Health Canada released details on a proposed new regulatory framework for consumer health products (“CHPs”) that will include non-prescription drugs, cosmetics, disinfectants and natural health products (“NHPs”). The CHP regulatory framework is intended to create a consistent and aligned approached for the regulation of CHPs in Canada, and apply the level of oversight that is appropriate to the potential risk associated with these products.
Currently, CHPs may fall under one of several different regulatory frameworks, resulting in products with similar risks being subject to very different regulatory requirements.Notably, non-prescription drugs and disinfectants are classified as drugs and subject to many of the same regulatory requirements as prescription drugs, whereas NHPs have their own regulations. In order to address this issue, Health Canada proposes to develop a new set of regulations for non-prescription drugs and manage all CHPs under a common framework.
The proposed CHP framework is available here and will remain open for consultation until Friday, Feb. 27, 2015. The framework includes explanations and rationales of the key part of the proposed non-prescription drug regulations (see Part 3).
Some of the elements of the proposed non-prescription drug regulations include: packaging and labelling, adverse reaction reporting, record-keeping, samples, advertising, marketing authorizations, good manufacturing practices, establishment licensing and clinical trials. Unlike the current Natural Health Products Regulations, it is intended that the non-prescription regulations will include an exemption to permit the distribution of product samples in compliance with certain rules (to be developed). If a consistent and aligned approach is the goal of the new framework, this seems like an opportunity to extend the same exemption to NHPs at the same time.
One issue that is not addressed in the framework is an exemption for CHPs from the definition of “therapeutic products” in the Food and Drugs Act (FDA) – a new term introduced by the passage of Vanessa’s Law (Bill C-17) in November 2014. When Vanessa’s Law was passed, NHPs were specifically excluded from the definition of “therapeutic products” while other CHPs (i.e. non-prescription drugs and disinfectants) were not. Without an amendment to the FDA to exclude all CHPs, these products will continue to be subject to the more onerous requirements targeted at therapeutic products (including prescription drugs).
Consumers and those involved in the industry are encouraged to provide comments using the online portal.