Here’s what’s new from Health Canada…
Guide on Health Canada Implementation of Changes to the Food and Drugs Act
Health Canada has issued a Guide to New Authorities, setting out the guiding principles that will govern decision making with respect to the new powers given it pursuant to the recent changes to the Food and Drugs Act (see our previous newsletter for particulars).
Among other things, this Guide discusses how Health Canada will determine whether a therapeutic product presents a serious risk of injury to human health and describes when such a risk will be considered “imminent” for recall ordering purposes.
Although the Guide is already in use, Health Canada is seeking stakeholder comments prior to its finalization. We encourage all stakeholders to read the consultation document carefully and if you are interested in making comments, note that the deadline for comments is June 8, 2015.
OECD Global Tracking/Traceability Information Exercise
In March, Health Canada circulated the draft OECD proposal to enhance consumer product tracking and traceability tools for consumers, regulators and stakeholders. The OECD is seeking public comment on the feasibility of specific practices aimed at improving tracking information on consumer products.
The consultation paper can be found here. Comments are due by May 30, 2015.
Regulation of Reprocessors of Single Use Devices
Earlier this year, Health Canada announced changes to its oversight over commercially reprocessed single use medical devices.
Under the federal regulatory framework, companies that reprocess and distribute medical devices originally authorized and labelled for single use to Canadian healthcare facilities will be held to the same requirements as manufacturers of new devices. It is anticipated that these requirements will be implemented over an 18 month transition period to allow affected parties to bring themselves into compliance.