Health Canada Requests Comments on the Regulation of Self-Care Products

14/09/16

Event Title

08h00 - 16h30

Event Location

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Health Canada has released a Consultation on the Regulation of Self-Care Products which is intended to discuss and receive comments on a new approach to regulating self-care products including Cosmetic, Natural Health Products (NHP), and Non-Prescription Drug products.

In the Consultation they discuss how Cosmetic, NHP and Non-Prescription Drug products may be used in the same manner or have similar claims, but are regulated very differently. To help ensure a consistent evaluation between products, they are proposing a risk-based approach, divided into lower risk, moderate risk, and higher risk self-care products. Lower risk products are defined as those with a history of safe use and no diagnostic, treatment, prevention, cure, or mitigation claims. Moderate risk products would be approved under a monograph system and companies would need to meet safety and efficacy standards. Higher risk products would include new ingredients, new claims, or new uses for products and would require scientific substantiation and safety evaluations by Health Canada. For Lower risk products, there would be no review or licensing, moderate risk products would require some review, and higher risk products would require full review by Health Canada.

Health Canada will also require approval of “health claims” defined under the proposal as, “claims that pertain to diagnosis, treatment, prevention, cure, or mitigation of a disease or serious health condition.” Any health claims would require scientific evidence to support the claim. This means that a homeopathic product and a non-prescription drug product that both make the claim “relieves cough and cold” would need the same amount of substantiation. Claims that speak to the function of the product would not be considered health claims. The Consultation document provides additional examples of what would constitute a health claim.

The Consultation is available until October 24, 2016.

Click to view the Consultation on the Regulation of Self-Care Products:
http://healthycanadians.gc.ca/health-system-systeme-sante/consultations/selfcare-autosoins/index- eng.php

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