+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Drug traceability, antifraud stickers and serialisation

Drug traceability has been created in order to collect, in a centralised database, information regarding the packs of medicines placed within the distribution system. The legislation provides for that a special antifraud sticker is affixed on each pack indicating the name of the MAH, the product name and description, the progressive number of the pack, the MA number of the medicine pack represented by the letter A followed by 9 digits.

This allows the definition of increasingly appropriate procedures to contrast potential frauds to the detriment of public health, the National Health Service and the Tax Authorities, for the prevention and suppression of any illegal activities, and to monitor the supply of drugs to hospitals, pharmacies and direct distribution.

The traceability system also makes the national pharmacovigilance program more effective and provides a more accurate view of the consumption of drugs and, consequently, the development of a prescriptive system which is more suited to the needs of consumers.

Although Directive 2011/62/EU (Falsified Medicines Directive) and Regulation (EU) 2016/161, introducing European harmonised measures to fight medicinal product falsification have become effective, in Italy the use of antifraud stickers is still provided for. Italy has in fact obtained a timeline extension until 2025, as a system to monitor possible frauds is already in place.

Di Renzo Regulatory Affairs has a special unit that can assist pharmaceutical companies in the following steps:

  • Orders of antifraud stickers, pre-printing check, supervision of the shipment from the printers to the manufacturing site
  • Handling the collection of data regarding the used and discarded antifraud stickers
  • Transmission of the information concerning the handling of the packs to the database of the Ministry of Health via XML files, as provided for by the guidelines and the specifications of the Ministry of Health
  • Updating the database regarding the number of antifraud stickers still available to the company

Foto di: PublicDomainPictures da Pixabay