As recently published in the Canada Gazette, Health Canada published the final amendments to the Natural Health Products and the Food and Drugs Regulations, also known as the Self-Care Framework. These amendments are part of the Forward Regulatory Plan 2022-2024 and will ensure that Natural Health Products are labelled in a manner comparable to similar self-care products such as non-prescription drugs. Moreover, the amendments proposed will introduce a risk-based approach to regulatory oversight of all self-care products.
These proposals will be completed in phases, with Phase I involving the improvement of labelling of Natural Health Products, which has been completed as of 5th July, 2022. This amendment will include:
- Product fact tables
- Formatting requirements
- Improving allergen labelling
- Tamper evidence alignment under CUSMA
- Modernized contact information
The following Phase II will introduce expedited pathways for lower-risk non-prescription drug products, with Phase III expanding the efficiencies and modernization pertaining to non-prescription drugs to NHPs.
The period in which new products will phase in the amended regulations is 3 years, with an additional 3 years for existing products. Additional details such as the associated guidance documents accompanying the regulation changes will follow via the NNHPD.
Click here to view the original article published by the Canada Gazette.
If you have any questions on the updates or would like assistance with NHP compliance, please contact us.