Italy · Italian Medicines Agency · New drugs
Review target
180 days
law
Legal time limit
-
Not published
Steps
5
5 requirements
Application fee
-
Every newly authorised medicine, including those authorised by the European Commission, is placed automatically in class C(nn), a section for medicines not yet assessed for reimbursement. For EU authorisations, AIFA publishes the class and supply regime within 60 days. The company must report its prices before marketing and may then apply for reimbursement. Any medicine authorised through the EU central procedure or a national, mutual recognition or decentralised procedure that the company plans to market in Italy.
The official review target is 180 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Marketing authorisation granted; 2. Class C(nn) and supply regime published (60 days); 3. Price notice before marketing; 4. Reimbursement and price application (optional); 5. Reimbursement and price decision (180 days).
Outcome: Publication of the class C(nn) placement and supply regime. Optionally, a later reimbursement and price decision.
Legal basis: Decree-Law 158/2012, article 12 (converted by Law 189/2012); Decree-Law 269/2003, article 48, paragraph 33.
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 240 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. Publication of class C(nn) and supply regime after an EU authorisation. | 60 days |
| Review targetlaw. Reimbursement and price decision. The law sets 100 days for orphan and other priority medicines. This is an official target, not an actual review time. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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 procedure with Italy as reference member state, Mutual recognition or decentralised procedure with Italy as concerned member state, Parallel import authorisation, 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, Advanced therapy prepared on a non-routine basis (hospital exemption), State batch control of vaccines and other immunological medicines. 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.