AIFA approved the document containing the provisions required by art. 2 of Ministerial Decree of 2 August 2019, Criteria and procedures according to which the Italian Medicines Agency negotiates prices of medicines reimbursed by the National Health Service (OJ No. 185 of 24 July 2020), for the submission of applications for negotiation.

In view of the need to provide stakeholders with a suitable transition period for the compilation of the new dossier, also considering possible pricing and reimbursement applications already at an advanced stage of elaboration and submitted in accordance with the previous model, it is acknowledged that the criteria and procedures set out in the new guidelines will apply starting from 1 March 2021. A dedicated interface for the online filing of dossiers will also be available shortly. Information will be provided once the testing phase is complete.

The new guidelines have been produced also taking into account a specific public consultation: inputs collected during the public consultation will be available for the next thirty days at the following link