July 14, 2020 – Health Canada announced that amendments to the Food and Drug Regulations will come into effect July 1, 2020 as part of the Canada – United States – Mexico Agreement (CUSMA).
The amendments reflect many of the flexibilities including an elimination of duplicative testing requirements and allowance of direct shipment of certain non-prescription drugs. As part of the coming into force, the regulatory changes also include allowances for the distribution of certain non-prescription drugs as samples.
The regulatory amendments provide flexibility for importers of lower-risk products and Health Canada is actively working to increase the number of products to which the regulatory amendments apply. While the work to expand the scope of the regulations is ongoing, Health Canada will be expanding the interim measures to ensure that a wider range of products can avail of these flexibilities including all those identified in the Annex below.
The amendments to eliminate duplicative testing requirements and allow direct shipping is expanded by this policy to apply to all products listed in Annex A sourced from recognized countries or regions. This interim measure will be in place until such time that the official list referenced in the regulatory amendments has been formally updated.
Health Canada will also be expanding the list of drugs which may be distributed as samples. While we work towards implementing the expanded list, products in Annex A will be exempt from sampling prohibitions in light of the impending changes and enforcement actions will be de-prioritized. This interim measure will be in place until such time that the list referenced in the regulatory amendments has been formally updated.
What does eliminating duplicative testing requirements mean?
Importers of the products listed in Annex A from recognized countries or regions are not required to perform:
- Identity testing after receipt in Canada as part of the release process, and
- Confirmatory testing
Importers of impacted product must ensure that products are manufactured appropriately and that they meet finished product specifications. The regulatory amendments allow such determinations to be made via Batch Certificate or Certificate of Manufacture/ Analysis review.
What is Direct Shipping?
Direct shipping means that importers will be able to ship product from a foreign site directly to a Canadian customer (e.g. a retailer/wholesaler). Direct shipping will be allowed under the following conditions:
- The importer releases the drug before it is shipped by reviewing all applicable documentation and testing results;
- The importer has measures in place to ensure all requirements of the regulations are met. This means identifying roles and responsibilities and having appropriate agreements between all parties including the foreign manufacturer, importer and person receiving the product (e.g. the retailer or wholesaler).
Will there be guidance related to the elimination of duplicative testing requirements and allowance of direct shipping?
The following guidance documents will be updated over the next few weeks in response to the regulatory amendments:
- Good manufacturing practices guide for drug products (GUI-0001)
- Annex 7 to the Good manufacturing practices guide for drug products- Selected non-prescription drugs (GUI-0066).
Note: GUI-0066 will apply to all products listed in Annex A and the title of the guidance document has been changed to reflect its expanded scope.
Both guidance documents will include additional updates that are considered minor in nature.
HC will host a free information session on July 22, 2020 for stakeholders to provide additional information on the amended Food and Drug Regulations.
The intent of the webinar is to highlight important information related to the amendments to the Food and Drug Regulations and to provide an open forum to ask questions.
To attend the information session you must register ahead of time, as there are limited spaces (approx. 200 participants).
To register for the ENGLISH session on July 22 go to Register.
To register for the FRENCH session on July 22 go to Register.
Once you are approved by the host, you will receive a confirmation email with instructions for joining the session.
You may email email@example.com? for further clarification with respect to the interim measures and the products to which they apply.