An overview on the Italian Pharma & Medical Device regulation

Stefano Giberti and Erica Benigni provide a guide to the regulations in Italy on medicines and medical devices in the context of the National Health System (NHS). Specifically, here the points covered:

• Regulatory framework: competent authorities for authorisation and overview of on medicines, medical devices and borderline products;
• Clinical practice;
• Marketing authorisation;
• Amending authorisations;
• Recall – defective and unsafe products;
• Advertising and promotion; 
• Off-label use and unlicensed products;
• Forthcoming legislation and regulation: update and trends.

The full article can be downloaded through the link at the bottom of the page

Reproduced with permission from Law Business Research Ltd. This article was first published in Lexology GTDT – Pharma & Medical Device Regulation 2023. For further information, please visit: https://www.lexology.com/gtdt