Tag archives: Food and drug regulations

Health Canada releases updated Certificate of Supplementary Protection guidance

Photo of Sarah PenningtonPhoto of Paul JorgensenPhoto of Kristin WallBy Sarah Pennington, Paul Jorgensen and Kristin Wall on Posted in Pharmaceuticals and life sciences
On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance).  The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Photo of Sarah PenningtonPhoto of Kristin WallBy Sarah Pennington and Kristin Wall on Posted in Life sciences and healthcare
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. … Continue reading

Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways

Photo of John GreissPhoto of Kristin WallBy John Greiss and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
As we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to … Continue reading

Health Canada amends regulations to permit distribution of OTC and NHP samples to general public

Photo of John GreissPhoto of Randy SuttonBy John Greiss and Randy Sutton on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences, Uncategorized
Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC) drugs) and natural health products (NHPs) to a larger scope of healthcare professionals as well as the general public. Previously, the distribution of … Continue reading

Proposed regulations published on additional elements of Vanessa’s Law

Photo of Olga FarmanBy Olga Farman on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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 draft regulations also set out additional reporting requirements for manufacturers based on the actions of … Continue reading

Health Canada proposes regulations allowing importation of drugs not yet available in Canada for an urgent public health need

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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 urgent public health need provided they have been approved in the United States, the European … Continue reading
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