Regulatory Roundup: Spring 2020

Regulatory Roundup: Spring 2020

2020 not only represents the start of a new decade, but it is definitely proving to be a year to be remembered!  The Source Team has conducted a regulatory roundup to help keep our clients connected with all the latest developments in the Canadian health products sector.

Read on to learn what regulatory changes the Government of Canada is implementing to support the COVID-19 pandemic, and more about new developments relating to the legalization of cannabis and cannabis edibles.

Coronavirus (COVID-19)

The Government of Canada continues to monitor and address the numerous challenges associated with the novel coronavirus (COVID-19) pandemic impacting all Canadians. Source has been keeping our finger on the pulse of regulatory-related COVID-19 developments, and our Regulatory Team has put together a summary of key developments for our clients.

Expedited Access to Disinfectants, Hand Sanitizers and Personal Protective Equipment

On March 18, Health Canada announced that they would be expediting access to products such as hand sanitizers, disinfectants and personal protective equipment [PPE] to help minimize the spread of COVID-19.
Click here for the Health Canada press release.

Due to an unprecedented demand for these products, Health Canada’s Interim Measure will allow access to products which are not fully compliant with Canadian regulations.  This expedited review will include products which are typically regulated as Non-Prescription Drugs (disinfectants, some hand sanitizers); Natural Health Products (some hand sanitizers) and Class I Medical Devices (gowns and masks), and will allow the sale of:

  • Products which have gained Market Approval for respective Health Canada requirements, but are not yet fully compliant (i.e. lack labelling compliance); and
  • Products not yet authorized for sale in Canada, but which have gained approval from reputable foreign regulatory authorities.

If you are looking to import new health products to help prevent the spread of COVID-19, Health Canada will also expedite the import licensing process (i.e. to obtain a new Drug Establishment License or Site License).  If you need help with import licensing or product labelling of disinfectants or hand sanitizers, reach out to our Regulatory Affairs Team today.

Expedited COVID-19 Medical Device Regulatory Review

On April 3, Health Canada released an Interim Order for medical device applications to be used in relation to COVID-19. Click here for Health Canada press release.

This Interim Order signified the creation of expedited regulatory pathways for medical devices that are a part of a system, test kit, medical device group or family related to the novel coronavirus, specifically:

  • New COVID-19 medical devices which are not yet licensed in Canada or other jurisdictions;
  • Existing medical devices previously licensed under the Medical Device Regulations, for additional use relating to COVID-19; or
  • Existing COVID-19 devices without Canadian regulatory approval, but who hold an international regulatory approval from a trusted foreign regulatory authority.

If you have a medical device relating to the COVID-19 pandemic, and you are interested in learning more about the Interim Order for expedited licensing, connect with the Source Team today!

Safe Food for Canadians Regulations Compliance and Enforcement

  • On April 7, the Canadian Food Inspection Agency (CFIA) announced that they would no longer prioritize compliance and enforcement efforts related to the Safe Food for Canadians Regulations (SFCR), in light of the COVID-19 pandemic. Click here for the full press release.
  • The CFIA is still encouraging companies to initiate or continue with the food import licensing process; however, Canadian companies importing foods will not be penalized currently for not having an import license.
  • Source’s Food Safety Team has a wealth of experience in establishment and site licensing, and would be pleased to discuss your import licensing requirements under the SFCR. Email us today to set up a consultation!

Legalization of Cannabis

The Canadian cannabis market continues to grow and expand, following the legalization of recreational cannabis in 2018, and of cannabis edibles in late 2019. In early 2020, Canadian consumers were able to purchase cannabis edibles from licensed retailers.

Data from the Canadian Food Safety Institute reveals that the top 4 categories of cannabis edibles are:

  • Gummies
  • Cookies
  • Brownies
  • Chocolates

To learn more about cannabis regulations in Canada, check out our recent blog post, “Catch up on the Canadian Cannabis Industry”.

Does your company have interest in developing edible cannabis products?  If you do, our regulatory experts would be happy to help!  Reach out and connect with Source today!

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