New application form for listing of medicines under Law 648/96

AIFA has published a new application form for the inclusion of medicines in the list pursuant to Law 648/96; there are some changes compared to the previous form

Here is the extra information required:

Authorisation status of the medicinal product in Italy and abroad;
Reimbursement scheme for the medicine in Italy;
Specify whether it is a rare disease or an orphan drug for the indication or for a different indication;
Willingness of the pharmaceutical company to provide the medicine free of charge pursuant to the Ministerial Decree of 7 September 2017 (mandatory)

In general, the instructions provided for compilation are much more precise and require more specific information. Delivery of the hard copy of the dossier to AIFA is no longer necessary

There are still no clarifications regarding the procedural modalities for the 648 negotiations under the Interministerial Decree of 2 August 2019. Authorised applicants remain those foreseen by 648: Patient Associations, Scientific Societies, Health Authorities, Universities, clinicians or upon indication of AIFA's CTS.

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