Italy · Italian Medicines Agency · New drugs
Review target
-
Not published
Legal time limit
210 days
law
Steps
10
14 requirements
Application fee
€81,546
From April 2026
A national route for medicines whose active substances have been in well-established medical use in the EU for at least ten years. Published literature replaces the company's own preclinical and clinical studies. The same AIFA procedure and time limits apply. A known active substance with at least ten years of well-established medical use in the EU, for sale only in Italy.
The new authorisation, full or well-established use dossier (national procedure): one strength, form and pack is €81,546 for From April 2026.
1. Send the application; 2. Administrative validation (14 days); 3. First assessment (step I) (110 days); 4. Answers to the first list of questions (90 days); 5. Second assessment (step II) (50 days); 6. Answers to a second list of questions (if any) (30 days); 7. Final phase and product texts (50 days); 8. Committee opinion on supply and classification; 9. Authorisation decision; 10. Post-authorisation duties.
Outcome: A national marketing authorisation (AIC) with its supply regime and class C(nn), C-SOP or C-bis OTC, or a refusal. The applicant can object to a refusal within 30 days. Valid for 5 years.
Legal basis: Legislative Decree 219/2006, article 11, with articles 8 and 29 to 40.
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).
About 344 days end to end with the official step targets, of which up to 120 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Validationofficial guidance. Administrative validation of the application. | 14 days |
| Longest clock stopofficial guidance. Answers to the first list of questions are due in 90 days. Any extension normally cannot go beyond about 6 months counted from the first list of questions. | 183 days |
| Legal time limitlaw. The law sets 210 days from receipt of a valid application. Clock stops for questions are not counted. This is an official target, not an actual review time. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New authorisation, full or well-established use dossier (national procedure): one strength, form and packApplication · From April 2026 | €81,546 |
Other routes in Italy: National marketing authorisation (full dossier), Decentralised procedure with Italy as reference member state, Mutual recognition procedure with Italy as reference member state, Mutual recognition or decentralised procedure with Italy as concerned member state, Parallel import authorisation, National classification after authorisation (class C(nn)) and reimbursement application, Early access through the Law 648/1996 list, Early access through the AIFA national fund (5% fund), Compassionate use of a medicine under clinical investigation. 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 (34 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.