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The Human Medicines Regulations 2012

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The Human Medicines Regulations 2012, Paragraph 5 is up to date with all changes known to be in force on or before 19 March 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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  • 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. 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))
  • 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. 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. 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. 247A(7) inserted by S.I. 2024/344 reg. 5(4)
This section has no associated Explanatory Memorandum

5.  In section 58 M1 (medicinal products on prescription only)—U.K.

(a)in subsection (1) for the words from the first occurrence of “for the purposes” to the end of the subsection substitute “ as prescription only medicines ”;

(b)omit subsections (1A), (2) and (3);

(c)in the opening words of subsection (4) for “the last preceding subsection” substitute “ regulation 223(1) of the 2012 Regulations ”;

(d)in subsection (4)(a)—

(i)for “paragraph (a) or paragraph (b) of subsection (2) of this section, or both those paragraphs,” substitute “ regulation 214(1) or (2) of the 2012 Regulations ”, and

(ii)for the words from “or, where” to “of this section” substitute “ or, in the case of an appropriate practitioner, other than a doctor or dentist, ”;

(e)in subsection (4)(b) for “paragraph (a) of that subsection” substitute “ regulation 214(1) of the 2012 Regulations ”;

(f)in subsection (4A) for “a person who is an appropriate practitioner by virtue of subsection (1)(d) or (e)” substitute “ an appropriate practitioner, other than a doctor or dentist ”;

(g)in subsection (4C) for “subsection (2)(a) or (b) of this section” substitute “ regulation 214(1) or (2) of the 2012 Regulations ”; and

(h)after subsection (6) insert—

(7) In subsection (6) “the appropriate committee” means whichever the Ministers consider appropriate of—

(a)the Commission; or

(b)an expert committee appointed by the Ministers, or by one of them acting alone..

Marginal Citations

M1Section 58((1), (4) and (6) was amended by paragraph 29 of Part 1 of Schedule 8 to S.I. 2006/2407. Section 58(4) was amended by paragraph 2(b) of Schedule 5 to S.I. 2002/53. Section 58(4) was amended by section 63(1 and (4) of, and section 58(4A) and (4C) inserted by section 63(1) and (5) of, the Health and Social Care Act 2001.

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