Italy · Italian Medicines Agency · New drugs
Review target
90 days
law
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
€16,309
From April 2026
A medicine already authorised in Italy can be extended to other EU countries, with AIFA as reference member state. AIFA prepares or updates its assessment report within 90 days, the other countries review it in 90 days, and AIFA updates the Italian authorisation within 30 days of consensus. A medicine with an Italian national authorisation that the holder wants authorised in other EU countries. A switch of reference state to Italy is also possible.
The official review target is 90 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The mutual recognition, italy as reference state, full or well-established use dossier: one strength, form and pack is €16,309 for From April 2026.
1. Ask AIFA to act as reference state; 2. Assessment report prepared or updated (90 days); 3. Review by concerned countries (90 days); 4. Disagreement procedure (if needed); 5. Italian authorisation updated (30 days).
Outcome: Recognition of the Italian authorisation by the concerned countries and, where needed, an updated Italian authorisation.
Legal basis: Legislative Decree 219/2006, articles 41, 42 and 44, implementing Directive 2001/83/EC.
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 210 days end to end with the official step targets. 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
| Decisionlaw. Update of the Italian authorisation after consensus. | 30 days |
| Review targetlaw. Assessment report prepared or updated by AIFA. This is an official target, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Mutual recognition, Italy as reference state, full or well-established use dossier: one strength, form and packApplication · From April 2026 | €16,309 |
| Mutual recognition, Italy as reference state, generic or hybrid dossier: one strength, form and packApplication · From April 2026 | €6,327 |
Other routes in Italy: National marketing authorisation (full dossier), National marketing authorisation for a generic or hybrid medicine, National marketing authorisation (well-established use, bibliographic), Decentralised 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.