Chiara Pieve -

With Ministerial Decree of 11th May, 2018 published in the IOJ n.147 dated 27th June, 2018, some aspects linked to the governance of traceability have been transferred from the Italian Ministry of Health (MoH) to AIFA.

In particular, AIFA enabled access in the AIFA FRONT END portal relevant to the traceability in order to allow the MAHs to have full access to the traceability data transmitted to the central database of the Italian MoH (NSIS) including information about sender and receiver of the supplies of medicinal product in charge of Italian NHS.

In this regard, every Pharmaceutical Company should appoint a person responsible for the data control, authorized by the MAH to check the traceability data already transmitted to the NSIS (the central database of the Italian MoH) by the responsible person of traceability.

This periodic check by the MAH is important:

1. in order to guarantee the availability for AIFA of correct and complete data relevant to the supply of medicinal products marketed in Italy. In particular, for products reimbursed by the National Health System (i.e. A or H class medicinal products), AIFA can properly monitor the NHS pharmaceutical expenditure and implement any necessary balance procedure.

2. since the data transmitted through the NSIS by the responsible person of traceability data transmission can be amended or integrated within 2 months subsequent to the month of reference (if needed). As already indicated, amendments or integrations requested later than the 2 months period above mentioned implicate administrative penalties from 1.500,00 to 9.000,00 €.

Regulatory Pharma Net is available to support pharmaceutical companies in the management of the procedure.

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