Following the announcement of the proposed risk based self care product regulatory framework, Health Canada has undertaken several consultations with stakeholders. The consultation process provides more information, allows stakeholders to ask questions and provide feedback. Several refinements to the proposed framework have been made which are currently being discussed in the second round of consultations.
A two-category model has been proposed, further subdivided into different subsections and pathways depending on the type of product, level of risk, ingredients, claims permitted and evidence required. A key change resulting from the first round of consultations is a distinction between products that make therapeutic claims and those that do not.
Health Canada’s Ministerial Abilities
Under the proposed framework Health Canada would have the ability to:
- Request product information related to safety, efficacy, or quality
- Refuse or reject a registration under reasonable grounds, such as an unacceptable ingredient
- Cancel a registration under reasonable grounds, such as indication the product poses a risk
- Reconsider a registration refusal/cancellation
- Request additional information to support registration, such as testing
- Recall or order measures such as stop sale or request discontinuance of an activity
- Issue administrative monetary penalties
In order to assist consumers with product identification, selection and use, several product labelling refinements have been added to the proposed framework.
- Web addresses to additional product information
- A “Health Facts Table” for Category IB and II (analogous to Drug Facts Table)
- Positive statements or symbols to help distinguish between self care products that would not negate Health Canada’s position on claims (e.g. “homeopathic self care product”, “self care product based on historical use”)
- Introduce rule to improve allergen disclosure
- Simplify label content (in particular for risks and warning statements) and remove other unnecessary content
Site Licencing, Quality Standards and Cost Recovery
A new set of standards would be developed rather than adopting the current GMP for NHPs and Drug products.
- Site licenses and annual renewal would be required for Category IB and II products
- Baseline quality manufacturing standards would be established that are consistent across all product lines, with increased requirements for Category IB and II products
- Fees would apply to all self-care products, with new fee introductions subject to detailed consultations
- Fees would be directly indexed against the cost of the activity being charged with key considerations being remission, fee structure, annual renewal fees, and cost sharing
Post Market Vigilance and Enforcement
More proactive post market compliance and inspection has been proposed, as well as a simplified process for reporting non-compliance complaints.
- A risk based approach to vigilance would be established
- Health Canada would have the power to address non-compliance and safety concerns
- Border Compliance Verification requirements
- Category IA products must have proof of registration
- Category IB products must be provide proof of registration and have appropriate site licensing at time of importation
- Category II products must hold applicable product and site licence
How Can You Get Involved in the Consultations?
The proposed risk based regulatory framework for self care products is a pioneering step in regulatory affairs. It seeks to provide more predictable, consistent and risk based rules for bringing products to market, while providing consumers with continued access to a wide range of safe and effective self care products. It also supports informed decision making with better information, clarity, and transparency.
To participate in the remaining Phase 2 consultations, please follow the links below:
|June 27, 2017||1:00pm – 4:30am EDT||Montreal, QC|
|June 29, 2017||9:00am-12:00pm HAE||Online (French)|
|June 29, 2017||1:00pm-4:00pm EDT||Online (English)|
For more information:
Health Canada self care products website- www.canada.ca/selfcare-products
Contact the Health Canada self-care products team- firstname.lastname@example.org
If you need assistance determining how the proposed regulatory framework may affect your consumer products, please do not hesitate to contact Focal Point Research Inc. We are leading Canadian Regulatory Consultants for Natural Health Products, OTC Drugs, Cosmetics, and other personal care products.