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.