National procedure
For products intended for the Italian market only, filed directly with the Italian authority.
Marketing authorisation
The route to an Italian authorisation
The right regulatory route depends on where your product is already authorised, on the type of application and on your commercial timeline. We identify the route first, then build the project around it.
Regulatory routes
Which procedure applies to your product
Mutual recognition (MRP)
Extension to Italy of an authorisation already granted in another EU member state.
Decentralised procedure (DCP)
Simultaneous application in Italy and other member states, with Italy as concerned or reference state.
Parallel import authorisation
Specific authorisation for medicinal products already authorised in another member state and imported into Italy.
What you receive
Deliverables of a registration project
- Regulatory feasibility report and recommended route
- Gap analysis of the existing dossier
- Project timeline with the key procedural milestones
- Prepared and validated submission package
- Management of the entire procedure with the authority
- Approved Italian SmPC, package leaflet and labelling texts
- Handover file with all post-approval obligations
Registering more than one product?
Portfolio programmes are planned as a whole: shared timelines, consolidated status reporting and a single point of contact for every product in the plan.
Start your Italian registration
Tell us what you want to register and when you want to be on the market.