AIFA (Agenzia Italiana del Farmaco, the Italian Medicines Agency) has announced an important consultation for the second half of September.
The consultation will allow general comment on the implementation of requirements in the recently-approved law “Criteria and methods with which the Italian Medicines Agency determines, through negotiation, the prices of drugs reimbursed by the National Health Service”. The consultation will be specifically on “Guidelines for compiling the Dossier to support the request for reimbursement and price”, i.e. the requirements for pricing and reimbursement submissions in Italy.
UPDATE: The consultation is now live, find out more in the AIFA press release.