1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction?
Drugs can be distributed in Italy if they are either:
- Licensed by the Italian Medicine Agency (Agenzia Italiana del Farmaco) (which involves a national procedure) as provided in Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive) (implemented in Italy by Article 8 of the Legislative Decree No. 219/2006).
- Licensed according to:
- Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMA Regulation) (which is a mutual recognition procedure); or
- Regulation 1394/2007 on advanced therapy medicinal products and amending the Code for Human Medicines Directive and the EMA Regulation (which is a decentralised procedure).
All the procedural requirements listed in Article 28 of the Code for Human Medicines Directive (implemented in Italy by Articles 41 to 49 of the Legislative Decree No. 219/2006) apply.