The traceability project put in place by the Italian MoH is an instrument to uniquely identify every single package of a medicinal product in the distribution channel, with the purpose to protect companies from possible frauds and patients from possible health dangers. Traceability is also indispensable to monitor the supply of medicines to hospitals and pharmacies and the trend in medicinal products request and consumption in our country. In the end, it is a fundamental tool for pharmacovigilance, as it allows MAHs to know all movements of medicines packages on the market.
The optical sticker (bollino) is the main instrument on which the traceability project is based: it is a peelable sticker that contains (in words and barcodes) the main information of the medicinal product such as name, pack size, MA number and MAH name along with an assigned code which is different for each package.
The first step of the traceability transmission is managed by the traceability responsible person appointed at the MoH who takes care of the transmission of the information relevant to the movements of the boxes, the “bollini” wasted during the manufacturing process and stocks sold to the National Health System (NHS), to the Ministerial database, known as NSIS.
In addition, some aspects linked to the governance of the medicinal products in Italy have been transferred from the Italian MoH to AIFA, for the purpose of monitoring pharmaceutical expenditure relevant to medicinal products reimbursed by the NHS (i.e. A or H class medicinal products). This leads to the second step: the MAHs can have full access to the traceability data transmitted to the NSIS database through a specific application of the AIFA portal.
A monthly check performed by the MAH is important for the following reasons:
- in order to guarantee the availability for AIFA of the correct and complete data relevant to the supply of medicinal products marketed in Italy, which are used by the authority for the evaluation of many procedures, such as P&R negotiation processes, balance procedure, etc.
- in order to have the opportunity to promptly integrate/modify the data already transmitted. The data already transmitted through the NSIS can be amended or integrated within 2 months subsequent to the month of reference free of charge. After such deadline the possible amendment requires the MoH involvement and an administrative sanction.
Regulatory Pharma Net provides assistance in establishing the correct set-up of the transmission flow of the traceability data to MoH and AIFA and is available to provide any clarification and further information on the traceability project.