Distribution & Marketing of Drugs: Italy

Distribution

1. Preconditions for distribution

1.1 What are the legal preconditions for a drug to be distributed within the jurisdiction? Does the drug need to be licensed (authorised) for distribution? Are there exceptions or different categories such as compassionate use?

Drugs can be distributed in Italy provided that they are: 

• licensed by the Italian Medicine Agency (Agenzia Italiana del Farmaco, AIFA) (national procedure) as provided in Directive 2001/83/EC (implemented in Italy by Article 8 of the Legislative Decree No. 219/2006); or
• licensed pursuant to EC Regulation No. 726/2004 and 1394/2007 (mutual recognition procedure and decentralised procedure): all the procedural requirements listed in Article 28 of Directive 2001/83/EC (implemented in Italy by Articles 41–49 of the Legislative Decree No. 219/2006) apply; or
• licensed by the Italian Medicine Agency (Agenzia Italiana del Farmaco, AIFA) as parallel imported drugs pursuant to Ministerial Decree dated 29 August 1997 (see question 1.4).