Tag archives: Health Canada

Health Canada releases Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

By Jillian Hyslop (CA) and Sara Zborovski (CA) on June 21, 2017 Posted in International

Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling Regulations.” As of June 13, 2017, the Plain … Continue reading

Court upholds Health Canada decision requiring additional information ‎on certain Apotex drugs manufactured in India

By Ian Trimble (CA), Kristin Wall (CA) and Sara Zborovski (CA) on April 6, 2017 Posted in FDA & Food Safety, International

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s decision to require additional information from Apotex as part of its submissions for certain drugs manufactured in India by Apotex affiliates. Read the full update here.… Continue reading

Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing

By Jillian Hyslop (CA) and Sara Zborovski (CA) on February 1, 2017 Posted in FDA & Food Safety, International

On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing. The consultation period is open until April 18, 2017. Read the full update in Norton Rose Fulbright’s Pharma in brief – Canada.… Continue reading

Health Canada releases revised guidance document on approval pathway for biosimilars (formerly “subsequent-entry biologics”)

By Christopher Guerreiro (CA) and Marie-Hélène Rochon (CA) on January 11, 2017 Posted in Regulatory

Summary Health Canada has revised its guidance document on the approval pathway for biosimilar biologic drugs (biosimilars). The headline change is in the name: Health Canada has retired the “subsequent-entry biologics” moniker. The revised Biosimilars Guidance Document also contains overhauled guidelines for selecting reference biologics, satisfying the scientific review requirements of the Biologics and Genetic … Continue reading

Sugar, Salt and Fat : the Usual Suspects Targeted by Health Canada’s Proposed Mandatory Front-Of-Package Labelling System

By Sara Zborovski (CA) on December 14, 2016 Posted in FDA & Food Safety

Health Canada is contemplating mandatory front-of-package (FOP) labelling for prepackaged foods high in “nutrients of public concern”, namely sugars, sodium and saturated fat. This is one of the key initiatives put forward by Health Canada as part of its Health Eating Strategy, announced on October 24, 2016. A public consultation was launched on November 14, … Continue reading