Exception for medicines indicated for the treatment of persons aged under 186

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 use6;

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.