The fight against counterfeit medicines in Italy
Published on 20th Feb 2025
The Italian legislative decree implementing Regulation (EU) 2016/161 enters into force
Counterfeit medicines pose a serious threat to public health as good manufacturing practice and good distribution practice standards are not observed. It is estimated that 1% of medicines sold in the EU are fake. In other parts of the world, the percentage of counterfeit medicines can be as high as 30%, especially among life-saving drugs.
Delegated Regulation (EU) 2016/161 lays down specific rules on the safety features to be detailed on the packaging of medicinal products.
The regulation, already applicable in most of Europe since 9 February 2019, aims to prevent falsified medicines from entering the distribution chain. Italy, having benefited from a derogation due to the existence of the national drug identification and traceability system, has adapted its existing national legislation in line with the provisions of the regulation with Legislative Decree no. 10 of 6 February 2025, which entered into force on 8 February 2025.
Traceability and anti-tampering system
Article 3 of Legislative Decree no. 10/2025 provides for the introduction of a unique identifier encoded in a two-dimensional machine-readable code that the manufacturer will have to affix to the packaging of prescription-only medicinal products (excluding those listed in Annex I to the regulation) and non-prescription medicinal products listed in Annex II to the regulation. This identifier, which will enable the individual packaging of a medicinal product to be identified and verify its authenticity, consists of the product code, batch number, expiry date, serial number and, if required by the Member State in which the product is to be placed on the market, a national reimbursement number.
In addition, it is compulsory to apply the anti-tampering system on the packaging of all medicinal products authorised in Italy, with the exception of those listed in Annex I of the regulation, in order to check whether the packaging has been tampered with.
In the event of non-compliance with the new provisions, all obliged parties under the legislative decree are subject to a strict penalty system, which will be updated every two years.
National archive
The new medicine tracking system provides for the establishment of a national archive containing information on the safety characteristics of the medicines, which will interact with the central database according to the provisions contained in the decree of the Minister of Health, to be adopted in agreement with the Minister of Economy and Finance, within 60 days of the new legislative decree coming into force, and therefore by 9 April.
Manufacturers, subjects authorised or entitled to supply medicinal products to the public and wholesalers are obliged to verify the authenticity of the unique identifier by comparing it with the unique identifiers listed in the national archive, and to activate procedures for deactivation of the identifier code in case of suspected falsification or tampering, preventing the distribution or supply of the medicinal product to the public. In cases of suspected tampering with the packaging or falsification of a medicinal product, manufacturers, wholesalers and subjects authorised or entitled to supply medicines to the public have an obligation not to supply it and to inform the competent authorities immediately.
Transitional period
Article 13 of Legislative Decree 10/2025 expressly provides that medicinal products intended for sale in Italy, which were included in batches issued before 9 February 2025 and on which the pharmaceutical seal has been affixed, may be placed on the market, distributed and supplied to the public until their expiry date without the need for repackaging or relabelling.
In order to allow the parties in the distribution chain to adapt to the changes introduced by the legislation, the law provides for a transitional period from 9 February 2025 to 8 February 2027, during which it will be permitted to ensure the traceability of medicines and the prevention of tampering by means of the pharmaceutical seal. To monitor progress in the implementation of the traceability and tampering-prevention system, a special technical committee will be established during this period. In addition, during the stabilisation period, a milder sanctioning system is envisaged, partially exempting those affected from the administrative sanctions that will come fully into force when the new legislation is fully applicable.
Osborne Clarke comment
The entry into force of Legislative Decree no,10 of 2025 represents a major step forward in the fight against counterfeit medicines and contributes to a safer and more transparent pharmaceutical system.
On the one hand, the new measures provide effective tools to ensure the safety of medicines and the protection of public health (together with those on the protection of pharmaceutical trade marks and packaging design).
On the other hand, the new system has taken into account the critical issues raised by stakeholders, particularly with regard to the costs and time needed to adapt production lines to the tamper-resistant system, with possible effects on the availability of medicines. It is hoped that the transitional period will allow operators in the sector to adapt effectively to the new measures, within the framework of an efficient collaboration between the competent authorities and private stakeholders.
