Implementation and Updates to the USMCA

by | Jul 8, 2020 | Canadian Regulatory, Natural Health Products, OTC Drugs, U.S. Regulatory

As of July 1st, the United-States-Mexico-Canada Agreement or USMCA has officially begun being implemented. As such, it would be best to discuss the details and what this agreement means for stakeholders.  

The agreement was made to reinforce the economic ties between the United States, Mexico, and Canada while replacing the North American Trade Agreement. The agreement promoted efficient and transparent customs procedures that reduce costs for both importers and exporters. The agreement includes regulations with elements of environmental protection and a gender bias analysis, which ensures equal opportunity for all gender, race, and for small and medium enterprises.  

We have previously reported on which products will be impacted by USMCA, however this list has since been amended. Previously, the impacted Natural Health Products and Non-Prescription Drugs were only those on Health Canada monographs. This has since been changed to include all products listed within the appendix of the USMCA, such as antiseptic skin cleansers, acne therapy products, and antiperspirants. This requires changes to List A: List of Certain Natural Health Products for Distribution as Samples, List D: List of Certain Non-prescription Drugs for Distribution as Samples, List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019, and of the Food and Drug Regulations Do Not Apply, to include all currently authorized products in the USMCA.  

This revision could not be made officially prior to the July 1st implementation date. For now, the products listed in the appendix of the USMCA will be exempt from sampling prohibitions and the enforcement actions will be de-prioritized. After a comment period, a Notice of Modification as well as the revised lists will be published on Health Canada’s website.  

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.