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
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
Consumers and those involved in the industry are encouraged to
provide comments using the online portal.
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