NOTIFICATION
Addendum
The following communication, dated 29 August
2024, is being circulated at the request of the delegation of Canada.
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Title:
Supplementary Rules Respecting Nicotine Replacement Therapies Order
Description: The Supplementary Rules Respecting
Nicotine Replacement Therapies Order (this Order) applies to nicotine
replacement therapies (NRTs)s for administration in the oral cavity that are
regulated under the Natural Health Products
Regulations for use in smoking cessation by adults who smoke. This
Order introduces new measures that:
·_
Incorporate
by reference the List of Nicotine Replacement Therapy Dosage Forms that may be
Accessible for Self-selection by Purchasers or Consumers (the List);
·_
Prohibit
direct public access to dosage forms of NRTs that have a limited history of
appropriate use, which are not on the List, by requiring that they be sold by a
pharmacist or someone under their supervision and are otherwise inaccessible
for self-selection;
·_
Require
warnings about the addictive nature of nicotine and statements conveying the
intended subpopulation (i.e., individuals 18 years of age or older) on product
labels and in advertisements;
·_
Restrict
advertising and promotion that could be appealing to young people or if they
convey a use other than the product's intended use (i.e., smoking cessation);
·_
Restrict
packaging and labelling that could be appealing to young people; and
·_
Prohibit
persons from manufacturing or selling NRTs that are in certain flavours as
outlined in the Order.
The Order comes into force immediately upon publication. At
this time, NRTs must not be manufactured or sold unless they are compliant with
the flavour restrictions set out in the Order and NRTs in dosage forms not on
the List must not be sold on a retail basis except by a pharmacist or an
individual working under the supervision of a pharmacist.
The Order provides a six-month transition period to come
into compliance with requirements of the Order that relate to packaging and
labelling, and advertising and promotion. In addition, the Order provides for
the sale of an NRT that is not labelled or packaged in accordance with the
Order if it was labelled prior to the coming into force of the Order, or, if
the NRT was imported, it was imported and labelled in accordance with the Natural Health Products Regulations prior
to the coming into force of the Order.
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[1] This information can be provided by including a website address, a
pdf attachment, or other information on where the text of the final/modified
measure and/or interpretive guidance can be obtained.