The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016

PART 2 U.K. Amendments to the Medicines Act 1968

Amendment of section 74 of the 1968 Act U.K.

5.—(1) Section 74 of the 1968 Act(1) (meaning of “registered pharmacy”) is amended as follows.

(2) In subsection (1A)—

(a) for “paragraph (4)(b) of article 14” substitute “section 82A of this Act(2), paragraph 8 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976(3) or article 14(4)(b) or 56(4)”;

(b) omit “of that Order”; and

(c) after “by rules” insert “in relation to Great Britain or the Council of the Pharmaceutical Society of Northern Ireland may prescribe by regulations in relation to Northern Ireland”.

(3) In subsection (1B), for “apart from that Order” substitute “except for a purpose prescribed by the rules or regulations mentioned in subsection (1A)”.

Commencement Information

I1 Art. 5 not in force at made date, see art. 1(3)

I2 Art. 5 in force at 24.5.2018 for E.W.S. by S.I. 2018/512, art. 2(1)(a)(i)(2)

Amendment of section 74B of the 1968 Act U.K.

6.  In section 74B of the 1968 Act(5) (conditions for registration: Great Britain), in subsection (5)—

(a) in paragraph (a), for “provided for in rules made” substitute “set”; and

(b) in paragraph (b)—

(i) in sub-paragraph (i), for “provided for in rules made” substitute “set”, and

(ii) in sub-paragraph (ii), after “of rules” insert “(if any)”.

Commencement Information

I3 Art. 6 not in force at made date, see art. 1(3)

I4 Art. 6 in force at 24.5.2018 for E.W.S. by S.I. 2018/512, art. 2(1)(a)(i)(2)

Amendment of section 74H of the 1968 Act U.K.

7.  In section 74H of the 1968 Act(6) (change of ownership of retail pharmacy business: Great Britain), in subsection (6)(c), for “provided for in rules made” substitute “set”.

Commencement Information

I5 Art. 7 not in force at made date, see art. 1(3)

I6 Art. 7 in force at 24.5.2018 for E.W.S. by S.I. 2018/512, art. 2(1)(a)(i)(2)

Prospective

Amendment of section 75 of the 1968 Act U.K.

8.  In section 75 of the 1968 Act(7) (registration of premises: Northern Ireland), omit subsections (4) to (6).

Commencement Information

I7 Art. 8 not in force at made date, see art. 1(3)

Amendment of section 80 of the 1968 Act U.K.

9.—(1) Section 80 of the 1968 Act(8) (power for relevant disciplinary committee to disqualify and direct removal from register) is amended as follows.

(2) In subsection (1)(c)—

(a) omit “in Great Britain”;

(b) after “premises at” insert “or from”;

(c) for “provided for in rules made under” substitute “set under Article 5A(1) of the Pharmacy (Northern Ireland) Order 1976(9) or”; and

(d) after “business at” insert “or from”.

(3) After subsection (1), insert the following subsections—

“(1A) Where—

(a) a pharmacist or partnership carries on a retail pharmacy business, and

(b) in respect of premises that are entered in the register as premises at or from which that pharmacist or partnership carries on that business, there is a failure to meet the standards that are set under Article 5A(1) of the Pharmacy (Northern Ireland) Order 1976 or article 7(1) of the Pharmacy Order 2010(10) in connection with the carrying on of the business at or from those premises,

then, subject to the following provisions of this Part of this Act, the relevant disciplinary committee, after inquiring into the case, may direct that the pharmacist or partnership is to be disqualified for the purposes of this Part of this Act.

(1B) But, in a case falling within subsection (1)(c) or (1A), the relevant disciplinary committee may only give a direction under the subsection in question if they are satisfied that the body corporate, the pharmacist or the partnership is unfit to carry on a retail pharmacy business safely and effectively, so far as concerns—

(a) the retail sale of medicinal products (whether they are on a general sale list or not), or

(b) the supply of such products in circumstances corresponding to retail sale.”.

(4) In subsection (2)—

(a) for “within the preceding subsection” substitute “within subsection (1) or (1A)”;

(b) in paragraph (a)—

(i) for “that subsection” substitute “the subsection in question”,

(ii) after “premises at” insert “or from”, and

(iii) after “body corporate” insert “, the pharmacist or the partnership”; and

(c) in paragraph (b), for “the preceding subsection” substitute “the subsection in question”.

(5) After subsection (2), insert the following subsection—

“(2A) But, in a case falling within subsection (1)(c) or (1A), the relevant disciplinary committee may only direct the registrar under subsection (2)(b) to remove premises from the register if they are satisfied that the body corporate, the pharmacist or the partnership is unfit to carry on a retail pharmacy business safely and effectively at or from those premises, so far as concerns—

(a) the retail sale of medicinal products (whether they are on a general sale list or not), or

(b) the supply of such products in circumstances corresponding to retail sale.”.

(6) In subsection (3)—

(a) after “subsection (1)” insert “or (1A)”; and

(b) for “the last preceding subsection”, at each place where it occurs, substitute “subsection (2)”.

Commencement Information

I8 Art. 9 not in force at made date, see art. 1(3)

I9 Art. 9 in force at 24.5.2018 for E.W.S. by S.I. 2018/512, art. 2(1)(a)(ii)(2)

Amendment of section 82 of the 1968 Act U.K.

10.  In section 82 of the 1968 Act(11) (procedure relating to disqualification)—

(a) in subsection (2), after “body corporate” insert “, pharmacist, partnership”; and

(b) in subsection (3), after “body corporate” insert “, pharmacist, partnership”.

Commencement Information

I10 Art. 10 not in force at made date, see art. 1(3)

I11 Art. 10 in force at 24.5.2018 for E.W.S. by S.I. 2018/512, art. 2(1)(a)(ii)(2)

New section 82A of the 1968 Act U.K.

11.  After section 82 of the 1968 Act (procedure relating to disqualification), insert the following section—

“Interim measures

82A.— (1) Subsection (2) applies where—

(a) the relevant disciplinary committee have given a direction (“the principal direction”) under section 80(1), (1A) or (2) in relation to a body corporate, pharmacist or partnership; and

(b) the direction has not yet taken effect.

(2) Where the committee are satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest, the committee may direct the registrar to suspend from the register, until the principal direction takes effect or an appeal under section 82(3) against the principal direction is successful—

(a) all entries of premises entered in the register as premises at or from which the body corporate, pharmacist or partnership carries on a retail pharmacy business; or

(b) entries of such of those premises as may be specified in the direction under this subsection.

(3) Where the committee give a direction under subsection (2), the registrar must send to the body corporate, pharmacist or partnership to whom the direction relates a statement in writing giving that person notice of—

(a) the contents of the direction; and

(b) the right of appeal under subsection (5).

(4) The statement must be sent—

(a) in the case of a body corporate, to the body corporate at its registered or principal office;

(b) in the case of a pharmacist, to the pharmacist at the pharmacist’s home address in the register;

(c) in the case of a partnership, to the partnership at its principal office.

(5) A body corporate, pharmacist or partnership to whom a direction under subsection (2) relates may appeal against the direction to the High Court.

(6) Subsections (4) to (6) of section 82 apply in relation to an appeal under subsection (5) as they apply in relation to an appeal under section 82(3).

(7) Subsections (7) and (8) of section 82 apply in the application of this section to Scotland or Northern Ireland as they apply in the application of section 82 to Scotland or Northern Ireland.”.

Commencement Information

I12 Art. 11 not in force at made date, see art. 1(3)

I13 Art. 11 in force at 24.5.2018 for E.W.S. by S.I. 2018/512, art. 2(1)(a)(ii)(2)

Prospective

New section 84B of the 1968 Act U.K.

12.  After section 84A of the 1968 Act(12) (rules by the General Pharmaceutical Council), insert the following section—

“Regulations by the Council of the Pharmaceutical Society of Northern Ireland

84B.   The provisions of Article 25A of the Pharmacy (Northern Ireland) Order 1976(13) apply to the making of regulations by the Council of the Pharmaceutical Society of Northern Ireland under this Part as they apply to the making of regulations by that Council under that Order.”.

Commencement Information

I14 Art. 12 not in force at made date, see art. 1(3)

(1)

Section 74 has been amended by the Statute Law (Repeals) Act 1993 (c. 50), Schedule 1(12), paragraph 1, and by S.I. 2010/231.

(2)

Section 82A is inserted by article 11 of this Order.

(3)

Schedule 3 was substituted by S.R. 2012/308.

(4)

Articles 14 and 56 are amended by articles 23 and 25 of this Order respectively.

(5)

Section 74B was inserted by S.I. 2010/231.

(6)

Section 74B was inserted by S.I. 2010/231.

(7)

Section 75 has been amended by S.I. 2010/231.

(8)

Section 80 has been amended by S.I. 2007/289 and 2010/231.

(9)

Paragraph 5A is inserted by article 13 of this Order.

(10)

Article 7(1) is substituted by article 19(2) of this Order.

(11)

Amended by the Constitutional Reform Act 2005 (c. 4), Schedule 11, paragraph 6(1), and by S.I. 2007/289 and 2012/1916.

(12)

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

(13)

Article 25A was inserted by S.R. 2012/308.