the Decree provides several transitional provisions aimed at allowing pharmaceutical companies that fall within the scope of the Regulation to properly adopt the new Regulation’s provisions. The Decree provides:

• that the batches of medicinal products released by February 9, 2025, can still be placed on the market and distributed with the pharmaceutical stamp on the outer packaging (without having to be relabeled or repackaged) until their expiry date.
• A “stabilization period” from February 9, 2025, to February 8, 2027, in which manufactures can still place on the market medicinal products with pharmaceutical stamp (which replaces the unique identifier and the anti-tampering device) if they comply with the provisions of the operating instructions that will be defined by the Ministry of Health.

[1] Safety features within the meaning of Directive 2001/83/EC, i.e. safety features that enable wholesale distributors and persons authorised or entitled to supply medicinal products to the public to: verify the authenticity of the medicinal product, and identify individual packs, as well as a device to verify whether the outer packaging has been tampered with.

[2] That is, omeprazole in 20 and 40 mg capsules.

[3] Legislative Decree no. 219/2006.

[4] with regard also to parallel import and distribution of medicines.

[5] Pursuant to Article 78 of Legislative Decree No. 219/2006.

[6] Article 5-bis of the Legislative Decree no. 540 of December 30, 1992.