As a followup to the recent amendments to
Canada's Food & and Drugs Act that came
into force on Nov. 6, 2014, Protecting Canadians from
Unsafe Drugs Act or "Vanessa's Law," Health
Canada has now posted interpretive guidelines for comment. The
deadline for comments is June 8, 2015.
The recent legislative amendments gave Health Canada new powers
to address health and safety concerns regarding "therapeutic
products" (which includes both drugs and medical devices but
not natural health products). These powers include, but are not
necessarily limited to:
issuing orders to require information where there may be
concerns relating to serious risk of injury;
the ability to disclose confidential business information
without notice where there are concerns of serious risk or injury
or for the protection or promotion of human health or public
orders to modify product labels and packaging; and
Of most interest to many in the industry is how the powers of
collection and disclosure of information, especially confidential
business information will be handled and the effect of same on
co-existing access to information legislation. The guidelines
provide some insight to Health Canada's approach to how they
will exercise their new powers, including thresholds, triggers and
Although the guidelines are not expansive, they do state that
before exercising its power to issue orders requesting information,
Health Canada is proposing to first notify the product
authorization holder and provide an opportunity to respond.
With respect to disclosure of confidential business information,
the guidelines indicate that supporting regulations will be
developed with input from stakeholders and in compliance with
Canada's international treaty obligations under TRIPS and
The draft guidelines are already in use by Health Canada in the
interim but are not finalized pending receipt of comments.
The prospect of an internal investigation raises many thorny issues. This presentation will canvass some of the potential triggering events, and discuss how to structure an investigation, retain forensic assistance and manage the inevitable ethical issues that will arise.
From the boardroom to the shop floor, effective organizations recognize the value of having a diverse workplace. This presentation will explore effective strategies to promote diversity, defeat bias and encourage a broader community outlook.
Staying local but going global presents its challenges. Gowling WLG lawyers offer an international roundtable on doing business in the U.K., France, Germany, China and Russia. This three-hour session will videoconference in lawyers from around the world to discuss business and intellectual property hurdles.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
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