Protection of
Children (Nicotine Inhaling Products) (Jersey) Regulations 2016
1 Interpretation
In these Regulations –
“appropriate practitioner” means a person of a
description or class specified by Order under Article 57(1)(b) of the Medicines
Law;
“Medicines Law” means the Medicines (Jersey) Law 1995;
“medical device” means any instrument, apparatus,
appliance, software, material or other article, whether used alone or in
combination, together with any accessories, including the software intended by
its manufacturer to be used specifically for diagnosis or therapeutic purposes
or both and necessary for its proper application, which –
(a) is
intended by the manufacturer to be used for human beings for the purpose of –
(i) diagnosis,
prevention, monitoring, treatment or alleviation of disease,
(ii) diagnosis,
monitoring, treatment, alleviation of or compensation for an injury or
handicap,
(iii) investigation,
replacement or modification of the anatomy or of a physiological process, or
(iv) control
of conception; and
(b) does
not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, even if it is assisted in
its function by such means,
including devices intended to
administer a medicinal product or which incorporate as an integral part a
substance which, if used separately, would be a medicinal product and which is
liable to act upon the body with action ancillary to that of the device;
“medicinal product” has the same meaning as in Article 2
of the Medicines Law;
“nicotine cartridge” means a cartridge
which –
(a) contains
a substance which is not tobacco but consists of, or contains, nicotine; and
(b) is
intended to form part of a nicotine inhaling device;
“nicotine inhaling device” means a device
which –
(a) is
intended to enable nicotine to be inhaled through a mouth piece (regardless of
whether the device is also intended to enable any other substance to be inhaled
through a mouth piece); but
(b) is
not tobacco, cigarette papers or a device intended to be used for the
consumption of ignited tobacco;
“nicotine inhaling product” means a nicotine inhaling
device, nicotine cartridge or nicotine refill substance;
“nicotine refill substance” means a substance
which –
(a) is
not tobacco but consists of, or contains, nicotine; and
(b) is
intended to be used to refill a nicotine inhaling device;
“prescription only medicine” means a medicinal product
specified in an Order under Article 57(1)(a) of the Medicines Law;
“supply” includes the act of selling and the act of
making a gift.
2 Prohibition
on supply of nicotine inhaling products to children
The supply of any nicotine inhaling product to any person under the
age of 18 years is prohibited except where Regulation 3 or 4
applies.
3 Exception
for supply of nicotine inhaling products indicated for the treatment of persons
aged under 18
(1) Regulation 2 does
not apply to the supply of a nicotine inhaling product which –
(a) is an
authorized medicinal product; and
(b) is
indicated for the treatment of persons of the age of the person to whom the
product is supplied.
(2) For the purposes of
this Regulation –
(a) a
medicinal product is “authorized” if a product licence granted for
the purposes of Article 8 of the Medicines Law is in force which is
applicable to it; and
(b) a
nicotine inhaling product is indicated for the treatment of persons of a
particular age if it is described as such –
(i) in the clinical
particulars for the product in accordance with paragraph 9(d) of Schedule 1
to the Medicines (Applications for
Licences for Products for Human Use) (Jersey) Order 1997, or
(ii) in
accordance with paragraph (4).
(3) The reference to a
“product licence” in paragraph (2)(a) includes a valid United
Kingdom product licence or a valid marketing authorization which has effect as
if it were a product licence in accordance with Article 7(2) of the Medicines
Law.
(4) Where a medicinal
product is authorized by virtue of a product licence described in paragraph (3),
a nicotine inhaling product is indicated for the treatment of persons of a
particular age if it is described as such in accordance with
Regulation 5(2)(a) of the Nicotine Inhaling Products (Age of Sale and
Proxy Purchasing) Regulations 2015 of the United Kingdom.
4 Exception
for supply of nicotine inhaling products as if they were prescription only
medicines
Regulation 2 does not apply to supply of a nicotine inhaling
product where –
(a) the nicotine inhaling
product is a medicinal product or a medical device; and
(b) the circumstances of
the supply are such that, if the nicotine inhaling product were a prescription
only medicine, its supply would be permitted under Article 57 of the Medicines
Law (including any exemption under that Article).
5 Citation
These Regulations may be cited as the Protection of Children
(Nicotine Inhaling Products) (Jersey) Regulations 2016.