Italy: Extension of the distribution of drugs throughout the Italian territory as of 30 March

In brief

Article 1, paragraph 224, of Law No. 213 of 30 December 2023 (the so-called Budget Law 2024), in order to ensure a more efficient access to medicines, establishes the obligation for the Italian Medicines Agency (AIFA) to update the hospital-territory continuity of care formulary ("PHT") by 30 March 2024.


Contents

Key takeaways

This update, which is to be repeated annually, identifies the binding list of medicines that, due to their pharmacological characteristics, can switch from the A-PHT classification regime, as per AIFA's determination of 29 October 2004 and subsequent amendments, to class A, as per Article 8, paragraph 10, of Law No. 537 of 24 December 1993. More specifically, we are switching from a regime that provides for the distribution of medicines only in hospital pharmacies or other public health facilities, or for the purchase by health authorities and subsequent distribution, upon reservation, in partner pharmacies, to a conventional regime that, instead, allows distribution in pharmacies open to the public.

In addition, on the occasion of the above-mentioned update, AIFA will also have to draw up a binding list of off-patent PHT medicines that can be assigned to conventional distribution through pharmacies open to the public.

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