Exception for medicines indicated for the treatment of persons aged under 18E+W
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) F1...;
F2(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c)a medicinal product is “authorised” if one of the following is in force for the product—
(i)a [F3UK] marketing authorisation; or
(ii)a parallel import licence.
Textual Amendments
F1Words in reg. 5(2)(a) omitted (31.12.2020) by virtue of The Tobacco Products and Nicotine Inhaling Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/41), regs. 1, 5(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 5(2)(b) omitted (31.12.2020) by virtue of The Tobacco Products and Nicotine Inhaling Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/41), regs. 1, 5(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in reg. 5(2)(c)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 13(3); 2020 c. 1, Sch. 5 para. 1(1)