The Human Medicines Regulations 2012

CHAPTER 2 U.K. Sale and supply of medicines

Prescription only medicines U.K.

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 EEA 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 [F1 product subject to special medical prescription]; or

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

[F2 (5A) A podiatrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a [F3 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 [F4 product subject to special medical prescription] other than—

(a) Dihydrocodeine;

(b) Fentanyl;

(c) Morphine;

(d) Oxycodone; or

(e) Temazepam.]

[F5 (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.]

[F6 (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 EEA health professional is an appropriate practitioner in relation to any prescription only medicine other than a [F7 product subject to special medical prescription].

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

Textual Amendments

F1 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)

F2 Reg. 214(5A)(5B) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 26

F3 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)

F4 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)

F5 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

F6 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

F7 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)

Prescribing and administration by supplementary prescribers U.K.

215.—(1) A supplementary prescriber (“S”) may not give a prescription for a prescription only medicine unless S meets conditions A and C.

(2) A supplementary prescriber (“S”) may not—

(a) parenterally administer a prescription only medicine; or

(b) give directions for the parenteral administration of a prescription only medicine,

unless S meets conditions B and C.

(3) Condition A is that S is acting in accordance with the terms of a clinical management plan that—

(a) relates to the patient to whom the product is prescribed;

(b) has effect when the prescription is given; and

(c) includes the particulars specified in Schedule 14.

(4) Condition B is that S is acting in accordance with the terms of a clinical management plan that—

(a) relates to the patient to whom the product is, or is to be, administered;

(b) has effect when the product is administered or (as the case may be) the direction is given; and

(c) includes the particulars specified in Schedule 14.

(5) Condition C is that S has access to health records that—

(a) are the health records of the patient to whom the plan relates; and

(b) are used by any doctor or dentist who is a party to the plan.

(6) This regulation is subject to regulation 216.

(7) In this regulation—

“clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a)

the patient to whom the plan relates;

(b)

the doctor or dentist who is a party to the plan; and

(c)

any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;

“health record” has the meaning given by section 68(2) of the Data Protection Act 1998 M1 .

Marginal Citations

M1 1998 c.29.

Exceptions to regulation 215 U.K.

216.—(1) Regulation 215 does not apply if—

(a) S is a community practitioner nurse prescriber; and

(b) the prescription only medicine prescribed or administered, or in respect of which S gives directions for administration, is specified in Schedule 13.

(2) Regulation 215(2) does not apply if S is acting in accordance with the directions of another person who is an appropriate practitioner (other than a supplementary prescriber or an EEA health professional) in relation to the prescription only medicine in question.

Requirements for prescriptions: general U.K.

217.—(1) For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner unless the following conditions are met.

(2) Condition A is that the prescription is signed in ink by the appropriate practitioner giving it.

(3) Condition B is that the prescription—

(a) is written in ink or otherwise so as to be indelible; or

(b) in the case of a health prescription which is not for a [F8 product subject to special medical prescription], is written as described in sub-paragraph (a) or by means of carbon paper or similar material.

(4) Condition C is that the prescription contains the following particulars—

(a) the address of the appropriate practitioner giving it;

(b) the appropriate date;

(c) an indication of the kind of appropriate practitioner giving it;

(d) the name and address of the person for whose treatment it is given; and

(e) if that person is under 12, that person's age.

(5) Condition D is that the prescription—

(a) is not dispensed after the end of the period of six months beginning with the appropriate date; or

(b) in the case of a repeatable prescription—

(i) it is not dispensed for the first time after the end of that period, and

(ii) it is dispensed in accordance with the directions contained in the prescription.

(6) Condition E is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a) it is not dispensed on more than two occasions, or

(b) in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the appropriate date.

(7) In this regulation “appropriate date” means, subject to paragraph (8)—

(a) in the case of a health prescription, whichever is the later of—

(i) the date on which it was signed by the appropriate practitioner giving it, or

(ii) a date indicated by the appropriate practitioner as the date before which it should not be dispensed; and

(b) otherwise, the date on which the prescription was signed by the appropriate practitioner giving it.

(8) This regulation—

(a) does not apply to a prescription given by an EEA health professional (as to which see regulation 218); and

(b) is subject to regulation 219 (electronic prescriptions).

Textual Amendments

F8 Words in reg. 217(3)(b) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(b) and words in reg. 217(3)(b) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(b)

[F9 Requirements for prescriptions to be dispensed in an EEA state other than the UK U.K.

217A.— (1) In this regulation—

“B” means a person who is an appropriate practitioner for the purposes of regulation 214(3) to (5B);

“P” means a person who is the patient of B.

(2) The information specified in paragraph (3) is to be included in any prescription where—

(a) P requests a prescription that is to be dispensed in an EEA state other than UK; and

(b) B determines that such a prescription is appropriate.

(3) The specified information is—

(a) the patient’s—

(i) surname,

(ii) first names written out in full, and

(iii) date of birth;

(b) the issue date of the prescription;

(c) B’s—

(i) surname,

(ii) first names written out in full,

(iii) professional qualification,

(iv) direct contact details including—

(aa) email address,

(bb) telephone or fax number with the appropriate international prefix,

(v) work address,

(vi) confirmation that B works as a health professional in the UK, and

(vii) electronic signature or a signature written in ink;

(d) details about the prescribed product, including where applicable the—

(i) common name of the product as defined by Article 1 of the 2001 Directive,

(ii) brand name if—

(aa) the prescribed product is a biological medicinal product, or

(bb) B deems it medically necessary for that product to be dispensed and B’s reasons justifying the use of the branded product,

(iii) pharmaceutical formulation (tablet, solution, etc.),

(iv) quantity,

(v) strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi) dosage regimen.

(4) A prescription under this regulation may only be issued by B in relation to those products that B is authorised to prescribe under regulation 214(3) to (5B).]

Textual Amendments

F9 Reg. 217A inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 6 and reg. 217A inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 6

Requirements for prescriptions: EEA health professionals U.K.

218.—(1) For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner who is an EEA health professional unless the following conditions are met.

[F10 (2) Condition A is that—

(a) the prescription is issued in a relevant European State except the United Kingdom; and

(b) the prescribing EEA health professional is legally entitled to issue a prescription of that kind in the country in which the prescription is issued.]

[F11 (3) Condition B is that the prescription is signed in ink by the prescribing EEA health professional.]

(4) Condition C is that the prescription is written in ink or otherwise so as to be indelible.

[F12 (5) Condition D is that the prescription contains—

(a) the patient’s—

(i) surname,

(ii) first names written out in full, and

(iii) date of birth;

(b) the issue date of the prescription;

(c) the prescribing EEA health professional’s—

(i) surname,

(ii) first names written out in full,

(iii) professional qualification,

(iv) direct contact details including—

(aa) email address, and

(bb) telephone or fax number with the appropriate international prefix,

(v) work address, and

(vi) name of the relevant member State in which that EEA health professional works; and

(d) details about the prescribed product, including where applicable the—

(i) common name of the product,

(ii) brand name if—

(aa) the prescribed product is a biological medicinal product, or

(bb) the prescribing EEA health professional deems it medically necessary for that product to be dispensed and the EEA health professional’s reasons justifying the use of the branded product,

(iii) pharmaceutical formulation (tablet, solution, etc.),

(iv) quantity,

(v) strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi) dosage regimen.]

(6) Condition E is that the prescription—

(a) is not dispensed after the end of the period of six months beginning with the date on which it is signed by the EEA health professional; or

(b) in the case of a repeatable prescription—

(i) it is not dispensed for the first time after the end of that period, and

(ii) it is dispensed in accordance with the directions contained in the prescription.

(7) Condition F is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a) it is not dispensed on more than two occasions; or

(b) in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the date on which it is signed by the EEA health professional.

(8) This regulation is subject to regulation [F13 219A (electronic prescriptions: EEA health professionals)].

Textual Amendments

F10 Reg. 218(2) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 23 and reg. 218(2) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 23

F11 Reg. 218(3) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(3) and reg. 218(3) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(3)

F12 Reg. 218(5) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(4) and reg. 218(5) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(4)

F13 Words in reg. 218(8) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 3 and words in reg. 218(8) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 3

Electronic prescriptions U.K.

219.—(1) This regulation applies to a prescription that is not a health prescription for a [F14 substance or product for the time being specified in Schedule 1 to the Misuse of Drugs Regulations 2001 or in Schedule 1 to the Misuse of Drugs Regulations (Northern Ireland) 2002].

(2) A prescription only medicine is also sold or supplied in accordance with a prescription given by an appropriate practitioner other than an EEA health professional if—

(a) conditions A and B in regulation 217 are not met; but

(b) the conditions in paragraph (4) of this regulation and conditions C to E in regulation 217 are met.

F15 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The conditions mentioned in [F16 paragraph (2)(b)] are that the prescription is—

(a) created in electronic form;

[F17 (b) signed with an advanced electronic signature; and

(c) sent to the person by whom it is dispensed—

(i) as an electronic communication (whether or not through one or more intermediaries), and

(ii) via the electronic prescription service, if it is for a substance or product for the time being specified in Schedule 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002.]

[F18 (5) In this regulation—

[F19 “advanced electronic signature” has the meaning given within Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market;]

“electronic prescription service” means the service of that name which is managed by the Health and Social Care Information Centre established under section 252 of the Health and Social Care Act 2012 (the Health and Social Care Information Centre).]

Textual Amendments

F14 Words in reg. 219(1) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(2) and words in reg. 219(1) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(2)

F15 Reg. 219(3) omitted (E.W.S.) (1.7.2015) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(3) and reg. 219(3) omitted (N.I.) (1.7.2015) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(3)

F16 Words in reg. 219(4) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(4)(a) and words in reg. 219(4) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(4)(a)

F17 Reg. 219(4)(b)(c) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(4)(b) and reg. 219(4)(b)(c) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(4)(b)

F18 Reg. 219(5) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(5) and reg. 219(5) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(5)

F19 Words in reg. 219(5) substituted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 8(2)

[F20 Electronic Prescriptions: EEA health professionals U.K.

219A.— (1) This regulation applies to a prescription that is not a health prescription for a product subject to special medical prescription.

(2) A prescription only medicine is also sold or supplied in accordance with a prescription given by an EEA health professional if—

(a) conditions B and C in regulation 218 are not met; but

(b) the conditions in paragraph (3) of this regulation and conditions A and D to F in regulation 218 are met.

(3) The conditions mentioned in paragraph (2)(b) are that the prescription is—

(a) created in electronic form;

(b) signed with an electronic signature; and

(c) sent to the person by whom it is dispensed as an electronic communication (whether or not through one or more intermediaries).]

Textual Amendments

F20 Reg. 219A inserted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 5 and reg. 219A inserted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 5

Medicines not subject to general sale U.K.

Sale or supply of medicinal products not subject to general sale U.K.

220.—(1) Unless paragraph (2) applies, a person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is not subject to general sale.

(2) This paragraph applies if—

(a) P is a person lawfully conducting a retail pharmacy business;

(b) the product is sold, supplied, or offered for sale or supply, on premises that are a registered pharmacy; and

(c) P or, if the transaction is carried out on P's behalf by another person, that other person is, or acts under the supervision of, a pharmacist.

(3) This regulation is subject to Chapter 3.

General sale medicines U.K.

Sale or supply of medicinal products subject to general sale U.K.

221.—(1) A person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is subject to general sale elsewhere than at a registered pharmacy unless the following conditions are met.

(2) Condition A is that the place at which the medicinal product is sold, supplied, or offered for sale or supply, consists of premises of which P is the occupier and which P is able to close so as to exclude the public.

(3) Condition B is that—

(a) the medicinal product was made up for sale in its immediate and outer packaging elsewhere than at the place at which it is sold, supplied, or offered for sale or supply; and

(b) the immediate and outer packaging has not been opened since the product was made up for sale in it.

(4) Condition C is that, if the medicinal product is of a kind specified in Schedule 15, it is presented for sale in accordance with the requirements specified in that Schedule for a product of that kind.

(5) This regulation is subject to Chapter 3.

Sale of medicinal products from automatic machines U.K.

222.  A person may not sell or offer for sale a medicinal product by means of an automatic machine if the product is not subject to general sale.