Tagged with NDB

Pharma Legal Handbook 16. 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 approval, a company must submit an NDS application containing information…

Pharma Legal Handbook 22. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are mentioned in Chapter 1, Question 3: What are the steps…

Pharma Legal Handbook 44. 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 Health Products Regulations, which provide requirements concerning…

Pharma Legal Handbook 53. 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…

Pharma Legal Handbook 58. 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 by the agency. All forms and guidelines…

Pharma Legal Handbook 66. Are there proposals for reform or significant change to the healthcare system? There are three significant changes which are currently evolving that will impact healthcare in Canada in the future.   National Pharmacare As of October 10, 2024, Canada adopted the Pharmacare Act which seeks to provide a national…

Pharma Legal Handbook CANNABINOID DRUGS 68.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 means that Cannabinoid Drugs must be submitted…

Pharma Legal Handbook 103. 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 based and appear at birth or in…

Pharma Legal Handbook 114. 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? As of November, 2021, drugs intended for the Canadian market that could cause or exacerbate a shortage are prohibited from being distributed outside of Canada.…

Pharma Legal Handbook 123. 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.[1] A biosimilar is a subsequent entry version…

Denmark When it comes to Denmark’s flourishing local biotech scene, the country is again clearly punching far above its weight. The EU member state has already managed to muster world-class expertise in areas like peptide chemistry and metabolic disorders, anchored by the success stories of homegrown entities that made it big…

Denmark Making Life Sciences Strategic The super-sized contribution of the life sciences sector to Denmark’s national economy can hardly be overstated. With over 100,000 professionals currently engaged in biotech and pharmaceuticals across the country, Denmark already ranks as one of the European Union member states with the largest proportion of the…