Legal & Regulatory > Italy

The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In Italy, the use of recreational cannabis is prohibited under Presidential Decree no. 309/1990 (the “Presidential Decree”).  However, it is possible to use cannabis for medical purposes.  Indeed, the Decree of the Ministry…

The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. Are there proposals for reform or significant change to the healthcare system? The most recent changes in legislation relate to the clinical trial sector, where Legislative Decree No. 52/2019 and the Decree of the MoH dated November 30, 2021, which was published…

All legal aspects surrounding patents & trademarks in Italian Pharma. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What are the basic requirements to obtain patent and trademark protection? The regulation of Italian patents and trademarks is mainly contained in the Industrial Property Code (Legislative Decree No. 30/2005, hereinafter “I.P.C.”). Some provisions on patents and trademarks are also…

 The low-down on the situation regarding product liability in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What types of liability are recognized in your jurisdiction? The Italian regulatory framework, with reference to the liability for defective products, consists of:    • Contractual liability, governed by article 1218 of the Italian Civil Code;  • Liability for defective…

The ins and outs of traditional medicines and OTC products in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? a. Medicinal products To obtain a marketing authorization for medicinal products through a national, mutual recognition or decentralized procedure, the applicant is always required to submit…

All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? Please refer to the answer to Question 2 in Chapter 1.   2. What is the authorization process for the…

Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Under Legislative Decree No. 211/2003 on the application of good clinical practice in the conduct of clinical trials of medicines,…

Regulatory, pricing and reimbursement overview in Italy – a legal guide. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What are the regulatory authorities with jurisdiction over drugs, biological, and medical devices in your country? In Italy, the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices are: • the Ministry of Health (“MoH”), which generally…

Managing partner of the law firm Herbert Smith Freehills in Italy, Laura Orlando is one of Italy’s leading life sciences specialists, with a focus on IP and regulatory matters.  Together with Sara Balice, one of the firm’s senior associates they examine the Court of Justice of the European Union’s (CJEU) ruling on the Reimbursement of off-label medicinal products.   It is the responsibility of EU Member States to control off-label use of medicinal products.   Under EU Legislation (Directive 2001/83/EC, the “Directive”),…