Health Canada has released an updated version of Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations. According to Health Canada, the guidance document has been updated to reflect judicial consideration of “innovative drug” and current administrative
On May 16, 2017, Health Canada published a consulting paper titled “Protecting Canadians from Excessive Drug Prices.” The paper describes five proposed amendments to the Patented Medicines Regulations that are meant to help better assess whether the price of a
On April 28 the Federal Court issued a Notice to the Parties and the Profession containing new guidelines for the trial management of actions. Among other things, they set new deadlines for various pre-trial steps and for the filing of
It’s official – the Canadian government has approved the changes to Canada’s pharmaceutical patent regime. On May 16, 2017, Bill C-30 (the act intended to implement CETA into Canadian law) received royal assent, the final stage of the legislative process.
On April 22, 2017, the Government of Canada published draft regulations Amending the Food and Drug Regulations (Vanessa’s Law) that provide details regarding the minister of health’s powers to require tests, assessments and studies of a drug post-market authorization. The
Treaty/Act: CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States and to provide for certain other measures)
With Canada moving closer towards implementing the Comprehensive
Case: Apotex Inc v Eli Lilly Canada Inc, et al (SCC Docket 37368)
Drug: CIALIS® (tadalafil)
Nature of case: Application for leave to appeal decision upholding prohibition order granted pursuant to section 6 of the Patented Medicines (Notice of
Health Canada has proposed regulations that will amend the Food and Drug Regulations to allow for importation of drugs that have not yet received regulatory approval from Health Canada. The new regulations will provide access to drugs that address an