The traceability of medicines has been designed to collect information regarding medicinal packs placed in the distribution system into a centralized database.

The marketing authorisation holder or distributer is obliged to affix a special anti-fraud sticker to each pack, indicating the marketing authorisation holder name, the product name and serial number of the sticker.

This permits the National Health Service and the Treasury to set out a suitable procedure to combat potential fraud, which is to the detriment of public health, plus the prevention and suppression of any illegal activities and the monitoring of the supply of drugs, whether in hospitals, local pharmacies or for direct distribution. It also allows for a more effective national program of pharmacovigilance and, ultimately, provides a more accurate view of the consumption of medicines and hence the development of a prescriptive system increasingly able meets the needs of the consumer.

Di Renzo Regulatory Affairs is equipped and authorized to proceed with the transmission of the data regarding the movements of pharmaceutical packaging to the appropriate database by sending a XML file, as required by the guidelines and the technical specifications.

This service is particularly directed to MA holders that have manufacturing sites and warehouses abroad.