Italy · Italian Medicines Agency · Vaccines
Review target
60 days
law
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
Before distribution in Italy, each batch of live vaccines, vaccines for children and risk groups, vaccines used in collective programmes and some new immunological medicines goes through state control. The National Institute of Health (ISS) completes the control within 60 days of receiving the samples, and AIFA issues the batch release certificate. Every batch of a covered vaccine or immunological medicine before distribution, unless another EU country or an agreement partner has already controlled the batch.
The official review target is 60 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Samples and documents sent; 2. Check for an existing EU control; 3. Control by the National Institute of Health (60 days); 4. Batch release certificate.
Outcome: A batch release certificate that allows the batch to be marketed.
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 60 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
| Review targetlaw. Control by the National Institute of Health from receipt of samples. This is an official target, not an actual review time. | 60 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Italy: 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.