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The Human Medicines Regulations 2012
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- UK Statutory Instruments
- 2012 No. 1916
- SCHEDULE 23
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The Human Medicines Regulations 2012, SCHEDULE 23 is up to date with all changes known to be in force on or before 16 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.
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Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):
- Sch. 11 para. 1(1)(d)-(f) inserted by S.I. 2019/775 reg. 63(2)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 63(2)(a)(ii) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(2))
- Sch. 24 para. 18B inserted by S.I. 2024/832 reg. 142(e)
- Sch. 24 Pt. 1 para. 23 words omitted by S.I. 2024/832 reg. 142(f)
- Sch. 33A para. 57A inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(4) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
- Sch. 33A para. 57(3) substituted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
- Sch. 33A para. 57(2) words inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
- Sch. 33B inserted by S.I. 2024/832 reg. 146
- reg. 3(12)(d)(ia) omitted by S.I. 2024/832 reg. 4(a)
- reg. 4(4)(d)(ia) omitted by S.I. 2024/832 reg. 5
- reg. 43(7)(b)(ii)(bb) words omitted by S.I. 2024/832 reg. 18(b)
- reg. 49(1ZA)-(1ZD) inserted by S.I. 2024/832 reg. 26(a)
- reg. 49(3ZA) inserted by S.I. 2024/832 reg. 26(d)
- reg. 51(9) words inserted by S.I. 2019/775, reg. 56 (as amended) by S.I. 2019/1385 Sch. 1 para. 5 (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
- reg. 52(1)(a)(i)(ii) and words substituted by S.I. 2019/775 reg. 57(2) (This amendment not applied to legislation.gov.uk. Reg. 57 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 42)
- reg. 53(2)-(2C) substituted for reg. 53(2) by S.I. 2019/775 reg. 58(3) (This amendment not applied to legislation.gov.uk. Reg. 58 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 43)
- reg. 53(2)(a) substituted by S.I. 2019/775, reg. 58(3) (as amended) by S.I. 2019/1385 Sch. 1 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
- reg. 55(1)(b)(iii)(bb) substituted by S.I. 2024/832 reg. 43(a)(ii)
- reg. 60A(10A) inserted by S.I. 2024/832 reg. 49(e)
- reg. 68(11H)-(A12) inserted by S.I. 2024/832 reg. 56(b)
- reg. 173(e) inserted by S.I. 2017/1322 Sch. 4 para. 2(2)(b) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(i).)
- reg. 233(1)(a)(ivd) substituted by S.I. 2024/1125 reg. 6
- reg. 237A inserted by S.I. 2024/1125 reg. 7
- reg. 240(2A) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(c) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 240(6A) inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(g) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 250(4B) inserted by S.I. 2024/1125 reg. 8
- reg. 257(9) inserted by S.I. 2024/832 reg. 110(c)
- reg. 257AA 257AB inserted by S.I. 2024/832 reg. 111
- reg. 327(1)(c)(va) omitted by S.I. 2024/832 reg. 128(a)
- reg. 346(2)(c)(iia) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(iiia) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(iva) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(xviia) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(xxviiij) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(d)(iva) words omitted by S.I. 2024/1125 reg. 9(b)
- reg. 346(2)(d)(ivza) words substituted by S.I. 2024/1125 reg. 9(a)
- reg. 346(2)(d)(ivb) words substituted by S.I. 2024/1125 reg. 9(c)
- reg. 347B inserted by S.I. 2024/832 reg. 133
Regulation 253
SCHEDULE 23U.K.Particulars in pharmacy records
This schedule has no associated Explanatory Memorandum
1. Paragraph 2 applies, subject to paragraph 3, where the sale or supply of a prescription only medicine is—U.K.
(a)in pursuance of a prescription given by—
(i)a doctor or dentist,
(ii)a supplementary prescriber,
(iii)a community practitioner nurse prescriber,
(iv)a nurse independent prescriber,
[F1(v)an optometrist independent prescriber,
(vi)a pharmacist independent prescriber,
(vii)a podiatrist independent prescriber,
(viii)a physiotherapist independent prescriber, F2...
(ix)a therapeutic radiographer independent prescriber; or]
[F3(x)a paramedic paramedic independent prescriber; or]
(b)under regulation 224 (emergency sale etc by pharmacist: prescriber unable to provide prescription).
Textual Amendments
F1Sch. 23 para. 1(a)(v)-(ix) substituted for Sch. 23 para. 1(a)(v)(vi) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 17 and Sch. 23 para. 1(a)(v)-(ix) substituted for Sch. 23 para. 1(a)(v)(vi) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 17
F2Word in Sch. 23 para. 1(a)(viii) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 13(2)(a) and word in Sch. 23 para. 1(a)(viii) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 13(2)(a)
F3Sch. 23 para. 1(a)(x) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 13(2)(b) and Sch. 23 para. 1(a)(x) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 13(2)(b)
2. In such a case, the particulars referred to in regulation 253(2)(a) are—U.K.
(a)the date on which the prescription only medicine was sold or supplied;
(b)the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;
(c)the name and address of the person giving the prescription;
(d)the name and address of the person for whom the prescription only medicine was prescribed;
(e)the date on the prescription; and
(f)in relation to the sale or supply of a prescription only medicine under regulation 224 the date on which the prescription relating to that sale or supply is received.
3. Where the sale or supply is in pursuance of a repeatable prescription and is not the first sale or supply in pursuance of that prescription, the particulars referred to in regulation 253(2)(a) are either—U.K.
(a)the date on which the prescription only medicine is sold or supplied and a reference to the entry in the record referred to in regulation 253(1) which was made in respect of the first sale or supply in pursuance of that prescription and which contains the particulars specified in paragraph 2; or
(b)the particulars specified in paragraph 2.
4. Where the sale or supply of a prescription only medicine is a sale or supply under regulation 225 (emergency sale etc by pharmacist: at patient's request), the particulars referred to in regulation 253(2)(a) are—U.K.
(a)the date on which the prescription only medicine was sold or supplied;
(b)the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;
(c)the name and address of the person requiring the prescription only medicine; and
(d)the nature of the emergency.
5. Paragraph 6 applies where—U.K.
(a)the sale or supply of a prescription only medicine is by way of wholesale dealing and no order or invoice or copy of the order or invoice has been retained under regulation 224 or 225; or
(b)the sale or supply is one to which regulation 214(1) does not apply by reason of an exemption other than that in regulation 224 or 225.
6. In such a case, the particulars referred to in regulation 253(2)(a) are—U.K.
(a)the date on which the prescription only medicine is sold or supplied;
(b)the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;
(c)the name and address and trade, business or profession of the person to whom the prescription only medicine is sold or supplied; and
(d)the purpose for which the prescription only medicine is sold or supplied.
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