LIFE SCIENCES | New AIFA 2026 Guidelines on SOP and OTC relased

The new AIFA Guidelines of 23 February 2026 on the definition and classification of self-medication medicinal products (OTC) and medicinal products not subject to medical prescription (SOP), adopted by AIFA through Decision No. 166/2026, apply as of 25 March 2026 and replace the previous implementing guidance concerning the supply regime of non-prescription medicinal products, updating the interpretative framework relating to classification for supply purposes. The main innovations consist of a more rigorous and systematic definition of the substantive criteria.

With regard to composition, active substances must be of well-established medical use, widely used in therapy, and supported by proven efficacy and safety; as a general rule, a marketing period of at least five years in an EEA Member State (including the United Kingdom, limited to data accrued up to the end of 2020) is required, sufficient to adequately characterise the benefit/risk profile.

As for therapeutic indications, OTC medicinal products must be intended for the symptomatic treatment of mild and transient conditions that can be identified and managed by the patient without medical intervention. With respect to routes of administration, the parenteral route is excluded and, more generally, any route requiring the intervention of a healthcare professional.

In terms of posology and duration, a wide margin of safety is required with respect to the single dose, the maximum number of daily administrations, the maximum daily dose, the total number of doses per pack, and the duration of treatment, which must be short and clearly indicated.

Finally, the risk assessment is strengthened and must structurally address the risk of misinterpretation of symptoms and delayed diagnosis, inappropriate use or overdose, development of tolerance or dependence, interactions, risks in specific populations, serious or not rapidly reversible adverse reactions, and misunderstanding of the dosing regimen, supported by a critical review including pharmacovigilance data.

Newsletter n. 116 – March 2026