Medicines Act 1968

Part IVU.K. Pharmacies

Persons lawfully conducting retail pharmacy businessU.K.

69 General provisions.U.K.

(1)Subject to the provisions of any order made under section 73 of this Act, a person carrying on a retail pharmacy business shall be taken to be a person lawfully conducting such a business if, not being disqualified by virtue of section 80 of this Act,—

(a)that person (or, if the business is carried on by a partnership, each, or, in Scotland, one or more, of the partners) is a pharmacist and the conditions specified in section 70 of this Act are fulfilled in relation to the business, or

(b)that person is a body corporate and the conditions specified in section 71 of this Act are fulfilled in relation to the business, or

(c)that person is a representative of a pharmacist (as defined by section 72 of this Act) and the conditions specified in subsection (2) of that section are fulfilled in relation to him and in relation to the business and the period applicable in accordance with subsection (3) of that section has not expired.

F1(1ZA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F2(2)For the purposes of the application of this Part of this Act to a business which—

(a)is or is to be carried on in one or more separate or distinct parts (but not the whole) of a building, whether it is or is to be also carried on elsewhere or not, or

(b)so far as concerns the retail sale of medicinal products, or the supply of such products in circumstances corresponding to retail sale, is or is to be carried on in one or more separate or distinct parts (but not the whole) of a building, whether it is or is to be carried on elsewhere or not,

each such part of that building shall be taken to be separate premises.

(3)In this Part of this Act—

• F3...

• “the board”, in relation to a body corporate, means the body of persons controlling the body corporate, by whatever name called;

• F4...

• [F5“the register” means—

  (a)

  in relation to Great Britain, the register established and maintained under article 19 of the Pharmacy Order 2010; and

  (b)

  in relation to Northern Ireland, the register kept for the purposes of section 75;]

• [F6“the registrar” means—

  (a)

  in relation to Great Britain, the person appointed under article 18 of the Pharmacy Order 2010 as registrar for the purposes of that Order; and

  (b)

  in relation to Northern Ireland, the person appointed under Article 9(1) of the Pharmacy (Northern Ireland) Order 1976 as registrar for the purposes of that Order;]

• [F7“the relevant disciplinary committee” means—

  (a)

  in relation to Great Britain, the Fitness to Practise Committee established under article 4(6) of the Pharmacy Order 2010; and

  (b)

  in relation to Northern Ireland, the Statutory Committee appointed under Article 19 of the Pharmacy (Northern Ireland) Order 1976;]

• “ relevant European State ” means either an EEA State other than the United Kingdom or Switzerland.

• F8...]

[F9 70 Business carried on by individual pharmacist or by partners.U.K.

(1)The conditions referred to in section 69(1)(a) of this Act are that subsections (2) and (3) of this section are both satisfied as respects each of the premises [F10at or from which] the retail pharmacy business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2)This subsection is satisfied if a responsible pharmacist who satisfies [F11the requirement of subsection (4)] of this section is in charge of [F12the business carried on at or from] those premises, so far as concerns—

(a)the retail sale at [F13or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F14or from] those premises of such products in circumstances corresponding to retail sale.

(3)This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

(a)the name of the responsible pharmacist for the time being,

[F15(b)the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and]

(c)the fact that he is for the time being in charge of [F16the business carried on at or from] those premises.

(4)The responsible pharmacist must be—

(a)the person carrying on the business, or

[F17(b)if the business is carried on by a partnership, one of the partners or, in Scotland, one of the partners who is a person registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners), or]

(c)another pharmacist.

F18(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F18(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

[F19 71 Business carried on by body corporateU.K.

(1)The conditions referred to in section 69(1)(b) of this Act are—

[F20(a)that there is a superintendent in relation to the retail pharmacy business in respect of whom the requirements specified in subsection (6) are fulfilled, and]

(b)that subsections (2) and (3) of this section are both satisfied as respects each of the premises [F21at or from which] the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2)This subsection is satisfied if a responsible pharmacist who satisfies [F22the requirement of subsection (4)] of this section is in charge of [F23the business carried on at or from] the premises mentioned in subsection (1)(b) of this section, so far as concerns—

(a)the retail sale at [F24or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F25or from] those premises of such products in circumstances corresponding to retail sale.

(3)This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

(a)the name of the responsible pharmacist for the time being,

[F26(b)the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and]

(c)the fact that he is for the time being in charge of [F27the business carried on at or from] those premises.

(4)The responsible pharmacist must be—

(a)the superintendent mentioned in subsection (1)(a) of this section, or

(b)a manager or assistant subject to the directions of the superintendent and who is a pharmacist.

F28(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F28(5A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6)The requirements referred to in subsection (1)(a) of this section in relation to a superintendent are that—

(a)he is a pharmacist,

[F29(aa)he is a senior manager of the retail pharmacy business who has the authority to make decisions that affect the running of the retail pharmacy business so far as concerns—

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

(ii)the supply of such products in circumstances corresponding to retail sale,

and]

(b)a statement in writing signed by him, and signed on behalf of the body corporate, specifying his name F30..., has been sent to the registrar F30...

F31(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F32(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F33(7A)For the purposes of subsection (6)(aa), a person is a senior manager of a retail pharmacy business if the person plays a significant role (irrespective of whether other individuals also do so) in—

(a)the making of decisions about how the whole or a substantial part of its activities are to be managed or organised, or

(b)the actual managing or organising of the whole or a substantial part of those activities.]

[F34(8)[F35If a person who has been the superintendent in relation to a retail pharmacy business ceases to be the superintendent in relation to the business] (otherwise than by reason of death) the person must notify the registrar in writing of that fact within the period of 28 days beginning with the day on which the person ceases to [F36be the superintendent in relation to the business].]

F37(9). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

72 Representative of pharmacist in case of death or disability.U.K.

(1)The provisions of this section shall have effect where a pharmacist carries on a retail pharmacy business and—

(a)he dies, or

(b)he is adjudged bankrupt or enters into a composition or scheme or deed of arrangement with his creditors, or, in Scotland, sequestration of his estate is awarded or he makes a trust deed for behoof of his creditors or a composition contract, or

(c)[F38he becomes a person who lacks capacity (within the meaning of the Mental Capacity Act 2005) to carry on the business], or, in Scotland, a [F39guardian] or judicial factor is appointed for him on the ground that he suffers from mental disorder, or, in Northern Ireland, [F40a controller is appointed in his case under the Mental Health (Northern Ireland) Order 1986],

and a representative of his thereafter carries on his business.

[F41(1A)In subsection (1)(c), the reference to a person who lacks capacity to carry on the business is to a person—

(a)in respect of whom there is a donee of an enduring power of attorney or lasting power of attorney (within the meaning of the Mental Capacity Act 2005), or

(b)for whom a deputy is appointed by the Court of Protection,

and in relation to whom the donee or deputy has power for the purposes of this Act.]

[F42(2)The conditions referred to in section 69(1)(c) of this Act are—

(a)that the name and address of the representative, and the name of the pharmacist whose representative he is, have been notified to the registrar, and

(b)that subsections (2A) and (2B) of this section are both satisfied as respects each of the premises at [F43or from] which the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2A)This subsection is satisfied if a responsible pharmacist is in charge of [F44the business carried on at or from] the premises mentioned in subsection (2)(b) of this section, so far as concerns—

(a)the retail sale at [F45or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F46or from] those premises of such products in circumstances corresponding to retail sale.

(2B)This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

(a)the name of the responsible pharmacist for the time being,

(b)[F47the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and]

(c)the fact that he is for the time being in charge of [F48the business carried on at or from] those premises.]

(3)The period referred to in section 69(1)(c) of this Act—

(a)in the case of the death of a pharmacist, is a period of five years from the date of his death;

(b)in the case of the bankruptcy or sequestration of the estate of a pharmacist, is a period of three years from the date on which he is adjudged bankrupt or the date of the award of sequestration, as the case may be;

(c)in the case of a composition or scheme or deed of arrangement, or of a trust deed or composition contract, is a period of three years from the date on which the trustee appointed thereunder becomes entitled to carry on the business; and

(d)in a case falling within subsection (1)(c) of this section, is a period of three years from the date of the appointment of the [F49deputy], [F50curator bonis,] judicial factor, committee or guardian [F51or from the date of registration of the instrument appointing the donee],

or, in any such case, is such longer period as, on the application of the representative, [F52the relevant disciplinary committee], having regard to all the circumstances of the case, may direct.

(4)In this section “representative”—

(a)in relation to a pharmacist who has died, means his executor or administrator and, in respect of a period of three months from the date of his death, if he has died leaving no executor who is entitled and willing to carry on the business, includes any person beneficially interested in his estate;

(b)in a case falling within paragraph (b) of subsection (1) of this section, means the trustee in bankruptcy or the trustee in the sequestration or any trustee appointed under the composition scheme, deed of arrangement, trust deed or composition contract; and

(c)in a case falling within paragraph (c) of that subsection, means the [F53donee, deputy], [F50curator bonis,] judicial factor, [F54controller] or guardian [F55; and in paragraph (b) above the reference to a trustee appointed under a composition, scheme or deed of arrangement includes a reference to the supervisor of a [F56voluntary arrangement proposed for the purposes of, and approved under, Part VIII of the Insolvency Act 1986] [F57or Chapter II of Part VIII of the Insolvency (Northern Ireland) Order 1989].]

[F5872AThe responsible pharmacistU.K.

[F59(A1)Nothing in this Part is to be taken as requiring there to be a responsible pharmacist in respect of premises at or from which a retail pharmacy business is carried on at a time when no medicinal products (whether they are on a general sale list or not) are being—

(a)offered or exposed for sale by retail or supply in circumstances corresponding to retail sale at or from the premises, or

(b)assembled, prepared or dispensed at or from the premises with a view to such sale or supply.]

(1)It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy [F60business carried on at or from] the premises in question so far as concerns—

(a)the retail sale at [F61or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F62or from] those premises of such products in circumstances corresponding to retail sale.

(2)A person may not be the responsible pharmacist in respect of more than one set of premises at the same time, except in circumstances specified by [F63the General Pharmaceutical Council in rules in relation to premises in Great Britain or the Council of the Pharmaceutical Society of Northern Ireland in regulations in relation to premises in Northern Ireland], and then only if such conditions as may be so specified are complied with.

F64(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F64(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F64(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F65(6)The General Pharmaceutical Council may make further provision in rules in relation to the responsible pharmacist in respect of premises in Great Britain, and the Council of the Pharmaceutical Society of Northern Ireland may make further provision in regulations in relation to the responsible pharmacist in respect of premises in Northern Ireland.

(6A)In making any such provision, the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland must have regard to the principle that the burdens imposed on businesses by rules or regulations should be the minimum necessary to secure the benefits, considered in general terms, which are expected to result from the rules or regulations.

(7)The rules and regulations mentioned in subsection (6) may (amongst other things)—

(a)make further provision about the matters mentioned in subsection (1);

(b)make provision about the responsible pharmacist’s absence from the premises.

(7A)If such rules or regulations make provision about the responsible pharmacist’s absence from the premises, they must also provide that the retail sale of medicinal products on a general sale list may continue at or from the premises during any period in which the responsible pharmacist is absent from the premises.]

F66(8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

[F6772AA.The superintendentU.K.

It is the duty of the superintendent in relation to a retail pharmacy business to secure that the business is at all times carried on in ways that ensure its safe and effective running so far as concerns—

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

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

[F5872B[F68Sections 72A and 72AA: supplementary]U.K.

[F69(1)The failure by a person to comply with any requirements of [F70section 72A or 72AA of this Act, or of rules or regulations made under section 72A,] may constitute misconduct for the purposes of section 80 of this Act, article 51(1)(a) of the Pharmacy Order 2010 and Article 20 of the Pharmacy (Northern Ireland) Order 1976 and the relevant disciplinary committee may deal with such a failure accordingly.]

F71(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)Subsection (4) of this section applies if a person—

(a)fails to comply with the requirements of subsection (2) of section 72A of this Act, or of [F72rules or] regulations made under that subsection,

(b)fails to comply with any requirements as to absence from the premises contained in [F73rules or] regulations made by virtue of [F74subsection (7)] of that section.

(4)If this subsection applies, the person in question is not to be considered while the failure continues as being in charge of [F75the business carried on at or from] the premises in question (or in a subsection (3)(a) case at any of them) for the purposes of sections 70 to 72 of this Act.]

73 Power to extend or modify conditions.U.K.

(1)The F76... Ministers may by order add to, revoke or vary any of the provisions of sections 70 to 72 of this Act, so as either—

(a)to modify, or provide new conditions in substitution for, the conditions referred to in any of the paragraphs of section 69(1) of this Act, or

(b)for the purposes of any of those paragraphs, to provide alternative conditions compliance with which is to have the like effect as compliance with the conditions referred to in that paragraph.

(2)Any provision made by an order in accordance with subsection (1) of this section may be made either generally or in relation to any particular circumstances specified in the order.

(3)Any order made under this section may direct that subsection (1) or subsection (2) of section 69 of this Act shall have effect subject to such exceptions or modifications as appear to the F77... Ministers to be necessary or expedient in consequence of the provision made by the order in accordance with subsection (1) of this section.

(4)Where an order under this section is for the time being in force, any reference to section 69 of this Act in any other enactment as amended by this Act shall be construed as a reference to that section as modified by the order.

(5)No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Registration of pharmaciesU.K.

74 Meaning of “registered pharmacy".U.K.

(1)F78. . . In this Act “registered pharmacy” means premises for the time being entered in the register F79....

[F80(1A)If the entry of a registered pharmacy in the register is suspended under [F81paragraph (4)(b) of article 14] [F81section 82A of this Act, paragraph 8 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976 or article 14(4)(b) or 56] of the Pharmacy Order 2010 then, except for such purposes [F82of that Order] as the General Pharmaceutical Council may prescribe by rules [F83in relation to Great Britain or the Council of the Pharmaceutical Society of Northern Ireland may prescribe by regulations in relation to Northern Ireland], that registered pharmacy must be treated as not being entered in the register notwithstanding that the register still includes the address of that pharmacy.]

[F80(1B)Accordingly, premises whose entry in the register is suspended are not to be treated as a registered pharmacy for the purposes of this Act or any other enactment [F84apart from that Order] [F84except for a purpose prescribed by the rules or regulations mentioned in subsection (1A)] .]

F85(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F86(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F85(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F8774A.Registration of premises: Great BritainU.K.

(1)This section applies in relation to premises in Great Britain.

(2)If the registrar is satisfied that the conditions in section 74B are met in relation to premises that are not entered in the register, the registrar must enter the premises in Part 3 of the register unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

(3)Subject to subsection (5) and to section 74H, the entry of premises entered in Part 3 of the register under subsection (2) is valid for the period of one year beginning with the date on which the entry was made.

(4)If the registrar is satisfied that the conditions in section 74B are met in relation to premises entered in Part 3 of the register under subsection (2), the registrar must renew the entry of the premises unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

(5)Subject to subsection (7) and to section 74H, each renewal of the entry of premises entered in Part 3 of the register under subsection (2) extends the validity of the entry for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid.

(6)The registrar may, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, renew the entry of premises in Part 3 of the register for a period exceeding one year beginning with the day on which the entry would otherwise have ceased to be valid in which case the renewal of the entry of premises entered in that part of the register under subsection (2) extends the validity of the entry for that period.

(7)If the entry of premises entered in Part 3 of the register under this section ceases to be valid then, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, the premises are to be treated for all purposes as no longer being entered in Part 3 of the register and accordingly the registrar must remove the entry from that part of the register.]

[F8774B.Conditions for registration: Great BritainU.K.

(1)The conditions referred to in section 74A are as follows.

(2)Condition A is that an application for the entry of the premises in Part 3 of the register or, as the case may be, for the renewal of the entry of the premises in Part 3 of the register is made—

(a)in such form and manner as is prescribed in rules made by the General Pharmaceutical Council; and

(b)if the application is an application for renewal, by such time prior to the entry ceasing to be valid as is so prescribed.

(3)Condition B is that the appropriate fee prescribed in rules made by the General Pharmaceutical Council under article 36(1) of the Pharmacy Order 2010 is paid.

(4)Condition C—

(a)if the application is an application for the entry of the premises in Part 3 of the register, is that either—

(i)the applicant is lawfully conducting a retail pharmacy business, or

(ii)if the premises are entered in Part 3 of the register, and the applicant begins to carry on a retail pharmacy business at [F88or from] the premises, the applicant will, from the time the applicant begins to do so, be a person lawfully conducting a retail pharmacy business; or

(b)if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is that the applicant is lawfully conducting a retail pharmacy business at [F89or from] the premises.

(5)Condition D—

(a)if the application is an application for the entry of the premises in Part 3 of the register, is that the standards that are [F90provided for in rules made] [F90set] under article 7(1) of the Pharmacy Order 2010 are met, or are capable of being met, in connection with the carrying on of a retail pharmacy business at [F91or from] the premises; or

(b)if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is—

(i)that the standards that are [F92provided for in rules made] [F92set] under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at [F93or from] the premises, and

(ii)that the requirements of rules [F94(if any)] made under article 7(4) of that Order are met by the person carrying on a retail pharmacy business at [F95or from] the premises.]

[F8774C.Supplementary provision in respect of registration of premises: Great BritainU.K.

(1)The registrar may restore to Part 3 of the register the entry of premises removed from that part of the register by virtue of section 74A(7) if an application is made to the registrar in accordance with this section.

(2)An entry restored under this section to Part 3 of the register—

(a)is still to be treated as having been entered in that part of the register under section 74A;

(b)is valid for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid by virtue of section 74A(7) or is valid for such longer period beginning with that day as the registrar may in any particular case allow; and

(c)may be subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of section 74A(7) or may be subject to such other conditions as the registrar may impose under section 74D(1).

(3)An application for restoration may be made to the registrar by the person who is the owner of the retail pharmacy business previously carried on at [F96or from] the premises and that person must be—

(a)a person who is lawfully conducting a retail pharmacy business; or

(b)a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at [F97or from] the premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

(4)The General Pharmaceutical Council may make rules in connection with applications under this section.

(5)Rules under subsection (4) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

(b)about the information to be provided in respect of applications; and

(c)about the circumstances in which applications must or, as the case may be, may be refused (including where an application for renewal under this section was not received by the registrar by the time prescribed by the General Pharmaceutical Council in rules under section 74B(2)(b)).

(6)Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under this section, the registrar must give notice in writing of that restoration to the applicant.

(7)The notice under subsection (6) must specify—

(a)the period for which the entry restored to Part 3 of the register is valid;

(b)any conditions to which that entry is subject by virtue of subsection (2)(c).

(8)The notice under subsection (6) must be sent—

(a)where the retail pharmacy business was carried on by an individual, to that individual at that individual’s home address in the register;

(b)where the retail pharmacy business was carried on by a partnership, to that partnership at its principal office;

(c)where the retail pharmacy business was carried on by a body corporate, to that body corporate at its registered or principal office.]

[F8774D.Conditional registration: Great BritainU.K.

(1)The registrar may make the entry of premises entered in Part 3 of the register under section 74A subject to such conditions as the registrar considers it necessary to impose for the purpose of securing the safe and effective practice of pharmacy [F98in the course of the business carried on at or from] those premises.

(2)The power under subsection (1)—

(a)may be exercised on the making of the entry or subsequently (whether on a renewal of the entry or otherwise);

(b)includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

(3)Except as provided in subsection (4), the registrar may not under subsection (1)—

(a)impose a new condition in respect of premises already entered in Part 3 of the register; or

(b)vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on the retail pharmacy business at [F99or from] the premises and of the date from which that condition, variation or revocation is to have effect.

(4)The registrar may, with immediate effect—

(a)impose a new condition in respect of premises already entered in Part 3 of the register; or

(b)vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

if, in the registrar’s opinion, the giving of reasonable notice as required by subsection (3) would prejudice the health, safety or well-being of members of the public.

(5)The registrar must give notice in writing of any decision under subsection (4) to the person carrying on a retail pharmacy business at [F100or from] the premises.

(6)The notice under subsection (5) must be sent—

(a)where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

(b)where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office; or

(c)where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered or principal office.

(7)Where premises are entered in the register because condition C in section 74B is met by virtue of subsection (4)(a)(ii) of that section, the registrar may, on making the entry of the premises in the register, also make that entry subject to a condition that the applicant for registration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is made.]

[F8774E.Supplementary provision in respect of conditional registration: Great BritainU.K.

(1)Where the entry of premises entered in Part 3 of the register is subject to conditions imposed under section 74D(1), the person carrying on the business at [F101or from] the premises may apply to the registrar for any of the conditions imposed to be varied or revoked.

(2)The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(3)Rules under subsection (2) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

(b)about the information to be provided in respect of applications;

(c)about the circumstances in which applications may be refused by the registrar;

(d)about the giving of notice of the decision in respect of the application to the applicant by the registrar.

(4)The registrar may vary a condition imposed under section 74D(7) by extending the period within which the applicant for registration must become a person lawfully conducting a retail pharmacy business.

(5)Where premises are entered in the register subject to a condition imposed under subsection (7) of section 74D, the registrar may remove the entry if the applicant is not a person lawfully conducting a retail pharmacy business at [F102or from] the premises within the period determined by the registrar in accordance with that subsection or within such longer period as the registrar may, by virtue of subsection (4), allow.

(6)Where the registrar—

(a)varies a condition under subsection (5); or

(b)removes an entry of premises in Part 3 of the register under subsection (4),

the registrar must send to the person who applied for registration a statement in writing giving that person notice of the decision and the reasons for it.

(7)The notice under subsection (6) must be sent—

(a)where the person who applied for registration is an individual, to that individual at that individual’s home address in the register;

(b)where that person is a partnership, to that partnership at its principal office;

(c)where that person is a body corporate, to that body corporate at its registered or principal office.]

[F8774F.Giving of notice by registrar: Great BritainU.K.

(1)Where, in pursuance of an application, the registrar enters premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the entry.

(2)The written confirmation under subsection (1) must include—

(a)the number of the entry;

(b)the date on which the entry was made;

(c)the period for which the entry is valid; and

(d)details of any conditions to which the entry is subject by virtue of section 74D.

(3)Where, in pursuance of an application, the registrar renews the entry of premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the renewal.

(4)The written confirmation under subsection (3) must include—

(a)the number of the entry;

(b)the date on which the renewal of the entry was made;

(c)the period for which the renewal of the entry is valid; and

(d)details of any conditions to which the renewal of the entry is subject by virtue of section 74D.

(5)Where the registrar refuses an application for the entry of premises in Part 3 of the register under section 74A, or for the renewal of an entry of premises in the register under that section, the registrar must give to the applicant written notice of that refusal and the reasons for it and of the right of appeal to the Appeals Committee under article 40 of the Pharmacy Order 2010.

(6)Where, under section 74J, the registrar enters premises or a group of premises in Part 3 of the register, the registrar must give written confirmation of the entry to the person who will be carrying on a retail pharmacy business at [F103or from the premises, or at or from] each set of premises in the group of premises.

(7)The written confirmation under subsection (6) must include—

(a)the number of the entry;

(b)the date on which the entry was made; and

(c)details of any conditions to which the entry is subject by virtue of section 74J(4).]

[F8774G.Voluntary removal from the register: Great BritainU.K.

(1)An application may be made to the registrar by the person carrying on a retail pharmacy business at [F104or from] any premises entered in Part 3 of the register under section 74A or 74J for the premises to be removed from the register.

(2)The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(3)Rules under subsection (2) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b)about the information to be provided by the applicant;

(c)about the circumstances in which applications may be refused; and

(d)for written notice of the outcome of the application to be given to the applicant by the registrar.]

[F8774H.(1)Subject to subsection (2), where a change occurs in the ownership of a retail pharmacy business carried on at [F105or from] premises entered in Part 3 of the register under section 74A, the entry of the premises in the register ceases to be valid at the end of the relevant period unless the registrar is notified in writing of the change prior to the end of the relevant period by the person who, as a result of the change, will be the person carrying on the business at [F106or from] the premises.U.K.

(2)Subsection (1) only applies if the relevant period is shorter than the period for which the entry would otherwise have remained valid under section 74A.

(3)Where, before the end of the relevant period, the registrar is notified of a change in the ownership of a retail pharmacy business carried on at [F107or from] premises entered in Part 3 of the register, the registrar must, on receipt of a fee of the amount prescribed in rules under article 36(1)(c) of the Pharmacy Order 2010, amend the entry relating to the premises in Part 3 of the Register to record the name and address of the person who, as a result of the change, will be the person carrying on the retail pharmacy business at [F108or from] the premises.

(4)For the purposes of subsections (1) to (3), the relevant period—

(a)if the change occurs on the death of the person carrying on the business or, in the case of a partnership, on the death of one of the partners, means the period of three months beginning with the date of death; and

(b)in any other case, means the period of 28 days beginning with the date on which the change occurred.

(5)If the entry of premises entered in Part 3 of the register under section 74A ceases to be valid under this section, the premises are to be treated for all purposes as no longer being entered in the register and accordingly the registrar must remove the entry from the register.

(6)The registrar must restore the entry of the premises to Part 3 of the register if—

(a)an application for restoration is made to the registrar in accordance with section 74I(1) and with rules made under section 74I(3);

(b)a fee of an amount prescribed in rules under article 36(1)(b) of the Pharmacy Order 2010 (fees in connection with entry) is paid; and

(c)the registrar is satisfied that the standards that are [F109provided for in rules made] [F109set] under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at [F110or from] the premises.

(7)Subject to subsection (8), an entry restored to the register under subsection (6)—

(a)is still to be treated as having been entered in Part 3 of the register under section 74A;

(b)is subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of subsection (5);

(c)is valid for the same period as the period for which the entry would have been valid under section 74A had it not been removed from Part 3 of the register by virtue of subsection (5) of this section.

(8)Where an entry of premises in Part 3 of the register is restored by the registrar under subsection (6) and the applicant is a person falling within section 74I(2)(b), the registrar may—

(a)on restoring the entry of the premises to the register, make that entry subject to a condition that the applicant for restoration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is restored; and

(b)subsequently remove the entry of the premises from Part 3 of the register if the applicant is not a person lawfully conducting a retail pharmacy business within the period determined by the registrar in accordance with paragraph (a).

(9)Where under subsection (8)(b) the registrar removes an entry of premises from Part 3 of the register, the registrar must give to the person who was carrying on a retail pharmacy business at [F111or from] the premises immediately prior to the removal written notice of the removal and the reasons for it.

(10)The notice under subsection (9) must be sent—

(a)where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

(b)where the retail pharmacy business is carried on by a partnership, to the principal office of that partnership;

(c)where the retail pharmacy business is carried on by a body corporate, to the registered or principal office of that body corporate.]

[F8774I.Supplementary provision in respect of change of ownership of retail pharmacy business: Great BritainU.K.

(1)An application may be made to the registrar for the entry of premises removed from Part 3 of the register by virtue of section 74H(5) to be restored to the register.

(2)An application under subsection (1) must be made by the person who, in consequence of the change of ownership, has become the owner of the business and that person must be—

(a)a person who is lawfully conducting a retail pharmacy business; or

(b)a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at [F112or from] those premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

(3)The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(4)Rules under subsection (3) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b)about the information to be provided in respect of applications;

(c)about the circumstances in which an application for restoration under subsection (1) may be treated by the registrar as an application for the renewal of registration under section 74A(4) as well as an application for restoration.

(5)Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under subsection (1), the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the restoration.

(6)The notice given by the registrar under subsection (5) must specify—

(a)the period for which the entry restored to Part 3 of the register is valid;

(b)any conditions to which the entry of the premises restored to Part 3 of the register is subject.

(7)Where the registrar refuses an application under this section for the restoration to Part 3 of the register of an entry relating to any premises, the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the decision and the reasons for it.

(8)The notice under subsections (5) and (7) must be sent—

(a)where the applicant is an individual, to that individual at that individual’s home address in the register;

(b)where the applicant is a partnership, to the principal office of that partnership;

(c)where the applicant is a body corporate, to the registered or principal office of that body corporate.]

[F8774J.Temporary registration with regard to emergencies involving loss of human life or human illness etc.U.K.

(1)This section applies in relation to premises in Great Britain.

(2)If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may under this section enter in Part 3 of the register—

(a)premises; or

(b)premises comprising a specified group of premises,

with regard to the emergency.

(3)The registrar may enter in Part 3 of the register by virtue of subsection (2)(b) all of the premises in a specified group of premises without first identifying each set of premises in the group.

(4)The registrar may make the entry of premises entered in Part 3 of the register under this section subject to such conditions as the registrar considers necessary to impose for the purpose of securing the safe and effective practice of pharmacy [F113in the course of the business carried on at or from] those premises.

(5)The power in subsection (4)—

(a)may be exercised on the making of the entry or subsequently;

(b)includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

(6)The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group may be subject to the same conditions as the entry of the other premises in the group or it may be subject to different conditions.

(7)The conditions to which the entry of premises entered in Part 3 of the register under this section is subject may include conditions relating to their physical state, safety and security and the conditions in which medicinal products (including controlled drugs) are stored at those premises.

(8)The registrar may not under subsection (4)—

(a)impose a new condition in respect of the entry of premises already entered in Part 3 of the register; or

(b)vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on a retail pharmacy business at [F114or from] the premises and of the date from which that condition, variation or revocation is to have effect.

(9)The entry of premises entered in Part 3 of the register under this section may be removed by the registrar, which—

(a)the registrar must do if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (2) no longer exist;

(b)the registrar may do for any other reason at any time including where the registrar has grounds for suspecting that there is a failure to comply with any conditions to which the entry of the premises in Part 3 of the register is subject.

(10)The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group of premises may be removed without removing the entries of the other premises in the group, or it may be removed by virtue of a decision to remove the entries of all of the premises in the group.

(11)In this section, and in section 74K, “emergency” means an emergency of the type described in subsection (1)(a) of section 19 of the Civil Contingencies Act 2004 (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.]

[F8774K.Temporary annotations with regard to emergencies involving loss of human life or human illness etc.U.K.

(1)If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may annotate—

(a)the entry of a registered pharmacy entered in Part 3 of the register under section 74J to designate that pharmacy as a pharmacy from which drugs, medicines and appliances may be ordered in a specified capacity; or

(b)the entries of a specified group of registered pharmacies entered in Part 3 of the register under section 74J to designate that group as a group of pharmacies from which drugs, medicines and appliances may be ordered in a specified capacity.

(2)The registrar may make an annotation, by virtue of subsection (1), to the entry of a registered pharmacy entered in Part 3 of the register under section 74J in such a way as to distinguish that annotation from an annotation in respect of a registered pharmacy made otherwise than by virtue of subsection (1).

(3)Annotations made by virtue of subsection (1)—

(a)must be removed by the registrar if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (1) no longer exist;

(b)may be removed by the registrar for any other reason at any time.

(4)An annotation of the entry of a registered pharmacy made by virtue of subsection (1)(b) as one of a specified group may be removed without removing the annotations of the entries of the other registered pharmacies in the group, or it may be removed by virtue of a decision to remove the annotations of the entries of all the registered pharmacies in the group.]

[F8774L.Evidence of registration: Great BritainU.K.

A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises in Great Britain were, or were not, entered in Part 3 of the register (whether under section 74A or section 74J) is admissible in any proceedings as evidence (or in Scotland, as sufficient evidence) that those premises were, or were not, entered in the register on that date.]

75 Registration of premises[F115: Northern Ireland]. U.K.

[F116(A1)This section applies in relation to premises in Northern Ireland.]

(1)It shall be the duty of the registrar to keep a register for the purposes of this section F117... and, subject to the following provisions of this section, on payment of the prescribed fee to enter in the register any premises in respect of which an application is made under this section.

(2)Any application for the registration of premises under this section shall be made in the prescribed manner and shall specify the premises to which the application relates and shall contain such other particulars as may be prescribed.

(3)On the making of any such application the registrar shall notify the appropriate Minister, specifying the premises to which the application relates and the date on which the application was made, and shall not enter those premises in the register before the end of the period of two months from that date, unless before the end of that period the appropriate Minister consents to his doing so.

(4)If it appears to the appropriate Minister that in a material respect the premises do not comply with the requirements of regulations made under section 66 of this Act which are for the time being in force, and accordingly he proposes to certify that the premises are unsuitable for registration under this section, he shall, before the end of the period referred to in subsection (3) of this section, serve on the applicant a notice stating his proposals and the reasons for them, and shall serve a copy of that notice on the registrar; and, where a copy of such a notice is served on him, the registrar shall not enter the premises in the register except where required to do so in accordance with the following provisions of this section.

(5)If, within the time allowed after the service on him of a notice under subsection (4) of this section, the applicant gives notice to the appropriate Minister of his desire to be heard with respect to the proposals, or makes representations in writing to the appropriate Minister with respect to the proposals, then, before determining whether to issue a certificate under this section in respect of the premises,—

(a)if the applicant has given notice of his desire to be heard, the appropriate Minister shall afford to him an opportunity of appearing before, and being heard by, a person appointed by that Minister for the purpose, or

(b)if he has made representations in writing, that Minister shall consider those representations.

(6)Where the appropriate Minister has served a notice under subsection (4) of this section, then—

(a)if he determines not to issue a certificate certifying that the premises are unsuitable for registration under this section, he shall notify the applicant and the registrar of his decision and (subject to subsection (7) of this section) the registrar shall forthwith enter the premises in the register;

(b)if the appropriate Minister issues such a certificate, he shall transmit the certificate to the registrar and shall notify the applicant that he has done so, and, if so required by the applicant, shall inform him of the reasons for his decision to issue such a certificate.

(7)Notwithstanding anything in the preceding provisions of this section, the registrar shall not enter any premises in the register in pursuance of an application under this section unless it is shown to his reasonable satisfaction either—

(a)that at the time of the application the applicant is a person lawfully conducting a retail pharmacy business, or

(b)that, if the premises are entered in the register, and the applicant begins to carry on a retail pharmacy business at [F118or from] those premises, then as from the time when he begins to do so he will be a person lawfully conducting a retail pharmacy business.

(8)In this section “the appropriate Minister”—

F119(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F119(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)F120... means the Minister of Health and Social Services for Northern Ireland,

and “the time allowed” means the period of twenty-eight days or such extended period as the appropriate Minister may in any particular case allow.

76 Supplementary provisions as to registration of premises[F121: Northern Ireland].U.K.

(1)Where any premises have been entered in the register [F122under section 75], then, in respect of each year subsequent to the year in which the premises were so entered, a further fee (in this section referred to as a “retention fee") of the prescribed amount shall be payable by the person carrying on a retail pharmacy business at [F123or from] those premises.

(2)If, on demand being made to him in the prescribed manner, the person carrying on a retail pharmacy business at [F124or from] any premises entered in the register [F125under section 75] fails to pay a retention fee in respect of those premises within two months from the date on which the demand is made, [F126the appropriate Minister] may direct the registrar to remove the premises from the register; but if, before the end of the year in respect of which the retention fee is payable or such longer period as in any particular case [F126the appropriate Minister] may allow, the person carrying on the business pays to the registrar the retention fee in respect of that year, together with such additional sum (if any) by way of penalty as may be prescribed,—

(a)the registrar shall restore the premises to the register, and

(b)if [F126the appropriate Minister] so [F127directs], the restoration shall be deemed to have had effect as from the date on which the premises were removed from the register.

(3)Where a change occurs in the ownership of a retail pharmacy business carried on at [F128or from] any premises registered under section 75 of this Act, the registration of the premises under that section—

(a)if the change occurs on the death of the person carrying on the business, or, in the case of a partnership, on the death of one of the partners, shall become void at the end of the period of three months from the date of the death, and

(b)in any other case, shall become void at the end of the period of twenty-eight days from the date on which the change occurs.

F129(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5)Where the registration of any premises under section 75 of this Act in respect of a business becomes void by virtue of subsection (3) of this section, an application for the premises to be restored to the register may be made by the person who, in consequence of the change of ownership, has become the owner of the business; and where such an application is made, and it is shown to the reasonable satisfaction of the registrar either—

(a)that at the time of the application the applicant is a person lawfully conducting a retail pharmacy business, or

(b)that, if the premises are restored to the register, and the applicant thereafter carries on a retail pharmacy business at [F130or from] those premises, then as from the time when he begins to do so he will be a person lawfully conducting a retail pharmacy business,

and (in a case where, if the registration had not become void, a retention fee would have become payable) a fee equal to a retention fee has been paid, the registrar shall restore the premises to the register.

F131(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7)A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises [F132in Northern Ireland] were, or were not, entered in the register shall be admissible in any proceedings as evidence (and, in Scotland, shall be sufficient evidence) that those premises were, or were not, entered in the register on that date.

F133(8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F134(9)In this section—

• “the appropriate Minister” means the Minister of Health, Social Services and Public Safety for Northern Ireland;

• “year” means a period of 12 months beginning with such date as the appropriate Minister may from time to time determine.]

77 Annual return of premises to registrar.U.K.

Every person who carried on a retail pharmacy business [F135at [F136or from] premises in Northern Ireland] shall, in the month of January in each year, send to the registrar—

(a)a list of all [F137such] premises at [F138or from] which his business, so far as it consists of the retail sale of medicinal products, is carried on, and

F139(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provisions as to use of certain titles, descriptions and emblemsU.K.

78 Restrictions on use of titles, descriptions and emblems.U.K.

(1)The provisions of this section shall have effect subject to section 79 of this Act.

(2)F140... No person shall—

(a)take or use any of the following titles, that is to say, chemist and druggist, druggist, dispensing chemist, and dispensing druggist, or

(b)take or use the title of chemist in connection with the sale of any goods by retail or the supply of any goods in circumstances corresponding to retail sale,

unless the conditions specified in the next following subsection are fulfilled.

(3)Those conditions are—

(a)in the case of an individual, that he is a person lawfully conducting a retail pharmacy business (either alone or as a member of a partnership) and that he does not take or use the title in question in connection with any premises at [F141or from] which any goods are sold by retail, or are supplied in circumstances corresponding to retail sale, unless those premises are a registered pharmacy, and

(b)in the case of a body corporate, that the body is a person lawfully conducting a retail pharmacy business and that the title in question is not taken or used by that body in connection with any premises at [F142or from] which any goods are sold by retail, or are supplied in circumstances corresponding to retail sale, unless those premises are a registered pharmacy F143....

(4)F140... No person shall, in connection with a business carried on by him which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, use the description “pharmacy” except in respect of a registered pharmacy or in respect of the pharmaceutical department of a hospital or a health centre.

[F144(5)A person who is not registered in the register of pharmaceutical chemists for Northern Ireland F145... made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 may not—

(a)take or use the title pharmaceutical chemist, pharmaceutist, pharmacist, member of the Pharmaceutical Society of Northern Ireland or Fellow of the Pharmaceutical Society of Northern Ireland; or

(b)take or use any of the titles mentioned in paragraph (a) in connection with a business carried on (whether by him or by some other person) at [F146or from] any premises which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, unless those premises are a registered pharmacy or a hospital or health centre.

(5A)A person who is not registered as a pharmacist in Part 1 F147... of the register maintained under article 19 of the Pharmacy Order 2010 may not take or use the title pharmacist or fferyllydd (its equivalent in the Welsh language) in connection with a business carried on (whether by him or by some other person) at [F148or from] any premises which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, unless those premises are a registered pharmacy or a hospital or health centre.

(5B)Subsection (5) extends to Northern Ireland only; and subsection (5A) does not extend there.]

(6)F140... No person shall, in connection with any business, use any title, description or emblem likely to suggest—

(a)that he possesses any qualification with respect to the sale, manufacture or assembly of medicinal products which he does not in fact possess, or

(b)that any person employed in the business possesses any such qualification which that person does not in fact possess.

(7)For the purposes of the last preceding subsection the use of the description “pharmacy", in connection with a business carried on at [F149or from] any premises, shall be taken to be likely to suggest that the person carrying on the business (where that person is not a body corporate) is a pharmacist and that any other person, [F150 who is in charge of [F151the business carried on at or from] those premises (so far as concerns the retail sale of medicinal products or the supply of such products in circumstances corresponding to retail sale) is also a pharmacist].

(8)Where a person is lawfully conducting a retail pharmacy business as being a representative of a pharmacist in the circumstances specified in section 69(1)(c) of this Act, subsections (5) to (7) of this section shall not have effect so as to prevent the representative from taking or using, in connection with that business, any title, description or emblem which the pharmacist himself could have used in accordance with those subsections.

79 Provision for modifying or extending restrictions under s. 78.U.K.

(1)The F152... Ministers may by order provide that any of the restrictions imposed by section 78 of this Act shall cease to have effect, or shall have effect subject to such exceptions as may be specified in the order.

(2)Without prejudice to the preceding subsection, regulations made by the F153... Ministers may (in addition to the restrictions for the time being having effect by virtue of section 78 of this Act) impose such further restrictions or other requirements with respect to the use of titles, descriptions and emblems as may be specified in the regulations.

(3)Without prejudice to the application of section 129(6) of this Act, before making any order or regulations under this section the F154... Ministers shall consult [F155the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland].

(4)Regulations made under this section shall be of no effect unless a draft of the regulations has been laid before Parliament and approved by a resolution of each House of Parliament.

Disqualification, and removal of premises from registerU.K.

80 Power for [F156relevant disciplinary committee] to disqualify and direct removal from register.U.K.

[F157(1)Where a body corporate carries on a retail pharmacy business and—

(a)that body is convicted of an offence under one of the relevant Acts;

(b)any member of the board or any officer of, or person employed by, that body is convicted of an offence, or has been guilty of misconduct, and the offence or misconduct is such as in the opinion of the relevant disciplinary committee renders him, or would if he were a pharmacist, render him unfit to be a pharmacist; or

(c)in respect of premises [F158in Great Britain] that are entered in the register as premises at [F159or from] which the body corporate carries on that business, there is a failure to meet the standards that are [F160provided for in rules made under] [F160set under Article 5A(1) of the Pharmacy (Northern Ireland) Order 1976 or] article 7(1) of the Pharmacy Order 2010 in connection with the carrying on of the business at [F161or 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 body corporate is to be disqualified for the purposes of this Part of this Act.]

[F162(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 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.]

(2)In any case falling [F163within the preceding subsection] [F163within subsection (1) or (1A)] —

(a)if the [F164the relevant disciplinary committee] give a direction under [F165that subsection] [F165the subsection in question], they shall direct the registrar to remove from the register all premises entered in the register as being premises at [F166or from] which the body corporate[F167, the pharmacist or the partnership] carries on a retail pharmacy business;

(b)if the [F164the relevant disciplinary committee] do not give a direction under [F168the preceding subsection] [F168the subsection in question], they may, if they think fit, direct the registrar to remove from the register all those premises, or such of them as may be specified in the direction under this paragraph.

[F169(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.]

(3)Directions under subsection (1) [F170or (1A)] of this section and under paragraph (a) of [F171the last preceding subsection] [F171subsection (2)], and any direction under paragraph (b) of [F171the last preceding subsection] [F171subsection (2)], may, if the [F172the relevant disciplinary committee] think fit, be given so as to have effect for a limited period; and in that case the registrar, at the end of that period, shall restore to the register any premises removed from it in compliance with the direction given under paragraph (a) or paragraph (b) of [F171the last preceding subsection] [F171subsection (2)].

(4)Where, in any such case as is mentioned in subsection (1) of section 72 of this Act, a representative, or a person employed by a representative in the business referred to in that subsection,—

(a)is convicted of an offence, or

(b)has been guilty of misconduct,

and the offence or misconduct is such as in the opinion of the [F173the relevant disciplinary committee] renders him, or would if he were a pharmacist render him, unfit to be a pharmacist, then, subject to the following provisions of this Part of this Act, the [F173the relevant disciplinary committee], after inquiring into the case, may direct that the representative shall be disqualified for the purposes of this Part of this Act.

(5)In this and the next following section “the relevant Acts” means [F174the Pharmacy Act 1954, this Act, the Misuse of Drugs Act 1971, the Pharmacy (Northern Ireland) Order 1976, the Pharmacists and Pharmacy Technicians Order 2007 and the Pharmacy Order 2010], and “representative” has the same meaning as in section 72 of this Act.

81 Grounds for disqualification in certain cases.U.K.

[F175(1)Unless the conditions specified in subsection (1A) are satisfied, the relevant disciplinary committee may not do any of the following—

(a)give a direction under subsection (1) of section 80 of this Act—

(i)in a case falling within paragraph (b) of that subsection, or

(ii)in a case falling within paragraph (c) of that subsection, where the failure in question is by a member of the board or any officer of, or person employed by, the body in question; or

(b)give a direction under subsection (4) of that section.

(1A)The conditions are that—

(a)one or more of the facts specified in subsection (2) are proved to the satisfaction of the relevant disciplinary committee; and

(b)the committee are of the opinion, having regard to those facts, that the board of the body corporate or, as the case may be, the representative, is to be regarded as responsible for the offence, misconduct or failure in question.]

(2)[F176The facts referred to in subsection (1A)(a) of this section are]-

(a)that [F177the offence, misconduct or failure in question] was instigated or connived at by the board or by a member of the board, or by the representative, as the case may be;

[F178(b)that, in the case of a body corporate, a member of the board, or an officer of, or person employed by, the body corporate had, at some time within the twelve months immediately preceding the date on which the offence, misconduct or failure occurred, been guilty of a similar offence or failure or of similar misconduct and that the board had, or with the exercise of reasonable care would have had, knowledge of that previous offence, misconduct or failure;]

(c)that, in the case of the representative, he or a person employed by him had, at some time within twelve months before the date on which the offence or misconduct in question occurred, been guilty of a similar offence or similar misconduct and (where it was a similar offence or similar misconduct on the part of an employee) that the representative had, or with the exercise of reasonable care would have had, knowledge of that previous offence or misconduct;

(d)if [F179offence, misconduct or failure in question is a continuing offence or failure or is continuing misconduct], that the board, or the representative, had, or with the exercise of reasonable care would have had, knowledge of its continuance;

(e)in the case of an offence in respect of a contravention of an enactment contained in any of the relevant Acts, that the board, or the representative, had not exercised reasonable care to secure that the enactment was complied with.

82 Procedure relating to disqualification.U.K.

(1)[F180The relevant disciplinary committee] shall not give a direction under section 80 of this Act except with the assent of the chairman of the Committee.

(2)A direction under that section shall not take effect until the end of the period of three months from the date on which notice of the direction is given to the body corporate[F181, pharmacist, partnership] or other person to whom it relates, and, if an appeal against the direction is brought under this section, shall not take effect until that appeal has been determined or withdrawn.

(3)Where any such direction is given, the body corporate[F182, pharmacist, partnership] or other person to whom it relates may, at any time before the end of the period of three months specified in subsection (2) of this section, appeal against the direction to the High Court.

(4)The [F183General Pharmaceutical Council or, in Northern Ireland, the Pharmaceutical Society of Northern Ireland] may appear as respondent on any such appeal; and, for the purpose of enabling directions to be given as to costs on any such appeal, the [F184Council or the Society] shall be deemed to be a respondent to the appeal whether they appear on the hearing of the appeal or not.

(5)On any such appeal, the High Court may give such directions in the matter as appear to the Court to be appropriate; and it shall be the duty of [F185the relevant disciplinary committee] to comply with any such directions and (where appropriate) of the registrar to make such alterations in the register as are necessary to give effect to them.

(6)No appeal shall lie from any decision of the High Court under this section.

(7)In the application of this section to Scotland, any reference to the High Court shall be construed as a reference to the Court of Session, and any reference to costs shall be construed as a reference to expenses.

(8)In the application of this section to Northern Ireland, any reference to the High Court shall be construed as a reference to a judge of the [F186 Court of Judicature ] of Northern Ireland.

[F18782A.Interim measuresU.K.

(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.]

83 Revocation of disqualification.U.K.

(1)At any time while a direction under section 80 of this Act is in force [F188the relevant disciplinary committee], either on the application of the person to whom it relates or without any such application, may revoke the direction.

(2)If, on an application to [F189the relevant disciplinary committee] to revoke such a direction, [F190the committee] refuse to revoke it, the applicant, at any time before the end of the period of three months from the date on which notice of the refusal is given to him, may appeal to the High Court against the refusal.

(3)Subsections (4) to (6) of section 82 of this Act shall have effect in relation to any appeal under this section as they have effect in relation to appeals under that section.

(4)In the application of this section to Scotland, any reference to the High Court shall be construed as a reference to the Court of Session; and in the application of this section to Northern Ireland, any reference to the High Court shall be construed as a reference to a judge of the [F186 Court of Judicature ] of Northern Ireland.

Supplementary provisionsU.K.

84 Offences under Part IV.U.K.

F191(A1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(1)Any person who contravenes section 77 of this Act shall be guilty of an offence and liable on summary conviction to a fine not exceeding [F192level 3 on the standard scale].

(2)Any person who contravenes section 78 of this Act or who contravenes any regulations made under section 79(2) of this Act shall be guilty of an offence and liable on summary conviction to a fine not exceeding [F193level 3 on the standard scale].

[F19484A.Rules by the General Pharmaceutical CouncilU.K.

(1)The General Pharmaceutical Council may make such provision as it considers appropriate in rules for any purpose for which rules are authorised or required to be made by it under Part 4 of this Act.

(2)Article 66 of the Pharmacy Order 2010 (rules) applies to the making of rules by the General Pharmaceutical Council under [F195any provision of Part 4 of this Act other than section 72A] as it applies to the making of rules by the General Pharmaceutical Council under Part 3 of that Order (registered pharmacies: standards in retail pharmacies).]

[F196(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.]