Regulation 20 Mixing of medicines

United Kingdom

(1)

Regulation 17(1) (manufacturing of medicinal products) does not apply to the mixing of medicines by—

(a)

a nurse independent prescriber;

(b)

a pharmacist independent prescriber;

(c)

a supplementary prescriber, if the mixing of medicines forms part of the clinical management plan for an individual patient;

F1(ca)

physiotherapist independent prescriber;

(cb)

podiatrist independent prescriber;

F2(cc)

a therapeutic radiographer independent prescriber;

F3(cd)

a paramedic independent prescriber;

(d)

a person acting in accordance with the written directions of a—

(i)

doctor,

(ii)

dentist,

(iii)

nurse independent prescriber, F4...

F5(iv)

pharmacist independent prescriber,

(v)

physiotherapist independent prescriber, F6...

(vi)

podiatrist independent prescriber; or

F7(vii)

therapeutic radiographer independent prescriber; or

F8(viii)

paramedic independent prescriber; or

(e)

a person acting in accordance with the written directions of a supplementary prescriber, if the mixing of medicines forms part of the clinical management plan for an individual patient.

(2)

In this regulation “mixing of medicines” means F9the combining together of two or more medicinal products, none of which are MM medicinal products nor POC medicinal products for the purposes of administering them to meet the needs of an individual patient.

Annotations

Textual amendments

F1: Reg. 20(1)(ca)(cb) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(a)
F2: Reg. 20(1)(cc) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(a) and reg. 20(1)(cc) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(a)
F3: Reg. 20(1)(cd) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 4(2)(a) and reg. 20(1)(cd) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 4(2)(a)
F4: Word in reg. 20(1)(d)(iii) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(b)
F5: Reg. 20(1)(d)(iv)-(vi) substituted for reg. 20(1)(d)(iv) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(c)
F6: Word in reg. 20(1)(d)(v) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(b)(i) and word in reg. 20(1)(d)(v) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(b)(i)
F7: Reg. 20(1)(d)(vii) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(b)(ii) and reg. 20(1)(d)(vii) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(b)(ii)
F8: Reg. 20(1)(d)(viii) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 4(2)(b) and reg. 20(1)(d)(viii) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 4(2)(b)
F9: Words in reg. 20(2) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 7

Notes on Part 3

Textual amendments

F1: Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

Notes on Chapter 2

Textual amendments

F1: Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4