According to the Commission Delegated Regulation (EU) No 2016/161, new measures for the control of medicinal products in Europe have been adopted on February 9th, 2016. In the so-called “delegated act”, primarily technical details about the unique identifier and the anti-tampering device were introduced as the new safety features to avoid false medicinal products and to supervise the market.
Indeed, the Unique Identifier as a unique code, is imprinted in a 2D matrix code on each single pharmaceutical package.
Italy has already systems that can allow distributors/persons authorized/entitled to supply medicinal products to the public and to verify the authenticity of the product, identifying individual packs (thanks to the optical sticker), as well as devices that allow to check if the outer packaging has been tampered. For these reasons the implementation of the Regulation in Italy has been postponed to 2025.
According to the information available, for the time being, no procedures have been individuated for the transfer from the current optical stickers system to serialization foreseen by the Regulation (EU) No 2016/161.
What is the situation outside Italy? The Member States are working on the establishment of NMVO – National Medicines Verification Organization and on the setting of a national database in order to meet the deadline of the implementation of the Regulation (February 9th, 2019) and to be ready for integrating the codes on the European platform EMVO – European Medicines Verification Organization.
However, there are still common (i.e. implementation of FMD – Falsified Medicine Directive) and local issues (i.e. issue linked to the operational phase, such as the supervision of stakeholders, the supervision of repository system and the setting of procedures to be implemented for the investigation on falsified medicines) to solve out.
In this regard, some Agencies have set working groups in order to investigate on potential risks of the new procedure and plans/schemes to investigate false medicinal products (e.g. lists to be considered in order to make an investigation on false medicinal product).
Other Agencies are updating their web sites in real time to keep stakeholders aware about the regulations and requirements updates/local implementation.
Time is running out (less than 240 days)!
Regulatory Pharma Net is at your disposal to offer companies additional information and support on quality and regulatory aspects to be compliant to the Regulation (EU) No 2016/161.