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In brief

With Directorial Determination No. 357/2021, the Italian Medicines Agency (AIFA) adopted a new simplified procedure for negotiating the price and reimbursement of medicines placed on the market through parallel import procedure. Those intending to use the simplified procedure must send to the AIFA the dossier indicating the price proposal, reduced by at least 7% compared to the retail price of the corresponding product already marketed in Italy.


In particular, the new procedure establishes that, upon receipt the relevant application, the AIFA shall carry out an administrative check on the documentation transmitted and communicate to the applicant any further negotiating conditions required for the conclusion of the procedure. In case the importer accepts all the requested conditions, the proposal for eligibility to reimbursement is submitted to the approval of the AIFA’s Board of Directors, which is followed by the adoption of the relevant determination.

In specific cases, such as those where it is necessary to activate a monitoring register or a conditional access to the market, the AIFA may involve its Technical-Scientific Commission and Price and Reimbursement Committee in the procedure. Furthermore, whenever the relevant drug is included in the transparency lists, the price reduction cannot result in a retail price lower than that of the relevant reference price.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.