The Human Medicines Regulations 2012

Sale or supply of prescription only medicines U.K.

214.—(1) A person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.

(2) A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person is—

(a) an appropriate practitioner other than an [F1 approved country health professional]; or

(b) acting in accordance with the directions of such an appropriate practitioner.

(3) The following are appropriate practitioners in relation to any prescription only medicine—

(a) a doctor;

(b) a dentist;

(c) a supplementary prescriber;

(d) a nurse independent prescriber; and

(e) a pharmacist independent prescriber.

(4) A community practitioner nurse prescriber is an appropriate practitioner in relation to a prescription only medicine specified in Schedule 13.

(5) An optometrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine other than—

(a) a medicinal product that is a [F2 product subject to special medical prescription]; or

(b) a medicinal product that is for parenteral administration.

[F3 (5A) A podiatrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a [F4 product subject to special medical prescription] other than—

(a) Dihydrocodeine: or

(b) Temazepam.

(5B) A physiotherapist independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a [F5 product subject to special medical prescription] other than—

(a) Dihydrocodeine;

(b) Fentanyl;

(c) Morphine;

(d) Oxycodone; or

(e) Temazepam.]

[F6 (5C) A therapeutic radiographer independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a) Codeine;

(b) Fentanyl;

(c) Midazolam;

(d) Morphine;

(e) Oxycodone;

(f) Temazepam; or

(g) Tramadol.]

[F7 (5D) A paramedic independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a) Codeine;

(b) Fentanyl;

(c) Midazolam; or

(d) Morphine.]

(6) An [F8 approved country health professional] is an appropriate practitioner in relation to any prescription only medicine other than a [F9 product subject to special medical prescription].

[F10 (6A) The licensing authority must publish a list of approved countries and professions for the purposes of the definition of “approved country health professional”.

(6B) In order to determine whether a country or profession should be included in the list published under paragraph (6A), the licensing authority may, in particular, take into account—

(a) the country's standards of professional qualification;

(b) the country's system for ensuring that qualified professionals have undergone training which meets the requirements that apply in that country;

(c) the effectiveness of enforcement of professional standards;

(d) the mechanisms the country has in place to assist members of the public in obtaining information in respect of a qualified professional who is established there; and

(e) the regularity and rapidity of information provided by that country relating to non-compliant professionals.

(6C) The licensing authority must—

(a) review a country or profession it has included in the list published under paragraph (6A) to determine if it is still satisfied that they should remain on the list, and if it is not so satisfied, remove it from that list; and

(b) undertake such a review at least every 3 years beginning with the date on which that country or profession was included in that list.]

(7) This regulation is subject to Chapter 3 (exemptions).

Textual Amendments

F1 Words in reg. 214(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 180(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 214(5)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

F3 Reg. 214(5A)(5B) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 26

F4 Words in reg. 214(5A) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5A) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

F5 Words in reg. 214(5B) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5B) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

F6 Reg. 214(5C) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 9 and reg. 214(5C) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 9

F7 Reg. 214(5D) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 6 and reg. 214(5D) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 6

F8 Words in reg. 214(6) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 180(3); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in reg. 214(6) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(6) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

F10 Reg. 214(6A)-(6C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 180(4); 2020 c. 1, Sch. 5 para. 1(1)