Italy · Italian Medicines Agency · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
7 requirements
Application fee
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AIFA classifies a medicine as OTC (self-medication, directly accessible to customers) or SOP (non-prescription but with the pharmacist's involvement). The request can be made with the marketing authorisation application or later through a variation. New national guidelines adopted in 2026 set the criteria. A medicine with a well-known active substance, generally marketed for 5 years in the EEA, for short-term treatment of mild and transient disorders, with no packs reimbursed by the national health service.
1. Request with the authorisation application; 2. Or a later variation; 3. Centrally authorised medicines; 4. AIFA assessment; 5. Classification decision.
Outcome: Supply classification as OTC (class C-bis) or SOP, recorded in the authorisation.
Legal basis: Legislative Decree 219/2006, articles 87, 96 and 98; AIFA OTC and SOP guidelines (Presidential Determination 166/2026).
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Italy: Parallel import authorisation. See all routes on the Italy page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.