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Health Canada

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

Photo of Jillian Hyslop (CA)Photo of Sara Zborovski (CA)
By Jillian Hyslop (CA) & Sara Zborovski (CA) on June 21, 2017

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…

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

Photo of Ian Trimble (CA)Photo of Kristin WallPhoto of Sara Zborovski (CA)
By Ian Trimble (CA), Kristin Wall & Sara Zborovski (CA) on April 6, 2017

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

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Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing

Photo of Jillian Hyslop (CA)Photo of Sara Zborovski (CA)
By Jillian Hyslop (CA) & Sara Zborovski (CA) on February 1, 2017

On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing.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 …

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

Photo of Christopher A. GuerreiroPhoto of Marie-Hélène Rochon (CA)
By Christopher A. Guerreiro & Marie-Hélène Rochon (CA) on January 11, 2017

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…

Symbols-for-FOP-labelling

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

Photo of Sara Zborovski (CA)
By Sara Zborovski (CA) on December 14, 2016

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…

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