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SCHEDULES

Article 9

SCHEDULE 1U.K.AMENDMENTS CONSEQUENTIAL ON ARTICLES 5 AND 6

Medicines Act 1968U.K.

1.  The 1968 Act is amended in accordance with paragraphs 2 to 8.

Commencement Information

I1Sch. 1 para. 1 not in force at made date, see art. 1(3)

I2Sch. 1 para. 1 in force at 1.12.2022 by S.I. 2022/1023, art. 2

2.  For the title to section 72B(1) substitute “Sections 72A and 72AA: supplementary”.

Commencement Information

I3Sch. 1 para. 2 not in force at made date, see art. 1(3)

I4Sch. 1 para. 2 in force at 1.12.2022 by S.I. 2022/1023, art. 2

3.  In section 72B—

(a)in subsection (1), for the words from “section 72A” to “under that section,” substitute “section 72A or 72AA of this Act, or of rules or regulations made under section 72A,”;

(b)omit subsection (2); and

(c)in subsection (3)—

(i)in paragraph (a), before “regulations made” insert “rules or”, and

(ii)in paragraph (b), before “regulations made” insert “rules or”, and for “subsection (7)(b)” substitute “subsection (7)”.

Commencement Information

I5Sch. 1 para. 3 not in force at made date, see art. 1(3)

I6Sch. 1 para. 3 in force at 1.12.2022 by S.I. 2022/1023, art. 2

4.  In section 84(2) (offences under Part 4), omit subsection (A1).

Commencement Information

I7Sch. 1 para. 4 not in force at made date, see art. 1(3)

I8Sch. 1 para. 4 in force at 1.12.2022 by S.I. 2022/1023, art. 2

5.  In section 84A(3) (rules by the General Pharmaceutical Council)—

(a)in subsection (2), for “Part 4 of this Act” substitute “any provision of Part 4 of this Act other than section 72A”; and

(b)after subsection (2), insert the following subsections—

(3) The power of the General Pharmaceutical Council to make rules under section 72A may be exercised so as to make different provision for different areas or in relation to different cases or different circumstances to which the power is applicable, and to make any such provision subject to such exceptions, limitations and conditions (if any) as the General Pharmaceutical Council considers necessary or expedient.

(4) Before making rules under section 72A, the General Pharmaceutical Council must publish draft rules and invite representations to be made to it about the draft by—

(a)the Secretary of State, the Scottish Ministers and the Welsh Ministers, and

(b)any other persons appearing to it appropriate to consult about the draft.

(5) No rules made under section 72A by the General Pharmaceutical Council are to come into force until approved by order of the Privy Council.

(6) The power vested in the Privy Council to make an order under subsection (5) may be exercised by any two or more members of the Privy Council.

(7) The making of an order under subsection (5) is sufficiently signified by an instrument signed by the Clerk of the Privy Council.

(8) Where an order under subsection (5) is signified by an instrument purporting to be signed by the Clerk of the Privy Council, that is evidence and in Scotland sufficient evidence of—

(a)the fact that the order was duly made, and

(b)the order’s terms..

Commencement Information

I9Sch. 1 para. 5 not in force at made date, see art. 1(3)

I10Sch. 1 para. 5 in force at 1.12.2022 by S.I. 2022/1023, art. 2

6.  In section 108(4) (enforcement in England and Wales)—

(a)omit subsection (6A);

(b)in subsection (6B), for “the other provisions of section 72A of this Act, and any regulations made under them,” substitute “the provisions of sections 72A and 72AA of this Act, and any rules made under section 72A,”;

(c)in subsection (6C), for “those other provisions, or any regulations made under them,”, substitute “those provisions, or any rules made under section 72A,”;

(d)in subsection (6D)—

(i)in paragraph (a), for “those other provisions, or any regulations made under them,” substitute “those provisions, or any rules made under section 72A,”, and

(ii)in paragraph (b), for “those other provisions or those regulations” substitute “those provisions or those rules”; and

(e)in subsection (10), for the words from “subsections (6A) or (6B)” to the end of that subsection substitute “subsection (6B) to enforce any provisions or rules mentioned in that subsection, and that the public interest requires that the provisions or rules in question should be enforced in relation to it, the appropriate Minister may enforce those provisions or rules in relation to that matter.”.

Commencement Information

I11Sch. 1 para. 6 not in force at made date, see art. 1(3)

I12Sch. 1 para. 6 in force at 1.12.2022 by S.I. 2022/1023, art. 2

7.  In section 110(5) (enforcement in Northern Ireland)—

(a)omit subsection (3A);

(b)in subsection (3B), for “the other provisions of section 72A of this Act, and any regulations made under them,” substitute “the provisions of sections 72A and 72AA of this Act, and any regulations made under section 72A,”;

(c)in subsection (3C), for “those other provisions, or any regulations made under them,”, substitute “those provisions, or any regulations made under section 72A,”; and

(d)in subsection (3D)—

(i)in paragraph (a), for “those other provisions, or any regulations made under them,” substitute “those provisions, or any regulations made under section 72A,”, and

(ii)in paragraph (b), omit “other”.

Commencement Information

I13Sch. 1 para. 7 not in force at made date, see art. 1(3)

I14Sch. 1 para. 7 in force at 1.12.2022 by S.I. 2022/1023, art. 2

8.  In section 129(6) (orders and regulations)—

(a)in subsection (2), before “paragraph 1” insert “section 72A of this Act or”; and

(b)in subsection (3)(a), after “79” insert “, 84A(5)”.

Commencement Information

I15Sch. 1 para. 8 not in force at made date, see art. 1(3)

I16Sch. 1 para. 8 in force at 1.12.2022 by S.I. 2022/1023, art. 2

Pharmacy (Northern Ireland) Order 1976U.K.

9.  In Article 25A of the Pharmacy (Northern Ireland) Order 1976(7) (regulations: procedure), at the end insert—

(3) Before making regulations under section 72A of the Medicines Act 1968 the Council must publish draft regulations and invite representations to be made to it about the draft by—

(a)the Department; and

(b)any other persons appearing to it appropriate to consult about the draft..

Commencement Information

I17Sch. 1 para. 9 not in force at made date, see art. 1(3)

I18Sch. 1 para. 9 in force at 1.12.2022 by S.I. 2022/1023, art. 2

Health Act 2006U.K.

10.  In the Health Act 2006(8), omit section 30(3) (the responsible pharmacist).

Commencement Information

I19Sch. 1 para. 10 not in force at made date, see art. 1(3)

I20Sch. 1 para. 10 in force at 1.12.2022 by S.I. 2022/1023, art. 2

Pharmacy Order 2010U.K.

11.  Paragraph 66 of Schedule 4 to the Pharmacy Order 2010(9) (amendments, repeals and revocations – amendment of the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008) is revoked.

Commencement Information

I21Sch. 1 para. 11 not in force at made date, see art. 1(3)

I22Sch. 1 para. 11 in force at 1.12.2022 by S.I. 2022/1023, art. 2

(1)

Section 72B was inserted by the Health Act 2006, section 30(1), and then amended by S.I. 2010/231.

(2)

Subsection (A1) was inserted into section 84 by the Health Act 2006 (c. 28), section 30(3).

(3)

Section 84A was inserted by S.I. 2010/231.

(4)

Section 108 was amended by the Food Safety Act 1990 (c. 16), Schedule 3, paragraph 8, and the Health Act 2006 (c. 28), section 31(1), and by S.I. 1968/1699, 2006/2407, 2010/231 and 2012/1916.

(5)

Section 110 was amended by the Health Act 2006 (c. 28), section 31(3), by S.R. (N.I.) 1973/211, and by S.I. 2006/2407 and 2012/1916.

(6)

Section 129 was amended by the the Food Standards Act 1999 (c. 28), Schedule 3, paragraph 15, the Health Act 2006 (c. 28), section 32, and by S.I. 2006/2407 and 2012/1916.