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 [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)

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 [F11 approved country health professional]) in relation to the prescription only medicine in question.

Textual Amendments

F11 Words in reg. 216(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 181; 2020 c. 1, Sch. 5 para. 1(1)

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 [F12 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 [F13 approved country health professional] (as to which see regulation 218); and

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

Textual Amendments

F12 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)

F13 Words in reg. 217(8)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 182; 2020 c. 1, Sch. 5 para. 1(1)

[F14 Requirements for prescriptions to be dispensed in an EEA state F15 ... 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 F16 ...; 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

F14 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

F15 Words in reg. 217A heading omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 183(2); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in reg. 217A(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 183(3); 2020 c. 1, Sch. 5 para. 1(1)

[F17 Original pack dispensing E+W+S

217B.— (1) Subject to paragraphs (2) to (4) and regulation 217C, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

(a) a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

(b) the sale or supply is otherwise in accordance with the prescription.

(2) Paragraph (1) does not apply—

(a) to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

(b) in circumstances where a pharmacist is carrying out or supervising the sale or supply and the pharmacist considers, in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

(3)  Paragraph (2) does not apply to—

(a) a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

(b) a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

(c) a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine.

(4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to—

(a) in England, paragraph 8(1)(b) of Schedule 4, or paragraph 6(1)(b) of Schedule 7, to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013,

(b) in Wales, paragraph 9(1)(b) of Schedule 5 to the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.

Textual Amendments

F17 Regs. 217B, 217C inserted (E.W.S.) (11.10.2023) by The Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023 (S.I. 2023/1015), regs. 1(2), 2(2)

[F18 Original pack dispensing: Northern Ireland NI

217BA.— (1) Subject to paragraphs (2) to (4) and regulation 217CA, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

(a) a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

(b) the sale or supply is otherwise in accordance with the prescription.

(2) Paragraph (1) does not apply—

(a) to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

(b) in circumstances where a pharmacist is carrying out or supervising the sale or supply and the pharmacist considers, in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

(3) Paragraph (2) does not apply to—

(a) a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

(b) a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

(c) a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine.

(4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to paragraphs 2(1) and (1A) of Schedule 2 to the Pharmaceutical Services Regulations (Northern Ireland) 1997,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.]

Textual Amendments

F17 Regs. 217B, 217C inserted (E.W.S.) (11.10.2023) by The Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023 (S.I. 2023/1015), regs. 1(2), 2(2)

F18 Reg. 217BA inserted (N.I.) (4.6.2024) by The Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024 (S.R. 2024/125), regs. 1(2), 2(2)

Original pack dispensing: medicinal products containing a relevant substance E+W+S

217C.— (1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

(a) it is sold or supplied in its manufacturer’s original outer packaging; and

(b) if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

(2) Paragraph (1) does not apply where—

(a) the sale or supply is by or under the supervision of a pharmacist; and

(b) the pharmacist is satisfied that—

(i) a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

(ii) unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

(3) In this regulation, “relevant substance” means any of the following—

(a) sodium valproate;

(b) valproic acid;

(c) valproate semisodium.]

Textual Amendments

F17 Regs. 217B, 217C inserted (E.W.S.) (11.10.2023) by The Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023 (S.I. 2023/1015), regs. 1(2), 2(2)

[F19 Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland NI

217CA.— (1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

(a) it is sold or supplied in its manufacturer’s original outer packaging; and

(b) if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

(2) Paragraph (1) does not apply where—

(a) the sale or supply is by or under the supervision of a pharmacist; and

(b) the pharmacist is satisfied that—

(i) a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

(ii) unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

(3) In this regulation, “relevant substance” means any of the following—

(a) sodium valproate;

(b) valproic acid;

(c) valproate semisodium.]

Textual Amendments

F19 Reg. 217CA inserted (N.I.) (4.6.2024) by The Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024 (S.R. 2024/125), regs. 1(2), 2(3)

Requirements for prescriptions: [F20 approved country health professional] 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 [F21 approved country health professional] unless the following conditions are met.

[F22 (2) Condition A is that—

(a) the prescription is issued in a [F23 country included in the list published under regulation 214(6A)]; and

(b) the prescribing [F21 approved country health professional] is legally entitled to issue a prescription of that kind in the country in which the prescription is issued.]

[F24 (3) Condition B is that the prescription is signed in ink by the prescribing [F21 approved country health professional].]

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

[F25 (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 [F26 approved country 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 [F21 approved country 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 [F21 approved country health professional] deems it medically necessary for that product to be dispensed and the [F27 approved country 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 [F21 approved country 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 [F21 approved country health professional].

(8) This regulation is subject to regulation [F28 219A (electronic prescriptions: EEA health professionals)].

Textual Amendments

F20 Words in reg. 218 heading substituted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(2); 2020 c. 1, Sch. 5 para. 1(1)

F21 Words in reg. 218 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(2); 2020 c. 1, Sch. 5 para. 1(1)

F22 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

F23 Words in reg. 218(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(4); 2020 c. 1, Sch. 5 para. 1(1)

F24 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)

F25 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)

F26 Words in reg. 218(5)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(3); 2020 c. 1, Sch. 5 para. 1(1)

F27 Words in reg. 218(5)(d)(ii)(bb) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(3); 2020 c. 1, Sch. 5 para. 1(1)

F28 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 [F29 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 [F30 approved country 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.

F31 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The conditions mentioned in [F32 paragraph (2)(b)] are that the prescription is—

(a) created in electronic form;

[F33 (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.]

[F34 (5) In this regulation—

[F35 “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 [F36 NHS England, the body corporate established under section 1H of the National Health Service Act 2006.]]

Textual Amendments

F29 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)

F30 Words in reg. 219(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 185; 2020 c. 1, Sch. 5 para. 1(1)

F31 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)

F32 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)

F33 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)

F34 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)

F35 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)

F36 Words in reg. 219(5) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 44 (with reg. 3)

[F37 Electronic Prescriptions: [F38 approved country 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 [F39 approved country 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

F37 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

F38 Words in reg. 219A heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 186(2); 2020 c. 1, Sch. 5 para. 1(1)

F39 Words in reg. 219A(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 186(3); 2020 c. 1, Sch. 5 para. 1(1)

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.