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The Human Medicines Regulations 2012

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The Human Medicines Regulations 2012, Section 214 is up to date with all changes known to be in force on or before 22 November 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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Sale or supply of prescription only medicinesU.K.
This section has no associated Explanatory Memorandum

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 [F1approved 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 [F2product 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 [F4product 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 [F5product 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 [F8approved country health professional] is an appropriate practitioner in relation to any prescription only medicine other than a [F9product 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

F2Words 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)

F4Words 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)

F5Words 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)

F6Reg. 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

F9Words 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)

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