Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA Notes

AIFA Notes

AIFA Notes are the regulatory tool that defines the therapeutic indications for which a certain medicinal product can be charged to the National Health Service (NHS).

The Notes can be introduced in three cases:

  • when a medicinal product is authorized for different clinical indications, of which only some are for relevant pathologies;
  • when a medicinal product is aimed at preventing a risk that is significant only for one or more population groups;
  • when a medicinal product is suitable not only for uses of documented efficacy, but also for improper uses.

In these cases, through the Notes, AIFA identifies, among all the indications for which a medicinal product is authorized, those to be charged to the NHS from a public health perspective, thus orienting therapeutic choices towards better efficacy and greater safety of use.

AIFA Notes therefore represent the regulatory tool aimed at guaranteeing an appropriate use of medicinal products, directing the prescribing activity of doctors on the basis of the evidence in the literature, without however interfering with the doctor's freedom of prescription.

AIFA Notes



Introduced in 1993 following the establishment of the new Therapeutic Formulary of the National Health Service and originally conceived as a tool for governing pharmaceutical expenditure, the Notes have progressively become a means of ensuring the appropriateness of use of medicinal products, orienting, in some cases, the therapeutic choices in favor of more effective and tested molecules.

The appropriateness of the prescriptions does not only concern Italy but is a concern present all over the world. Different nations have therefore taken different ways to try to promote the correct use of medicinal products. Italy and France preferred to adopt the instrument of the Notes. Other countries, such as Great Britain and the United States, make great use of the Guidelines instead.

The Guidelines start from the clinical case and propose possible therapeutic paths from time to time. Conversely the Notes start from the medicinal product, indicating for which pathologies and under which conditions its use is recognized as eligible for reimbursement by the National Health Service.

The two systems, however, are not to be considered one alternative to the other, as Notes and Guidelines can be used in a complementary way.

When prescribing, the physician should indicate the number of the Note for that medicine on the prescription. In this way he declares that the conditions for reimbursement provided for in the Note are met.

Some Notes provide, as a greater guarantee of diagnostic-assistance appropriateness, that the prescription of particular medicinal products takes place on the basis of the diagnosis and preparation of an AIFA therapeutic plan issued by specialist centres identified by the Regions. If the prescribed medicinal product, in order to be eligible for reimbursement, is subject to diagnosis and a therapeutic plan by a specialist centre, a copy of the plan should be sent to the General Practitioner and to the Pharmaceutical Sector of the ASL of residence of the patient. The specialist is therefore required to prepare the treatment plan, but the patient can obtain the prescription for the medicine from the general practitioner.

The process of reviewing and updating the Notes takes place continuously in order to reflect new scientific evidence and to overcome any critical issues encountered in the application field, making this regulatory instrument more flexible in response to the needs of daily medical practice on the national territory.

Currently there are 34 Notes, compared to the original 59 of 1993. Over time, the Notes have undergone important revisions, taking into account the effectiveness of individual medicinal products in different pathologies, the possible reactions to treatments, but, above all, the evidence of the most recent scientific studies.

Some medicinal products, previously covered by a Note, have been directly admitted to class A without reimbursement limitations, while others have passed from class C (at the expense of the citizen) to eligibility for reimbursement at the expense of the NHS only for the cases provided for in the relevant Note.

With the work of updating, some texts of the AIFA Notes have been replaced with structured modules called AIFA Therapeutic Plans template (former Notes) and represent a prescriptive guide based on scientific evidence.

Monitoraggio delle Note AIFA

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