Italy · Italian Medicines Agency · New drugs
Review target
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Not published
Legal time limit
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Not published
Steps
5
6 requirements
Application fee
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An importer can bring into Italy a medicine authorised in another EU or EEA country when an analogous medicine is already authorised in Italy. AIFA grants a parallel import authorisation through a simplified procedure and gives each imported pack its own AIC code. A medicine with a valid authorisation in the country of origin that is identical or essentially similar to a medicine authorised in Italy. Centrally authorised medicines follow EU parallel distribution instead.
1. Apply for the parallel import authorisation; 2. AIFA check of the conditions; 3. Authorisation and pack code; 4. Centrally authorised products (alternative); 5. Notice before distribution (45 days).
Outcome: A parallel import authorisation (AIP) with a specific AIC code for each imported pack.
Legal basis: Legislative Decree 219/2006 (article 99 and article 158, paragraph 9) and the Ministerial Decree of 29 August 1997.
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 45 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
| No time targets published. |
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, Classification as a non-prescription medicine (OTC or SOP), 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 .
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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.