Home/Pharmaceuticals/What you need to know about Health Canada’s Regulatory Amendments for Non-Prescription Drug Products (GUI-0001)

What you need to know about Health Canada’s Regulatory Amendments for Non-Prescription Drug Products (GUI-0001)

 Health Canada Guidelines for Software As A Medical Device

Health Canada’s regulatory amendment to the Food and Drugs Regulations Guidance Document GUI-0001 came into effect on July 1st as part of the Canada-United States-Mexico Agreement (CUSMA) and replaces the previous 2018 edition.

The new amendments emphasize finished product testing of non-prescription drug products and directly affects importers and distributors and requires reviewing and updating of certain documents and agreements.

Non-Prescription Drug Products

The new expectations from the regulatory amendments are an effort to streamline and provide flexibility to the importation and distribution of the following lower-risk non-prescription drug products:

  • Personal care use antiseptic skin cleansers
  • Sunscreens
  • Anti-dandruff products
  • Diaper rash products
  • Medicated skin care products
  • Acne therapy products
  • Throat lozenges
  • Athlete’s foot products

Amendment Highlights

The amendments allow for:

  • the elimination of duplicative finished product testing and identity testing as part of the release process provided the products meet all the fabrication, packaging, labeling, claims, and testing requirements outlined in section C.02.019 of the Food and Drug Regulations.
  • the elimination of confirmatory testing (periodic confirmatory tests are required for non-MRA countries for products that are not on the list)
  • the direct shipment by importers to retailers, wholesalers, and individuals for tested products from a recognized country or region.

The requirement for oversight does not change. Importers and distributors will continue to be responsible for full product release activities by ensuring products comply with finished product specifications.  This will take place through review of the Batch Certificate. If a batch certificate is not available, a review of a Certificate of Analysis (CofA) or Certificate of Manufacturing (CofM) provided all they contain all the information that would be found in the batch certificate.  Importers are also be responsible for evaluating the storage and transportation conditions for each shipment. Importers and distributors are responsible for having the appropriate quality agreements, identifying roles and responsibilities, between all the parties involved.

It is important to note that the Expanded Sunscreen Pilot program is cancelled since the new amendments incorporate the flexibilities.

How will this affect Importer Documentation?

The new amendments will require reviewing and updating of SOPs and Quality Agreements. This includes:

  • Review and modification of current Quality Agreements
  • Review and modification for Self-Inspections SOPs as they relate to analytical laboratories
  • Review and modification for finished drug product Release SOPs
  • Canadian importers that participate in the Expanded Sunscreen Pilot are required to follow the amended Regulations and update all their documents to reflect the amendments
  • Maintenance of SOPs for APIs, Manufacturers
  • Review and updating of Importer Agreements with foreign sites

Keep in mind that these regulatory amendments are an ongoing initiative and Health Canada will continue to expand these measures to include a wider range of products, changes to countries and product lists.

How we help

Our knowledge, experience and insight make us the first choice for clients when it comes to regulatory licensing, compliance, and quality matters. We can your support or conduct documentation reviews to assess whether your products fall under the List of Non-Prescription Drugs Not Subject to Certain Testing Requirements; update your Finished Product Testing and Identity Testing processes and procedures; and, whether direct shipment of applicable products to customers would benefit your business.

Contact Us