CA Secures Last Minute Changes to Ensure CUSMA Compliance
In a late afternoon teleconference with stakeholders, Health Canada today confirmed that they will be issuing a DEL Bulletin outlining further changes to provide for the full implementation of the benefits of CUSMA for our industry effective next Wednesday, July 1st. These were secured through a concerted effort by the CA team over the past two weeks after the release of Health Canada’s initial plans did not incorporate the full scope of the CUSMA provisions.
To summarize, these changes allow for the full range of products included in the scope of Appendix 1 of CUSMA’s Cosmetics Annex to benefit from the elimination of “quarantine and confirmatory re-testing”, as well as allow these products to be included in the new rules for sampling. The original Health Canada implementation plans essentially applied to only monographed products and could have been expected to result in a trade complaint under CUSMA.
More specifically, the revisions will:
- Re-configure the List for Non-prescription Drugs: With Respect to the Distribution of Samples; and for Non-prescription Drugs for Which the Testing Requirements Set out in Subsections c.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply such that it includes all products set out in the CUSMA scope rather than just monographed products.
- Re-configure List A: Certain Non-prescription Drugs for Distribution as Samples to also allow for the inclusion of the full CUSMA scope of products and not just monographed products.
- Re-configure List A: Certain Natural Health Products for Distribution as Samples to also allow for the full scope of CUSMA defined products. As this revision requires a regulatory amendment which cannot be made before the July 1st implementation date, these products will be exempt from sampling prohibitions and enforcement actions will be de-prioritized. We understand that this interim measure will be in place until such time that the list referenced in the regulatory amendments has been formally updated.
Any company or their legal representative who may have questions, or require clarity, will be invited to contact a Health Canada representative such that no company is denied the benefit of these new CUSMA provisions as of July 1st, 2020. The CA team will also be available to answer any of your questions.
The full benefits of CUSMA’s Cosmetics Products Annex were secured through the coordinated efforts of Cosmetics Alliance Canada, the U.S. Personal Care Products Council (PCPC) and the Mexican Cosmetics Industry Association (CANIPEC) during the two-year long NAFTA negotiations.
It is estimated that the savings from the elimination of the “quarantine and re-testing” provisions on these “cosmetic-like D.I.N. products” is some $100K per year per SKU.
CA would like to thank Health Canada Deputy Minister Dr. Stephen Lucas and his teams at the Natural and Non-prescription Drug Directorate (NNHPD) and the Regional Operations and Enforcement Branch (ROEB) for their efforts and engagement with our CA team over the past two weeks. Through these combined efforts we were able to resolve this issue and ensure that there would not be a trade complaint under CUSMA after July 1st. We would also like to also thank our colleagues at the U.S. PCPC who worked closely with us to manage the issue with U.S. trade officials.
CA will provide more details once the formal materials are posted by Health Canada.
For any questions or comments, please contact your CA Team.
