Ministerial Notice to Stakeholders - Consultations on a Consumer Health Products Framework
June 9, 2014
Ottawa - Health Canada will launch consultations this fall on a new framework aimed at streamlining and updating the current regulations for certain lower-risk health products such as cosmetics, currently defined as drugs under the Food and Drugs Act, and hard surface disinfectants.
As part of these consultations, it is proposed that lower-risk products be separated from the framework for prescription drugs, and be moved under a new framework for consumer health products. The new framework will take into account the potential risk of the product in order to ensure that the right level of oversight through regulations is applied. As always, the health and safety of Canadians will remain the first priority, and Health Canada will continue to require that the benefits of any product outweigh the risks.
These consultations will build on existing efforts to reduce unnecessary red tape for consumer health products where it makes sense, such as cosmetics with health claims and disinfectants. These initiatives are in keeping with the Government's overall strategy as part of the Regulatory Cooperation Council Action Plan.
Health Canada recently revised disinfectant guidance documents, creating flexibility and the appropriate regulatory oversight for these lower-risk products. The Department will continue to advance operational improvements over the next 18 months, while the proposed regulations are being developed.
Key facts:
- This work is part of the Health Products and Food Regulatory Roadmap. The goal of the Roadmap is to move to a streamlined, more efficient and transparent regulatory system that enhances consumer safety, reduces burden, fosters innovation and accountability, and helps deliver a variety of health options to Canadian families. This will include further amendments to the Food and Drugs Regulations.
- Vanessa's Law (Bill C-17) will introduce targeted new measures for prompt action on pharmaceutical drugs and medical devices that demonstrate unacceptable risks to Canadians. These measures include the power to recall unsafe drugs, impose stiff financial penalties, and require mandatory adverse reaction reporting by healthcare facilities. These consultations will ensure that the new authorities in Bill C-17 will focus on products that pose a risk to Canadians, while providing appropriate oversight for lower risk products such as sunscreen.
- Health Canada is acting to ensure the appropriate regulation of lower-risk products, while maintaining strong oversight of any health product that may pose a risk to Canadians.
- Stakeholders will be invited to provide feedback on the Consumer Health Product Framework for a 60 day period.
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