The Human Medicines Regulations 2012

Packaging requirements: specific provisions U.K.

258.—(1) In addition to other information required by this Part, the information specified in Part 1 of Schedule 25 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product sold or supplied in accordance with a prescription given by a person who is an appropriate practitioner for the purposes of regulation 214(3) to (6), whether or not the medicinal product in question is a prescription only medicine.

(2) The requirements of paragraph 4 or 6 of Schedule 25, as the case may be, are satisfied in relation to a package containing a number of packages of medicinal products of the same description if the information specified in paragraph 4 or 6 of that Schedule is shown on one or more of those packages.

(3) The information specified in Part 2 of that Schedule must appear on a package which contains a number of packages of medicinal products of the same description, other than special medicinal products, for the purpose of transport, delivery or storage.

(4) But paragraph (3) does not apply to a packing case, crate or other covering used solely for the purposes of transport or delivery of packages of medicinal products, each of which is labelled in accordance with the other requirements of this Part.

(5) In addition to the other information required by this Part, the information specified in Parts 3 and 4 of Schedule 25 must appear on the outer packaging and the immediate packaging of products of the kind specified in those Parts of that Schedule.

(6) Nothing in this regulation or Schedule 25 requires information to appear on—

(a) a package containing a medicinal product where part of the package is transparent or open, provided that the information required by this regulation and that Schedule is clearly visible through the transparent or open part of the package;

(b) a paper bag or similar wrapping in which a package that contains a medicinal product and bears information in accordance with the requirements of this regulation and that Schedule is placed at the time of sale or supply;

(c) a package enclosing a package of a medicinal product for export;

(d) an ampoule or other container of not more than 10 millilitres' nominal capacity which is enclosed in a package on which information appears in accordance with the requirements of this regulation and that Schedule; or

(e) a blister pack or similar packaging enclosed in a package on which information appears in accordance with the requirements of Parts 3 and 4 of Schedule 25.

(7) Nothing in this regulation or Schedule 25 applies to a medicinal product—

(a) which is an anti-viral medicine in the form of a solution to be used for the treatment of a child under the age of one year;

(b) on the container of which appears—

(i) the name of the person to whom the product is to be administered,

(ii) the date on which the product is sold or supplied, and

(iii) the necessary instructions for proper use; and

(c) which is sold or supplied for the purpose of treating a disease which is—

(i) a serious risk to human health, or potentially a serious risk to human health, and

(ii) pandemic or imminently pandemic.

(8) Nothing in this regulation or Schedule 25 applies to a traditional herbal medicinal product or a registrable homoeopathic medicinal product.