AIFA — Italian Medicines Agency
Responsible for the regulation and supervision of medicinal products in Italy, including parallel import authorisations.
One of our three business lines
What parallel import is
The free movement of goods between member states is a founding principle of the European Union. Medicinal products fall under this principle, but they still require a specific authorisation before they can be placed on the market of each country.
Parallel import allows a medicinal product already authorised in one member state to be distributed in another without a new full approval. The practice is governed by Directive 2001/83/EC, requires authorisation from the national authority — AIFA in Italy — and must comply with local requirements, including labelling and product quality.
Products must originate from an EU country and remain subject to controls that guarantee their safety and efficacy. Parallel import supports competition and access to medicines at more competitive prices, within the boundaries set by European legislation and intellectual property law.
Regulatory framework
Who authorises what
EMA — European Medicines Agency
Manages the authorisation of medicinal products at European level and provides uniform guidance across member states.
Eligibility
Who may import
Pharmaceutical companies recognised by the Italian Medicines Agency and authorised distributors recognised at European level.
Quality
How we protect the product
- All products are shipped under temperature-controlled transport
- Packaging is produced to match the reference brand product
- Relabelling and repackaging are carried out by AIFA-authorised sites under GMP and GDP
- Marketing authorisations, packaging sites and leaflet changes comply with Italian pharmaceutical legislation (Legislative Decree 219/2006)
Published in the Gazzetta Ufficiale della Repubblica Italiana
Talk to us about parallel import
For product availability, supply enquiries and partnership opportunities.