The Human Medicines Regulations 2012

Exemption for supply by national health service bodies [F1and local authorities] U.K.
This section has no associated Explanatory Memorandum

229.—(1) Regulations 214(1) [F2and (2)], 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;

[F3(da)a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); F4...]

[F5(db)the United Kingdom Health Security Agency;]

(dc)Public Health Agency; or

F6(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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 [F7[F8an integrated care board], [F9NHS England] or] one of the persons specified in paragraphs (a) [F10to [F11(dc)]].

(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 [F12, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber] [F13, paramedic independent prescriber] or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

[F14(2A) In relation to a medicinal product that is for parenteral administration, condition A only applies if the person who has given the written directions is an appropriate practitioner in relation to that medicinal product.]

(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

[F15(f)when the product is supplied [F16, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(i)in Northern Ireland, a UKMA(NI), UKMA(UK)F17..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F18or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

(ii)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.]

F19(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F4Word in reg. 229(1)(da) omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(a) and word in reg. 229(1)(da) omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(a)

F11Word in reg. 229(1)(f) substituted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(c) and word in reg. 229(1)(f) substituted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(c)

F12Words in reg. 229(2) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 11 and words in reg. 229(2) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 11

F13Words in reg. 229(2) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 9 and words in reg. 229(2) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 9