The Italian Medicines Agency has published on its institutional portal the simplified procedure for negotiating the price and reimbursement of parallel imported medicines (Directorial Determination no. 357/2021).

The new procedure, adopted in accordance with current legislation and relevant jurisprudence on the subject, pursues cost savings in Italy for this category of medicines in an innovative way with the introduction of possible automatisms in the definition of prices and a drastic reduction in the timeframe for the conclusion of the reimbursement procedure.

To this end, unambiguous and transparent criteria have been established for a simplified negotiation as an alternative to the ordinary one, aimed at fostering price control and achieving an immediate reduction in expenditure for both the NHS and citizens.