Tagged with Legal Handbook

Pharma Legal Handbook All legal aspects surrounding preclinical and clinical trial requirements in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted…

Pharma Legal Handbook An insight into regulatory, pricing and reimbursement overview in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over…

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 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 All legal aspects surrounding orphan drugs and rare diseases in Canadian Pharma. 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. What is the definition of Rare Diseases in your country? In…

Pharma Legal Handbook The legal framework for cannabinoid drugs, medical cannabis and opioids in Canada. 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.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. Cannabinoids can…

Pharma Legal Handbook An insight into upcoming regulatory reforms affecting Canadian pharma. 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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There are three significant…

Pharma Legal Handbook The low-down on the situation regarding patents and trademarks in Canadian pharma. 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. What are the basic requirements to obtain patent and trademark protection?…

Pharma Legal Handbook All about product liability in Canadian pharma. 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. What types of liability are recognized in your jurisdiction? In general terms, product liability arises from claims…

Pharma Legal Handbook An intro to the legal situation for traditional products and OTC medicines in Canada. 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. What are the regulatory requirements for traditional, herbal, complementary, or alternative…

Pharma Legal Handbook The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising in Canadian pharma. 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. What is the authorization process for…

Pharma Legal Handbook Preclinical and clinical trial requirements for pharma in Canada – a comprehensive legal overview. 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 clinical trials required to be conducted locally…