The traceability of medicines has been created in order to collect, in a centralized database, information regarding medical packaging placed within the distribution system. The MA holder or the licensee must affixed a special antifraud sticker on each pack indicating the name of the MAH, the product name, the sequence number of the sticker, the MA number and the description of the package.
This consents to an ever increasingly appropriate procedure to counter potential fraud 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.
It also gives rise to a more effective national pharmacovigilance program and provides an increasingly more accurate view of the consumption of drugs and, consequently, the development of a prescriptive system which is ever more suited to the needs of consumers.
Di Renzo Regulatory Affairs is able to assist pharmaceutical companies in the following phases:
- Ordering antifraud stickers, pre-printing check, supervising the shipment from the printers to the production site
- Handling the collection of data regarding the used and discarded antifraud stickers
- Transmission to the database of the Ministry of Health of the information concerning the movements of the packs via XML format as required by the guidelines and the specifications of the Ministry of Health
- Updating the database on the number of antifraud stickers remaining with the company