Italian Medicines Agency Agenzia Italiana del Farmaco

Generic medicinal products

Equivalent medicinal products

An equivalent medicinal product is a drug with active ingredient, pharmaceutical form, route of administration, release mode, dosage, number of dosing units and unit doses equal to an off-patent reference (“brand”) drug.
For the purposes of the definition of an equivalent medicinal product -introduced in Italy by Law 149 of 2005 with regard to prescription drugs – it must be considered that the various immediate-release oral forms are considered to be the same pharmaceutical form (Article 10(5)(b) of Legislative Decree No 219/2006).
The equivalent medicinal product is recognisable by the words “Equivalent medicine” on the package leaflet and on the outer packaging.

Equivalent medicinal products

When equivalent medicinal products are authorised and classified in class A (thus paid by the National Health Service), they may be included in the AIFA Transparency List. Medicinal products included in the transparency list in the same group shall be considered automatically replaceable, unless AIFA decides otherwise, based on technical and scientific reasons.
If the doctor’s prescription does not indicate that the prescribed drug is not replaceable, the pharmacist after informing the patient and unless otherwise requested by the patient, shall provide the lowest-price medicine.
If the doctor’s prescription indicates a non-replaceability or if the patient does not accept the replacement proposed by the pharmacist, the difference between the lowest price and the price of the prescribed drug is paid by the patient.

The inclusion of a medicinal product in the AIFA transparency list depends on technical and scientific evaluations that establish the fulfilment of the requirements of equal therapeutic efficacy, prescription appropriateness and economic sustainability of pharmaceutical expenditure for the National Health Service, on the basis of predefined criteria (see AIFA Resolution 166/2021 “Definition of the criteria for inclusion in the transparency list”).

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