The Human Medicines Regulations 2012

Exemption for supply by national health service bodies

229.—(1) Regulations 214(1), 220 and 221 do not apply to the supply of a medicinal product in accordance with condition A or B by—

(a) the Common Services Agency;

(b) a health authority or special health authority;

(c) an NHS trust;

(d) an NHS foundation trust;

(e) a Primary Care Trust; or

(f) a person who is not a doctor, dentist or person lawfully conducting a retail pharmacy business, where the person supplies the product pursuant to an arrangement with one of the persons specified in paragraphs (a) to (e).

(2) Condition A is that the product is supplied for the purpose of being administered to a person in accordance with the written directions of a doctor, dentist, nurse independent prescriber, optometrist independent prescriber or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

(3) Condition B is that—

(a) the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”);

(b) the PGD relates to the supply of a description or class of medicinal product by the person by whom the medicinal product is supplied and has effect at the time at which it is supplied;

(c) the PGD contains the particulars specified in Part 1 of Schedule 16;

(d) the PGD is signed on behalf of the person specified in column 2 of the table in Part 2 of that Schedule (“the authorising person”) against the entry in column 1 of that table for the class of person by whom the product is supplied;

(e) the individual who supplies the product—

(i) belongs to one of the classes of individual specified in Part 4 of that Schedule, and

(ii) is designated in writing, on behalf of the authorising person, for the purpose of the supply or administration of products under the PGD; and

(f) when the product is supplied, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in relation to it.