As part of the Jobs, Growth and Long-term Prosperity
Act (Bill C-38), which received Royal Assent on June 29, 2012,
the Canadian Government amended the Food and Drugs Act so
that the Minister of Health could establish a list of prescription
drugs to replace the existing Schedule F to the
Regulations. In addition to the creation of the
List, the regulatory process to add a drug to, or remove a
drug from, Schedule F will be replaced by an administrative process
where drugs can be classified, or declassified, as prescription
drugs in less time. Currently, a regulatory amendment (which
requires approval from the Governor in Council) is needed to give a
drug prescription status by adding it to Schedule F, or to switch
its status from prescription to non-prescription by removing it
from Schedule F. The objective of the proposed changes is to gain
efficiencies for Health Canada by moving towards a less burdensome
non-regulatory approach for maintaining the list of prescription
The List sets out drugs and classes of drugs that are
divided based on medicinal ingredients for human and veterinary
use. Of note, drugs that are currently listed in Schedule F will
also be included in the List.
In addition to repealing Schedule F, the proposed regulatory
amendments describe the process involved in determining whether to
add a drug to, or remove a drug from, the List and
specifically outlines the principles that Health Canada will
consider in making these determinations, including whether:
(a) supervision by a practitioner is necessary
(i) for the diagnosis, treatment, mitigation or prevention of a
disease, disorder or abnormal physical state, or its symptoms, in
respect of which the drug is recommended for use, or (ii) to
monitor a disease, disorder or abnormal physical state, or its
symptoms, in respect of which the drug is recommended for use, or
to monitor the use of the drug;
(b) the level of uncertainty respecting the drug, its use or its
effects justifies supervision by a practitioner; or
(c) use of the drug can cause harm to human or animal health or
a risk to public health and the harm or the risk can be mitigated
by a practitioner's supervision.
If one or more of the above principles apply, the drug will
typically be classified as a prescription drug. However, there may
be cases where, in the interest of an individual, public or animal
health, exceptions are made (e.g., flu vaccines are not
prescription drugs so that large public vaccination campaigns can
be undertaken in the interest of individual and public health).
The draft guidance document replaces Health Canada's policy
on Factors for Listing Drugs in Schedule F and supports
the proposed regulatory amendments by providing detailed
explanations of the aforementioned principles.
Importantly, this new approach is not intended to impact the
safety, quality and efficacy of drugs in Canada. Health Canada has
indicated that all drug submissions will continue to be subject to
the same scientific assessments prior to determining whether to
classify a drug as a prescription drug. The changes are also not
intended to affect the regulation of prescription drug sales,
advertising, or importation in Canada.
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