Consultation - Consumer Health Products Framework
Notice to the reader:The online consultation is now closed. A summary report of the feedback received can be found below.
Further to the ministerial announcement on June 9, 2014, Health Canada is consulting on a new framework that seeks to establish a consistent and aligned approach to the regulation of health products intended for consumer use (disinfectants, natural health products, non-prescription drug products and cosmetics).
Consumer health products are regulated under several sets of regulations, each with its own requirements. Because some requirements are considerably more stringent than others, products of similar risk can be subject to very different requirements. This can result in disproportionate application. This is most evident in the case of non-prescription drugs, which are regulated using the same out-dated set of regulations as prescription drugs.
Moreover, many consumer health products border or sit at the interface of multiple product categories that are defined in regulation and policy. This means that a single product can have multiple features of different product categories at one time. For example, a cream could be a natural health product, a non-prescription drug, or a cosmetic depending on the product's ingredients, whether it claims to have an impact on the user's health, and other factors.
What is the Consumer Health Products Framework?
The Consumer Health Products Framework includes the policy/guidance, operational and regulatory oversight of the following products:
- Non-prescription drugs
- Natural health products
Under the Consumer Health Products Framework (Framework), Health Canada will advance a new approach to the regulation of consumer health products that will establish a consistent and aligned approach for these products while continuing to ensure that Canadians have access to safe and effective products.
The key part of the approach is the proposal to create new regulations for non-prescription drugs, supported by ongoing operational improvements.
The best elements of the Food and Drug Regulations combined with experience gained from administering regulations such as the Natural Health Products Regulations will inform the creation of a modern, comprehensive and risk-based set of regulations for non-prescription drugs.
This will also help create fluidity between regulations such as the Natural Health Products Regulations and the Cosmetic Regulations. This approach will continue to ensure Canadians can have confidence in the safety of health products they use.
This consultation document will explain the importance of creating new non-prescription drug regulations to support the success of the overall Consumer Health Products Framework. It will also explain how the Framework and the proposed regulations are designed to ensure that the safety of Canadians always remains the priority.
As part of the Regulatory Transparency and Openness Framework, Health Canada is inviting all Canadians to be a part of the discussion on the future regulation of consumer health products. However, it is recognized that the technical details are likely more relevant to industry stakeholders - small businesses, retailers, industry associations, etc. Questions have been developed to collect information on individual elements of the Framework as well as on the proposed non-prescription drug regulations.
The consultation document is available as follows:
The consultation document was posted on Health Canada's website for comment from November 27, 2014 until February 27, 2015. Health Canada received over 300 pages of comments submitted by 31 respondents. A summary report of 'What We Heard' is available here:
Reporting to Canadians
The feedback received from this consultation will help Health Canada understand the impacts of the proposed changes, shape the Framework, and inform the regulatory development process for the proposed non-prescription drug regulations.
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