Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015.

(2) Regulations 1 and 2 come into force on the day after the day on which these Regulations are made.

(3) Regulations 3 to 7 come into force on 1st October 2015.

(4) In these Regulations—

“ UK marketing authorisation ” has the meaning given by regulation 8(1) of the Human Medicines Regulations 2012 ;

“ medical device ” has the meaning given by regulation 2(1) of the Medical Devices Regulations 2002 ;

“ medicinal product ” has the meaning given by regulation 2(1) of the Human Medicines Regulations 2012;

“ nicotine cartridge ” means a cartridge which—

“ nicotine inhaling device ” means a device which—

“ nicotine inhaling product ” means a nicotine inhaling device, nicotine cartridge or nicotine refill substance;

“ nicotine refill substance ” means a substance which—

“ parallel import licence ” has the meaning given by regulation 48(2) of the Human Medicines Regulations 2012;

“ prescription only medicine ” has the meaning given by regulation 8(1) of the Human Medicines Regulations 2012.

Proxy purchase of nicotine products

2. —(1)Section 91 of the Children and Families Act 2014(purchase of tobacco etc. on behalf of persons under 18) is amended in accordance with paragraphs (2) to (4).

(2) In the heading, before “etc.” insert “ , nicotine products ” .

(3) In subsection (1), for “or cigarette papers” substitute “ , cigarette papers or a relevant nicotine product ” .

(4) After subsection (7) add—

“ (8) In this section “ relevant nicotine product ” means a nicotine product within the meaning of section 92 the sale of which at the same time and in the same circumstances to the individual aged under 18 would be prohibited by regulations for the time being in force under subsection (1) of that section. ” .

Prohibition of sale of nicotine inhaling products to persons aged under 18

3. The sale of nicotine inhaling products to persons aged under 18 is prohibited, except where regulation 4 or 5 applies.

Exception for sales of medicines and medical devices in accordance with a prescription etc.

4. —(1) This regulation applies to the sale 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 sale are such that it would be permitted under Part 12 of the Human Medicines Regulations 2012 (dealings with medicinal products) if the nicotine inhaling product were a prescription only medicine.

(2) For the purposes of paragraph (1)(b), Part 12 of the Human Medicines Regulations 2012 is to be read as if regulation 244 (exemption in cases involving another's default) were omitted.

Exception for medicines indicated for the treatment of persons aged under 18

5. —(1) This regulation applies to the sale of a nicotine inhaling product which—

(a) is an authorised medicinal product; and

(b) is indicated for the treatment of persons of the age of the person to whom the product is sold.

(2) For the purposes of this regulation—

(a) a product is indicated for the treatment of persons of a particular age if it is described as such in the summary of the product characteristics for the product in accordance with paragraph 27 of Schedule 8 to the Human Medicines Regulations 2012 (summary of the product characteristics) ...

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) a medicinal product is “authorised” if one of the following is in force for the product—

(i) a UK marketing authorisation; or

(ii) a parallel import licence.

Amendment of Schedule 3 to the Regulatory Enforcement and Sanctions Act 2008

6. In Schedule 3 to the Regulatory Enforcement and Sanctions Act 2008(enactments specified for the purposes of Part 1), at the appropriate place insert—

“ Children and Families Act 2014 (c.6), section 92 ” .

Review

7. —(1) The Secretary of State must from time to time—

(a) carry out a review of regulations 3 to 5 including the definitions of “nicotine cartridge”, “nicotine inhaling device”, “nicotine inhaling product” and “nicotine refill substance” in regulation 1(4),

(b) set out the conclusions of the review in a report, and

(c) publish the report.

(2) The report must in particular—

(a) set out the objectives intended to be achieved by the regulatory system established by those regulations,

(b) assess the extent to which those objectives are achieved, and

(c) assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(3) The first report under this regulation must be published before the end of the period of five years beginning with 1st October 2015.

(4) Reports under this regulation are afterwards to be published at intervals not exceeding five years.