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) or Article 11 of Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community code relating to medicinal products for human use (1);

(b) “the summary of the product characteristics” is to be construed in accordance with Article 11 of Directive 2001/83/EC;

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

(i) a marketing authorisation; or

(ii) a parallel import licence.

(1)

Directive 2001/83/EC (OJ No. L 311, 28.11.2001), as amended by Directive 2012/26/EU (OJ No. L 299, 27.10. 2012, p.1).