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Related Articles

Canada’s COVID-19 Vaccination Strategy

04/12/2020

Fasken

Canada

Fasken Canada’s Dara Jospe and Denis Douville examine Canada’s COVID-19 vaccine strategy, from the steps the country has taken to expedite the approval process to its funding of R&D projects and the preparations needed for ensuring the necessary supply and distribution infrastructure is in place. Vaccination is a historically successful strategy to prevent the spread of infectious diseases. The immunization of a large enough proportion of a population will reduce the percentage of vulnerable hosts to a level below…

Biosimilars and Biologics

05/09/2019

Fasken

Canada

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 USD 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar is not a generic biologic product since it is not identical to its reference product; its authorization does not constitute evidence of pharmaceutical equivalence, bioequivalence or clinical equivalence. A biosimilar is a…

Localization

05/09/2019

Fasken

Canada

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 USD 99. 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? No, there are no rules or regulations requiring and/or encouraging localization in Canada. Nonetheless, all drugs imported into Canada…

Orphan Drugs and Rare Diseases: Canada

05/09/2019

Fasken

Canada

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 USD 99. 1. What is the definition of Rare Diseases in your country? In Canada, “Rare Diseases” are defined as “life-threatening, debilitating or serious, and chronic conditions affecting a small number of patients, many of which predominantly affect children, as these diseases are often genetically…

NEW Update to Health Canada’s Policy

18/06/2019

Fasken

Canada

It is not a secret anymore, many in the industry now know that Health Canada is working on a new version of the policy entitled: The Distinction Between Advertising and Other Activities, dated more than 20 years ago. Earlier this week, Health Canada provided some insights about the reformed policy and offered target timelines for publication and entry into force. The new Distinction Policy should be published in a draft format before the end of this month, in late…

The Future of Cannabis and Cosmetics in Canada

24/04/2019

Fasken

Canada

In the light of several recent regulatory updates to Canada’s cannabis laws, lawyer Jean-Raphaël Champagne examines the potential for cannabis to be legalised for use in cosmetic products in Canada. One thing that Bill C-51 did not change was the relationship between cannabis substances and cosmetic products in Canada Cannabis legislation in Canada has come with its fair share of legislative amendments. Bill C-51 not only enacted the Cannabis Act; it also introduced a number of amendments and transitional…

Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

28/01/2019

Fasken

Canada

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 USD 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. Cannabinoids can be the active ingredient of a drug product in Canada, provided that such product meets applicable safety, effectiveness and quality requirements under the Food and Drugs Act and its regulations. This…

Regulatory Reform

28/01/2019

Fasken

Canada

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 changes which may affect or impact healthcare in Canada. NATIONAL PHARMACARE Currently, Canada is the only member country of the Organization for Economic Co-operation and Development with universal public health…

Patents & Trademarks

28/01/2019

Fasken

Canada

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 USD 99. 1. What are the basic requirements to obtain patent and trademark protection? In order to obtain patent or trademark protection, one must submit an application to the Canadian Intellectual Property Office (“CIPO”) and comply with the formalities of the application process set out…

Product Liability

28/01/2019

Fasken

Canada

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 USD 99. 1. What types of liability are recognized in your jurisdiction? In general terms, product liability arises from claims in contract or civil wrongs under the common law or civil code, depending on the province. Plaintiffs can hold manufacturers concurrently liable in either contract or civil wrongs. Contractual Liability Plaintiffs…

Traditional Medicines and OTC Products

28/01/2019

Fasken

Canada

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 USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the Natural…

Marketing, Manufacturing, Packaging & Labeling, Advertising

28/01/2019

Fasken

Canada

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 USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal…

Preclinical and Clinical Trial Requirements

28/01/2019

Fasken

Canada

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 USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain marketing…

Regulatory, Pricing and Reimbursement

28/01/2019

Fasken

Canada

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs 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 USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s…

Cannabinoid Drugs and Medicinal Cannabis

12/10/2018

Fasken

South Africa

Structured legal guide to cannabinoid drugs, medicinal cannabis and opioid drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabis use is illegal in most countries and until recently this included South Africa. In terms of the Drugs and Drug Trafficking Act (“the Drugs Act”) it is…

Regulatory Reforms

12/10/2018

Fasken

South Africa

Regulatory reforms in South African Pharma – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? NATIONAL HEALTH INSURANCE BILL AND MEDICAL SCHEMES AMENDMENT BILL On 21 June 2018 the Minister of Health Published the Medical Schemes Amendment Bill and the National Health Insurance…

Patents & Trademarks

12/10/2018

Fasken

South Africa

The ins and outs of patents and trademarks in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents and Trademarks form part of Intellectual property in terms of South African law, where Intellectual Property is defined as: “a generic term used to refer collectively to…

Product Liability

12/10/2018

Fasken

South Africa

The key facts about product liability in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? In terms of South African common law legal liability may arise from a breach of contract or from delict. Liability in delict may arise irrespective of the existence of a contract…

Traditional Medicines & OTC Products

12/10/2018

Fasken

South Africa

Traditional medicines & OTC products in South Africa – a legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the In terms of the…

Marketing, Manufacturing, Packaging & Labelling, Advertising

12/10/2018

Fasken

South Africa

All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? MARKETING OF MEDICINES AND MEDICAL DEVICES OR IVDS: Marketing of medicines are regulated by Section…

Preclinical & Clinical Trial Requirements

12/10/2018

Fasken

South Africa

All about preclinical & clinical trial requirements in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Clinical Trials do not have to be conducted locally in order for the Regulator to register the product and market approval to…

Regulatory, Pricing and Reimbursement

12/10/2018

Fasken

South Africa

An insight into regulatory, pricing and reimbursement in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The South African Health Products Regulatory Authority (SAHPRA), previously known as the Medicine and Control Council (MCC). 2. What is the regulatory…