23/01/2020
Regulatory, pricing and reimbursement overview in Italy – a legal guide. 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 authorities with jurisdiction over drugs, biological, and medical devices in your country? The Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) is the national authority vested with jurisdiction over medicinal products (including biologics). The Ministry of Health (Ministero della Salute) is responsible for the regulation and monitoring of medical devices and has jurisdiction in relation to certain aspects pertaining to the regulation of non-prescription medicines (e.g., promotion). 2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biological, and medical devices? a. Authorization Italian legislative decree 219/2006 on medicinal products for human use (“Italian Medicines Code”), implementing Directive…
The key facts about regulatory reforms 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. Are there proposals for reform or significant change to the healthcare system? The most…
All legal aspects surrounding patents & trademarks in Italian Pharma. 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 basic requirements to obtain patent and trademark protection? Italian…
The low-down on the situation regarding product liability 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 types of liability are recognized in your jurisdiction? The Italian system…
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…
All about marketing, manufacturing, packaging & labeling, advertising 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 is the authorization process for the marketing of new drugs, biologics,…
Key legal info on preclinical and clinical trial requirements 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. Are clinical trials required to be conducted locally as a condition…
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