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Court affirms Health Canada’s broad discretion in review of drug submissions
- Torys LLP
- -
- Canada
- -
- April 13 2010
In a recent decision of the Federal Court in Hospira Healthcare Corporation v. Canada (Attorney General) the Court affirmed that Health Canada has broad discretion in interpreting the Food and Drug Regulations to determine the content of an application for the marketing approval of a drug
Ontario companies doing business with hospitals may become subject to access-to-information requests
- Torys LLP
- -
- Canada
- -
- April 6 2011
Pharmaceutical and medical device companies doing business with Ontario organizations that accept public funding, including hospitals, may be affected by recent legislative amendments aimed at increasing transparency and accountability of these entities
Proposed amendment would exempt some generic submissions from Canada’s PM(NOC) regulations
- Torys LLP
- -
- Canada
- -
- October 4 2011
Health Canada has released a proposed amendment to its guidance document Patented Medicines (Notice of Compliance) Regulations
Canada to change the regulation of “food-like" natural health products
- Torys LLP
- -
- Canada
- -
- April 24 2012
On April 17, 2012, Health Canada announced that it will classify and transition all "food-like" natural health products (NHPs) to the regulatory framework that governs the sale of food products in Canada
Health Canada’s guidance document on PM(NOC) Regulations now finalized
- Torys LLP
- -
- Canada
- -
- April 4 2012
Health Canada has published an update to its guidance document on the application of the Patented Medicines (Notice of Compliance) Regulations
Canada’s PAAB releases updated Code of Advertising Acceptance
- Torys LLP
- -
- Canada
- -
- December 7 2012
The Pharmaceutical Advertising Advisory Board (PAAB) has released a revised version of its Code of Advertising Acceptance
Health Canada announces intent to develop a framework for orphan drug approval
- Torys LLP
- -
- Canada, USA
- -
- October 5 2012
On October 3, 2012, Health Canada issued a press release announcing that it will develop a framework for the marketing approval of drugs to treat rare life-threatening, seriously debilitating or serious chronic rare diseases that are commonly referred to as "orphan drugs."
Data protection in Canada: Court of Appeal confirms narrow approach
- Torys LLP
- -
- Canada
- -
- January 30 2013
On January 18, 2013, the Federal Court of Appeal (FCA) released its decision in Takeda Canada Inc. v. The Minister of Health and Attorney General of
Canada amends regulations on adverse drug reaction reporting
- Torys LLP
- -
- Canada
- -
- March 11 2011
Amended regulations regarding the reporting of adverse drug reactions came into force on February 10, 2011
Ontario government seeks appeal of pharmacies' successful challenge on private label restrictions
- Torys LLP
- -
- Canada
- -
- February 24 2011
The regulation of private label drug products remains in flux with the recent decision of the Ontario Superior Court of Justice (Divisional Court) and potential appeal of that decision
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- Author - Teresa A. Reguly
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