Distribution & Marketing of Drugs 2nd Edition Global Guide

Pre-conditions for distribution

What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

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.

Exceptions

Parallel imported drugs must be licensed by the Italian Medicine Agency according to

Ministerial Decree dated 29 August 1997 (see Question 3).

Edited by Alison Dennis of Fieldfisher & Eric Stupp and Markus Schott of Bar & Karrer AG