On June 22, 2013, proposed regulations amending the Food and
Drug Regulations relating to the labeling of prescription and
non-prescription drug products were published for a 75-day comment
period. Comments are due by September 6, 2013. The aim
of the proposal is to require product labels to be clearer, more
accurate and easier to understand. The proposal also
introduces, among other elements, the regulatory authority for the
Minister of Health to require from a product sponsor an assessment
of the potential for medication confusion due to product names.
The proposed regulations would change the current system as
Contact information on labels to report
problems: Currently, drug labels already include
this information; the proposal aims to allow flexible options such
as a toll-free number, email address, or Web site, to be identified
for contacting the Canadian person who is responsible for the
Standard table format for non-prescription drug
labels: Currently, significant information must be
included on the drug label; the proposal would require the
information to be in a certain table format, helping users locate
and read information and make informed decisions.
Submission of mock-ups of labels and packages:
Currently, manufacturers submit written text or drafts for
pre-market review, with final labels only submitted once a product
is on the market. The proposal would require submission of
mock-ups of the label and package, so the actual packaging and
labeling would be agreed upon at the time a product is
Submission of an assessment that a drug would not be
confused with another drug because of similar names:
Currently there is no actual regulation requiring
manufacturers to submit an assessment that its drug would not
likely be mistaken for another drug (though the ability for Health
Canada do so is stated to exist in broader authority). The
proposed regulations would make this requirement specific.
The process for drug manufacturers to ensure that drug names are
not confusing has been in place at Health Canada since 2006.
Recently, Health Canada conducted consultations on revising
the current policy, and in particular, setting out in more detail
the kinds of information that should be provided to Health Canada
so that it may determine whether there is potential for confusion
between two product names; see "Draft Revised Guidance
Document for Industry – Review of Drug Names for Look-alike
Sound-alike (LASA) Attributes) at http://www.hc-sc.gc.ca/dhp-mps/consultation/medeff/_2013/lasa-pspcs/lasa-pspcs-eng.php.
The consultation proposed moving to a multi-step testing of
proposed brand names, including name searching, simulations, and
synthesizing the information obtained through searching and
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Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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