Tagged with Legal Handbook

Pharma Legal Handbook Want to know more about the localization in Canada? Read on! Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. Are there any rules or regulations requiring and/or encouraging localization in your…

Pharma Legal Handbook Biosimilars and biologics in Canada: A legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar is…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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,…

Pharma Legal Handbook 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…

Pharma Legal Handbook  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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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?…

Pharma Legal Handbook 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…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic medicines (i.e., without the submission of pre-clinical or…

Pharma Legal Handbook The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here.   1. Are biosimilar medicines considered the same as generic medicines in your country? A…