Legalize / United Kingdom / Statutory-Instrument

The Pharmacy Order 2010

Type Statutory-Instrument

Publication 2010-02-10

Last updated 2026-01-07

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(a) for securing that, where a hearing is to be held, notice of when and where the hearing is to be held is given, at such time and in such manner as may be specified in the rules, to any person to whom the proceedings relate;

(b) for securing that the person concerned (which for the purposes of this article, where appropriate, includes an individual who, or partnership or body corporate which, is subject to disqualification proceedings under Part 4 of the Medicines Act 1968) and the Council are, if they so require, entitled to be heard by the committee—

(i) at any hearing, or

(ii) in fitness to practise proceedings or on any other occasion when the committee is considering making an interim suspension order or an order for interim conditional entry;

(c) for allowing the person concerned and the Council to be represented at any hearing, or in fitness to practise proceedings or on any other occasion when the committee is considering making an interim suspension order or an order for interim conditional entry, by—

(i) a person with a general qualification (within the meaning of section 71 of the Courts and Legal Services Act 1990[^f00052] (offences)),

(ii) an advocate in Scotland, or a solicitor with rights of audience to appear in the Court of Session or in the High Court of Justiciary by virtue of section 25A of the Solicitors (Scotland) Act 1980[^f00053] (rights of audience in the Court of Session etc.), or

(iii) a person of such other description as may be specified in rules, if the rules so allow and the person concerned or the Council so elects;

(d) for proceedings before the committee to be held in public, except and to the extent that rules provide otherwise; and

(e) in respect of reviewing directions under article 54—

(i) which are due to expire,

(ii) in circumstances where the committee is considering varying the requirements specified in the direction, or

(iii) in the case of a direction for suspension or for conditional entry—

(aa) at the request of the Registrar or the person concerned, or

(bb) upon new evidence becoming available.

(3) The rules under paragraph (1) may include provision—

(a) in respect of preliminary consideration of a case before a committee (including considering representations from the person concerned and the Council during its preliminary consideration);

(b) following preliminary consideration of a case—

(i) in the case of an appeal before the Appeals Committee, allowing the Appeals Committee, in prescribed circumstances, to allow the appeal or take a decision which has the effect of allowing the appeal,

(ii) in fitness to practise proceedings, allowing the Fitness to Practise Committee, in prescribed circumstances, to make a finding that the fitness to practise of the person concerned is not impaired, and

(iii) in a disqualification case, allowing the Fitness to Practise Committee, in prescribed circumstances, to dismiss the case;

(c) in respect of consensual disposal of a fitness to practise case following preliminary consideration of it, including provision—

(i) enabling the Investigating Committee or the Fitness to Practise Committee, in prescribed circumstances, to agree with the person concerned that the person concerned will comply with such undertakings as the committee considers appropriate, and

(ii) with respect to the procedure to be followed when any such undertakings are breached (the rules may provide that the breach may be treated as misconduct for the purposes of article 51(1)(a) and for the matter to be dealt with as a misconduct allegation that is before the committee);

(d) in respect of consensual disposal of a disqualification case following preliminary consideration of it, including provision—

(i) enabling the Fitness to Practise Committee, in prescribed circumstances, to agree with the individual , partnership or body corporate that the individual , partnership or body corporate will comply with such undertakings as the Committee considers appropriate, and

(ii) with respect to the procedure to be followed where any such undertakings are breached;

(e) in respect of case management meetings (and the rules may provide that the preliminary consideration of a case is to take place at a case management meeting) and directions, including provision with respect to the procedure to be followed where case management directions are breached;

(f) in respect of cancelling, postponing or adjourning hearings and staying proceedings in appropriate circumstances;

(g) enabling the Appeals Committee to refer a case before it to the Investigating Committee or the Fitness to Practise Committee for advice;

(h) enabling the Fitness to Practise Committee to draw such inference as seems appropriate to it in the particular circumstances of the case if the person concerned fails—

(i) during fitness to practise proceedings, to submit to any examination or assessment required or directed to be carried out in accordance with the rules made under this article , article 55 or article 55A, or to provide the information required by virtue of rules made under article 55A(3)(b), or

(ii) to co-operate with the Committee;

(i) enabling the committee during the course of proceedings, to make such inquiries as it considers appropriate;

(j) enabling the Fitness to Practise Committee, following consideration of a disqualification case, instead of issuing a direction under section 80 of the Medicines Act 1968[^f00054] (disqualification and removal from the Register)—

(i) to agree with the individual , partnership or body corporate that the individual , partnership or body corporate will comply with such undertakings as the Committee considers appropriate (and the rules may include provision with respect to the procedure to be followed where any such undertakings are breached), and

(ii) to dispose of the matter by giving advice or a warning; and

(k) for the award of, and in respect of the assessment of, costs or expenses, and may require the committee to have regard to a person’s ability to pay when considering the making of an award against the person under the rules.

(4) An award of costs may, by leave of the High Court, be enforced in the same manner as an order of the High Court to the same effect.

(5) An award of expenses may, by leave of the Court of Session, be enforced in the same manner as a decree of the Court of Session to the same effect.

(6) The rules under paragraph (1) may make provision—

(a) as to the form which is to be used for any document (and may provide that documents specified in the rules are to be in such form as the Council may determine from time to time); and

(b) for documents or certificates to be sent or received as an electronic communication.

Procedure for the Fitness to Practise Committee and the Appeals Committee

62

(1) For the purposes of proceedings under this Order in England and Wales—

(a) the Fitness to Practise Committee or the Appeals Committee may administer oaths; and

(b) the Fitness to Practise Committee, the Appeals Committee or any party to proceedings before either of those committees may apply for the issue of a witness summons directing a person to attend the proceedings in order to give evidence or to produce a document.

(2) No person may be compelled under any such summons to give any evidence or to produce any document which that person could not be compelled to give or produce on the trial of an action.

(3) Section 36 of the Senior Courts Act 1981[^f00055] (subpoena issued by High Court to run throughout the United Kingdom), which provides a special procedure for the issue of such a summons so as to be in force throughout the United Kingdom, applies in relation to any proceedings under this Order in England and Wales as it applies in relation to causes and matters in the High Court.

(4) For the purposes of any such proceedings in Scotland, the Fitness to Practise Committee or the Appeals Committee may administer oaths and the Court of Session has, on the application of any party to the proceedings, the like power as in any action in that court—

(a) to grant warrant for the citation of witnesses and havers to give evidence or to produce documents before the committee, and for the issue of letters of second diligence against any witness or havers failing to appear after due citation;

(b) to grant warrant for the recovery of documents; and

(c) to grant commissions to persons to take the evidence of witnesses or to examine havers and receive their exhibits and productions.

(5) Where—

(a) several sittings of the Fitness to Practise Committee or the Appeals Committee are required to enable the committee to dispose of the case; or

(b) on an appeal to the relevant court under article 58, the case is remitted to the Fitness to Practise Committee to dispose of the case in accordance with directions given by the court,

the validity of the proceedings on the case before the committee may not be called into question by reason only that members of the committee who were present at a former meeting were not present at a later meeting of the committee or that members present at a later meeting were not present at a former meeting of the committee.

Legal advisers

63

(1) The Council may do either or both of the following—

(a) appoint suitably qualified and experienced barristers, solicitors or advocates to be legal advisers;

(b) make rules which provide for it to enter into arrangements with another person for that person to appoint on behalf of the Council suitably qualified and experienced barristers, solicitors or advocates to be legal advisers.

(2) Legal advisers appointed under this article may not be a member of the Council or of a statutory committee.

(3) Legal advisers appointed under this article may be appointed either generally or for any proceedings or particular class of proceedings and are to hold and vacate office in accordance with the terms of the instrument under which they are appointed.

(4) The Council may make rules as to the functions of legal advisers appointed under this article.

Clinical and other specialist advisers

64

(1) The Council may do either or both of the following in connection with proceedings under this Order—

(a) appoint registered medical practitioners to be clinical advisers;

(b) make rules which provide for it to enter into arrangements with another person for that person to appoint on behalf of the Council registered medical practitioners to be clinical advisers.

(2) The Council may do either or both of the following in connection with proceedings under this Order—

(a) appoint persons to act as specialist advisers on issues on which, in the Council’s opinion, specialist knowledge is required;

(b) make rules which provide for it to enter into arrangements with another person for that person to appoint on behalf of the Council persons to be specialist advisers.

(3) Persons appointed to be—

(a) clinical advisers must have specialist expertise in a particular field or fields; and

(b) specialist advisers must have particular expertise in the speciality for which they are appointed.

(4) If clinical advisers are appointed under paragraph (1), their appointment is for the purpose of giving advice to—

(a) the Investigating Committee or the Fitness to Practise Committee on health related issues under consideration by the committee in the proceedings before it; and

(b) the Council or any of its other committees on health related issues.

(5) If specialist advisers are appointed under paragraph (2), their appointment is for the purpose of giving advice to—

(a) one or more of the statutory committees on issues falling within their speciality which are under consideration by the committee in the course of proceedings before it; and

(b) the Council or any of its other committees on issues falling within their speciality or related to it.

(6) Advisers appointed under this article may not be a member of the Council or of a statutory committee.

(7) Advisers appointed under this article—

(a) may be appointed generally; or

(b) may be appointed for the purpose of any proceedings or particular class of proceedings,

and are to hold and vacate office in accordance with the terms of the instrument under which they are appointed.

(8) The Council may make rules as to the functions of advisers appointed under this article.

PART 8 — Miscellaneous

General fees

65

(1) Subject to paragraph (2), the Council may charge such fees as it may reasonably determine in connection with the exercise of its functions, or the functions of its statutory committees.

(2) No fee may be charged, pursuant to paragraph (1), in connection with the exercise of a function where provision is made elsewhere in this Order for the charging of a fee in connection with the exercise of that function.

Rules

66

(1) Any power to make rules under this Order may be exercised—

(a) so as to make different provision—

(i) with respect to different cases or different classes of cases, or

(ii) in respect of the same case or class of case for different purposes;

(b) in relation to all cases to which the power extends or in relation to those cases subject to specified exceptions; or

(c) so as to make any supplementary, incidental, consequential, transitional, transitory or saving provision as the Council considers necessary or expedient.

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

(3) Before making rules under Parts 3 to 7 of this Order, the Council must consult such persons or organisations as it considers appropriate including—

(a) NHS England in England;

(b) Local Health Boards in Wales;

(d) persons carrying on a retail pharmacy business at a registered pharmacy;

(e) professional bodies or organisations appearing to the Council to represent registrants;

(f) the Professional Standards Authority for Health and Social Care;

(g) such other regulatory bodies as the Council considers relevant; and

(h) other persons, bodies or organisations representing members of the public and patients.

(4) No rules made under this Order, except rules made solely under article 36 (or article 36 together with paragraph (1)), can come into force until approved by order of the Privy Council.

(5) The Privy Council may approve rules submitted to them for approval either in the form submitted to them or subject to such modifications as appear necessary to them.

The Directive: designation of competent authority etc.

67

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Amendments, repeals and revocations

68

The amendments, repeals and revocations contained in Schedule 4 have effect.

Transitional, transitory and saving provisions

69

(1) The transitional provisions contained in Schedule 5 have effect.

(2) The savings contained in Schedule 6 have effect.

(3) In connection with the commencement of any provision of this Order, the Privy Council may by order make such transitional, transitory or saving provisions as it considers appropriate.

(4) The power to make an order under paragraph (3) may be exercised—

(a) so as to make different provision—

(i) with respect to different cases or different classes of cases, or

(ii) in respect of the same case or class of case for different purposes;

(b) in relation to all cases to which the power extends or in relation to all those cases subject to specified exceptions; or

(c) so as to make any supplementary, incidental or consequential provisions which the Privy Council considers necessary or expedient.

Privy Council procedures etc.

70

(1) Any power vested in the Privy Council to make an order under this Order may be exercised by any two or more members of the Privy Council.

(2) Any power of the Privy Council to make an order under this Order is exercisable by statutory instrument and, except for an order made solely in respect of approving rules under article 19, 27, 31 or 36 (or any of those articles together with article 66(1)), an order of the Privy Council under this Order is subject to annulment in pursuance of a resolution of either House of Parliament or of the Scottish Parliament.

(3) Paragraph (2) and article 66(4) do not preclude the inclusion of rules under article 19, 27, 31 or 36 in a set of rules which is to be approved by an order of the Privy Council that is subject to annulment in pursuance of a resolution of either House of Parliament or of the Scottish Parliament.

(4) For the purposes of section 1 of the Statutory Instruments Act 1946[^f00056] (definition of “Statutory Instrument”), any power of the Privy Council to make an order under this Order is to be taken to be conferred by an Act of Parliament.

(5) Any act of the Privy Council under this Order is sufficiently signified by an instrument signed by the Clerk of the Privy Council.

(6) Where an order or act of the Privy Council under this Order 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, or the act duly done; and

(b) the order’s terms.

SCHEDULE 1 — Constitution of the General Pharmaceutical Council

Membership: general

1

(1) The Council is to consist of—

(a) registrant members, that is members who are entered in the Register as a pharmacist or as a pharmacy technician; and

(b) lay members, that is members who—

(i) are not and never have been entered in the register of any regulatory body, and

(ii) do not hold qualifications which would entitle them to apply for registration under this Order.

(2) The members of the Council are to be appointed by the Privy Council.

(3) The Privy Council must ensure that, at any time, at least one of the members of the Council lives or works wholly or mainly in each of England, Scotland and Wales.

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

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

Matters for the order of the Privy Council under article 4(2)

2

(1) An order under article 4(2) must include provision with regard to—

(a) the number of registrant members and lay members of the Council;

(b) the terms of office for which members of the Council are appointed and the order may provide that these are to be determined by the Privy Council, on appointment;

(d) the appointment (from among the members of the Council) of a chair of the Council and the chair’s term of office, and the order may provide that the term is to be determined by whoever makes the appointment as chair, on appointment;

(e) deputising arrangements in respect of the chair;

(f) the appointment of the first Chief Executive Officer of the Council;

(g) the quorum of the Council;

(h) the circumstances in which members cease to hold office or may be removed or suspended from office.

(2) An order under article 4(2) may include provision with regard to—

(a) the maximum period for which a member of the Council may hold office as a member during a specified period;

(b) the maximum period for which a member of the Council may serve as chair of the Council during a specified period;

(c) the education and training of members of the Council, and the order may provide for the Council to include the requirements with regard to education and training of its members in standing orders and for those standing orders to provide for—

(i) education and training to be the responsibility of another body, and

(ii) those requirements to be set and varied by that body from time to time;

(d) the attendance of members of the Council at meetings of the Council.

(3) An order under article 4(2) may make different provision for different cases or different classes of case and may contain such incidental, consequential, transitional, transitory, saving or supplementary provisions as appear to the Privy Council to be necessary or expedient.

Powers of the Council

3

(1) Subject to the following provisions of this Schedule, the Council has power to do anything which is calculated to facilitate the discharge of its functions or which is incidental or conducive to the discharge of its functions.

(2) The Council has, in particular, power—

(a) to borrow;

(b) to institute criminal prosecutions under any enactment;

(d) to establish such sub-committees of any of its committees as it may determine;

(e) subject to any provision made by or under this Order, to regulate the procedure of any of its committees or their sub-committees;

(f) to abolish any of its committees, other than a statutory committee, or to abolish any sub-committee of any of its committees;

(g) to pay its members such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as may be determined by the Privy Council on appointment;

(h) to pay the members of its statutory committees (including co-opted members), the members of any of its other committees and the members of the sub-committees of any of its committees such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as it may reasonably determine;

(i) to pay its staff (including the Registrar and any Deputy Registrar) such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as it may reasonably determine;

(j) to pay such remuneration, allowances or expenses as it may reasonably determine to advisers advising the Council or one of its committees on issues falling within the advisers’ speciality which are under consideration by the Council or committee, including legal advisers appointed under article 63 and clinical and other specialist advisers appointed under article 64.

(3) The powers of the Council may be exercised even though there is a vacancy among its members.

(4) No proceedings of the Council are to be invalidated by any defect in the appointment of a member.

(5) Subject to any provision made by or under this Order, the Council may regulate its own procedure.

Registration of members’ private interests

4

(1) The Council must establish and maintain a system for the declaration and registration of private interests of its members.

(2) The Council must publish in such manner as it sees fit entries recorded in its register of members’ private interests.

The statutory committees

5

(1) The Council must by rules, as regards each of the statutory committees, make provision with regard to—

(a) its size and composition (which may vary according to the functions the committee is performing), but the number of members of the committee who are registrants must not exceed the number of other members on the committee by more than one;

(b) the appointment, performance, suspension and removal from office of its members;

(d) the quorum at its meetings; and

(e) its procedures, including deputising arrangements with regard to its chair.

(2) The provisions with regard to size, composition and procedures of a statutory committee may, except in relation to the Investigating Committee, provide for the chair of the committee to have the power to determine a particular size and composition for the committee for a particular hearing or inquiry before the committee and, in particular, to determine—

(a) that only specified members of the full committee are entitled to sit at the hearing or inquiry and decide the matter to which the hearing or inquiry relates (but the chair or a deputy chair must be one of the specified members); and

(b) a different quorum for the hearing or inquiry and the related meetings of the committee than would otherwise be the case (which must not be less than three),

but where the chair does determine a particular size and composition of the committee for a particular hearing or inquiry, the chair must ensure that the number of registrants who are members of that formation of the committee does not exceed the number of other members by more than one.

(3) Rules under this paragraph may in addition include provision with regard to—

(a) the education and training of members of a statutory committee, and the rules may provide that members are to meet competencies that the Council may determine from time to time;

(b) the attendance of members of a statutory committee;

(i) establish and maintain a system for the declaration and registration of private interests of its members, and

(ii) publish in such manner as it sees fit entries recorded in its register of members’ private interests; and

(d) the functions to be performed by a statutory committee and how it is to perform them.

(4) Rules under this paragraph must provide that—

(a) no person may be both a member of the Council and of the Appeals Committee or the Fitness to Practise Committee;

(b) no person may be both a member of the Investigating Committee and of the Fitness to Practise Committee;

(c) no person who is a member of the Fitness to Practise Committee that has made an interim order under article 56 in proceedings in any case may sit as a member of the Committee in subsequent proceedings in that case, unless the subsequent proceedings relate solely to measures under article 56; and

(d) the appointment, suspension and removal of members, chairs and deputy chairs of the statutory committees must be by the Council, except that the rules may provide for the Council to enter into arrangements with another person, body or committee (including a committee of the Council that is not one of the statutory committees) to carry out all or any of these functions on the Council’s behalf.

(5) Rules under this paragraph may provide for a statutory committee to—

(a) have more than one deputy chair;

(b) co-opt members onto the committee in such circumstances as may be specified in the rules; and

(c) discharge, in such circumstances and subject to such conditions as may be specified in the rules, functions of the Council.

(6) The powers of a statutory committee may be exercised even though there is a vacancy among its members.

(7) No proceedings of a statutory committee are to be invalidated by any defect in the appointment of a member.

(8) In exercising a function under article 54 or 57, the Fitness to Practise Committee must have regard to the over-arching objective of the Council under article 6(1) (read with article 6(1A)).

The Council’s duties in respect of publications

6

(1) The Council must from time to time publish or provide in such manner as it sees fit information about the regulation of pharmacists, pharmacy technicians and registered pharmacies.

(2) The Council may from time to time publish or provide in such manner as it sees fit guidance to registrants, employers and such other persons as it considers appropriate in respect of the standards for the education, training, supervision and performance of persons who are not registrants but who provide services in connection with those provided by registrants.

Accounts

7

(1) The Council must—

(a) keep accounts, which must be in such form as the Privy Council may determine; and

(b) prepare annual accounts in respect of each financial year, which must be in such form and must be prepared by such date as the Privy Council determines.

(2) In sub-paragraph (1), “financial year” means—

(a) the period beginning with the day on which the Council is established and ending with the next 31 March following that day, and

(b) each successive period of 12 months ending with 31 March.

(3) The Council must ensure that a person eligible for appointment as a statutory auditor under Part 42 of the Companies Act 2006[^f00058] (statutory auditors) audits the Council’s annual accounts.

(4) As soon as is reasonably practicable after those accounts have been audited, the Council must—

(a) cause them to be published together with any report made on them by the auditors appointed under sub-paragraph (3); and

(b) send a copy of those annual accounts and of any such report to the Privy Council,

and the Privy Council must lay before each House of Parliament and before the Scottish Parliament a copy of those annual accounts and of any report on the accounts made by the auditors appointed under sub-paragraph (3).

Annual reports, statistical information and strategic plans

8

(1) The Council must publish, by such date in each calendar year as the Privy Council may determine—

(a) a report on the exercise of its functions which includes a description of the arrangements that the Council has put in place to ensure that it adheres to good practice in relation to equality and diversity (and for these purposes “equality” and “diversity” have the meanings given in section 8(2) of the Equality Act 2006[^f00059] (equality and diversity));

(b) a statistical report which indicates the efficiency and effectiveness of, and which includes a description of, the arrangements which the Council has put in place to protect members of the public from registrants whose fitness to practise is impaired, together with the Council’s observations on the report; and

(2) The Council must submit copies of the reports and the plan published under sub-paragraph (1) to the Privy Council and the Privy Council must lay copies of the reports and the plan before each House of Parliament and before the Scottish Parliament.

SCHEDULE 2 — Visiting Practitioners from relevant European States

PART 1 — Pharmacists

Application and interpretation

1

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Registration in respect of provision of occasional pharmacy services

2

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Entitlement to provide occasional pharmacy services: first year

3

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First provision of services: required documents

4

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First provision of services: supplementary

5

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Entitlement to provide occasional pharmacy services after the first year: renewals

6

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Duration of entitlement to provide occasional pharmacy services

7

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Conditions

8

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PART 2 — Pharmacy technicians

Application and interpretation

9

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Registration in respect of the provision of occasional services

10

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Entitlement to provide occasional pharmacy services: first year

11

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First provision of services: required documents

12

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First provision of services: supplementary

13

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Entitlement to provide occasional pharmacy services after the first year: renewals

14

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Duration of entitlement to provide occasional pharmacy services

15

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Conditions

16

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SCHEDULE 3 — The Directive: Designation of competent authority etc.

Provision of Directive	Function of Council
Article 4a	Ensuring that the holder of a European professional card benefits from all of the rights conferred by articles 4b to 4e of the Directive.Charging reasonable fees to cover the costs of processing applications for or in relation to European professional cards under Schedule 2A and under Part 4 of the General Systems Regulations.
Article 4b	Enabling pharmacists to apply for a European professional card in accordance with Schedule 2A and in accordance with Part 4 of the General Systems Regulations.
Article 4c	Verifying the application and supporting documents in the IMI file and issuing the European professional card for pharmacists for the temporary and occasional provision of pharmacy services other than those covered by article 7(4) of the Directive.
Article 4d	Verifying the authenticity and validity of the application and supporting documents in the IMI file for the purpose of issuing the European professional card for pharmacists for establishment or for the temporary and occasional provision of pharmacy services under article 7(4) of the Directive.
Article 4e	Updating, in a timely manner, the IMI file of a holder of a European professional card with information about disciplinary actions or criminal sanctions regarding a prohibition or restriction and which have consequences for the pursuit of any professional activities by that person under the Directive.
Article 4f	Considering applications for partial access to the professions of pharmacist and pharmacy technician under regulations 10 and 11 of the General Systems Regulations.
Article 7(2)(b)	Issuing certificates containing attestations in relation to persons established as pharmacists and pharmacy technicians in Great Britain.
Article 7(2a)	Requesting information from, and providing information to, other competent authorities in accordance with the declaration provided by the applicant to provide pharmacy services on a temporary and occasional basis.
Article 8(1)	In the event of justified doubts, receiving information from, or providing information to, other competent authorities in relation to—the legality of a person’s establishment as a pharmacist or pharmacy technician;the good conduct of such a person;the absence of any disciplinary or criminal sanctions of a professional nature against such a person. Receiving information from, or providing information to, other competent authorities in relation to a person's training courses to the extent necessary to assess substantial differences likely to be harmful to public health and safety.
Article 8(2)	Receiving information from, or providing information to, other competent authorities in connection with the investigation of complaints made against persons providing services as a pharmacist or pharmacy technician.
Article 23(1)	Issuing certificates of effective and lawful practice in Great Britain to pharmacists and pharmacy technicians.
Article 23(6)	Issuing certificates stating that GB pharmacy qualifications, which do not correspond to the titles set out in respect of the United Kingdom at point 5.6.2 of Annex V to the Directive, certify successful completion of training in pharmacy that is in accordance with article 44 of the Directive or that under article 22(a) of the Directive (part-time training) is to be treated as in accordance with article 44 of the Directive.
Article 50(1) and paragraph 1(b) of Annex VII	Providing information to other competent authorities concerning the training in Great Britain of a pharmacist or pharmacy technician to whom Chapter 1 of Part 3 of the General Systems Regulations applies.
Article 50(1) and paragraph 1(d) of Annex VII	Issuing, in respect of practice as a pharmacist or pharmacy technician, the certificates of current professional status referred to in sub-paragraph (d) of paragraph 1 of Annex VII to the Directive within the time limits set by that sub-paragraph.
Article 50(1) and paragraph 2 of Annex VII	Issuing certificates stating that evidence of GB pharmacy qualifications is that covered by the Directive.
Article 50(2)	In cases of justified doubts—requiring confirmation of the authenticity of non-UK pharmacy qualifications;requiring confirmation that holders of non-UK pharmacy qualifications satisfy the minimum training conditions set out in article 44 of the Directive or under article 22(a) of the Directive are to be treated as satisfying those conditions;providing confirmation to competent authorities of other relevant European States of the authenticity of any person’s GB pharmacy qualifications;providing confirmation that holders of GB pharmacy qualifications satisfy the minimum training conditions set out in article 44 of the Directive or under article 22(a) of the Directive are to be treated as satisfying those conditions.
Article 50(3)	In cases of justified doubts—verifying information provided in connection with non-UK pharmacy qualifications awarded following training in a relevant European State other than the State in which the qualification was awarded;providing information in connection with a person’s GB pharmacy qualifications awarded following training in another relevant European State.
Article 50(3a)	In the event of justified doubts, seeking confirmation from, or providing confirmation to, other competent authorities of the fact that the applicant is not suspended or prohibited from the pursuit of the profession of pharmacist or pharmacy technician as a result of serious professional misconduct or conviction of criminal offences relating to the pursuit of any of the applicant's professional activities.
Article 50(3b)	Ensuring that the exchange of information under article 50 of the Directive with other competent authorities takes place through the IMI.
Article 53	Ensuring that any language controls imposed on a pharmacist or pharmacy technician are compliant with article 53 of the Directive.
Article 55a	When considering an application for registration as a pharmacist or as a pharmacy technician, ensuring that in respect of professional traineeships—traineeships undertaken in a relevant European State are recognised in accordance with published guidelines;traineeships undertaken in a third country are taken into account.
Article 56(1)	Ensuring the confidentiality of information exchanged with other competent authorities.
Article 56(2)	Receiving information from, or providing information to, other competent authorities regarding disciplinary action, criminal sanctions or other serious circumstances likely to have consequences for the practice of the profession of pharmacist or pharmacy technician.
	Where such information is received by the Council—examining the veracity of the circumstances;deciding the nature and scope of any investigations that need to be carried out;informing other competent authorities of the Council’s conclusions. Ensuring that the processing of personal data for the purposes of the exchange of information in accordance article 56(2) of the Directive is carried out in accordance with the GDPR and Directive 2002/58/EC and through the IMI.
Article 56(2a)	Ensuring that the exchange of information carried out in accordance with article 56(2) of the Directive takes place through the IMI.
Article 56a(1) and (2)	Informing all other competent authorities, by way of an alert through the IMI, about a pharmacist or a pharmacy technician whose professional activities have been restricted or prohibited, even temporarily, within three days from the date of adoption of the decision; ensuring the information provided is limited to the information referred to in article 56a(2) of the Directive.
Article 56a(3)	Informing all other competent authorities, by way of an alert through the IMI, about the identity of professionals who have applied for registration and who have been subsequently found to have used falsified evidence of professional qualifications, within three days from the date of the finding.
Article 56a(4)	Ensuring that the processing of personal data for the purposes of the exchange of information under article 56a(1) and (3) of the Directive is carried out in accordance with the GDPR and Directive 2002/58/EC.
Article 56a(5)	Informing all other competent authorities through the IMI without delay when—(a) a prohibition or a restriction referred to in article 56a(1) of the Directive has expired;(b) there is a change to the prohibition or restriction period notified under article 56a(2) of the Directive.
Article 56a(6)	Notifying the pharmacist or pharmacy technician, in respect of whom an alert is sent under article 56a(1) or (3) of the Directive, in writing at the same time as the alert is sent, that the pharmacist or pharmacy technician—(a) is the subject of an alert sent under article 56a(1) or (3) of the Directive;(b) has the right to appeal the decision or to apply for rectification of the decision;(c) has the right to access remedies in respect of any damage caused by false alerts sent to other competent authorities.
	Informing competent authorities, where applicable, that an alert is subject to appeal proceedings by the pharmacist or pharmacy technician.
Article 56a(7)	Ensuring that an alert made under article 56a(1) of the Directive is deleted from the IMI within three days of—(a) the date of adoption of the revoking decision; or(b) the expiry of the prohibition or restriction referred to in that article.
Article 57a(1)	Ensuring that all requirements, procedures and formalities relating to the recognition of qualifications as a pharmacist or a pharmacy technician may be easily completed by the applicant remotely and by electronic means.

SCHEDULE 4 — Amendments, repeals and revocations

PART 1 — Primary legislation

Amendment of the Medicines Act 1968

1

(1) The Medicines Act 1968[^f00060] is amended as follows.

(2) In section 69[^f00061] (general provisions for Part 4)—

(a) in subsection (1ZA), for “registered in Part 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007 (visiting pharmacists from relevant European States)” substitute “registered in Part 4 of the register maintained under article 19 of the Pharmacy Order 2010 (visiting pharmacists from relevant European States)”;

(b) in subsection (3)—

(i) omit the definition of “the Council”,

(ii) insert, in the appropriate place, the following definition—

“the register” means— in relation to Great Britain, the register established and maintained under article 19 of the Pharmacy Order 2010; and in relation to Northern Ireland, the register kept for the purposes of section 75;

(iii) for the definition of “the registrar”, substitute—

“the registrar” means— 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 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;

, and

(iv) for the definition of “the relevant disciplinary committee” substitute—

“the relevant disciplinary committee” means— in relation to Great Britain, the Fitness to Practise Committee established under article 4(6) of the Pharmacy Order 2010; and in relation to Northern Ireland, the Statutory Committee appointed under Article 19 of the Pharmacy (Northern Ireland) Order 1976;

(3) In section 70[^f00062] (business carried on by individual pharmacist or by partners)—

(a) in subsection (3), for paragraph (b) substitute—

(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

(b) in subsection (4), for paragraph (b) substitute—

(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

(5) In relation to premises in Great Britain that have been registered pharmacies for less than three years, the responsible pharmacist may not be a person who is a pharmacist by virtue of a qualification in pharmacy awarded in a relevant European State. (6) Subsection (5) does not apply to premises entered in the register by virtue of section 74J.

(4) In section 71[^f00063] (business carried on by body corporate)—

(a) in subsection (3), for paragraph (b) substitute—

(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

(b) for subsection (5) substitute—

(5) In relation to premises in Great Britain that have been registered pharmacies for less than three years, the responsible pharmacist may not be a person who is a pharmacist by virtue of a qualification in pharmacy awarded in a relevant European State. (5A) Subsection (5) does not apply to premises entered in the register by virtue of section 74J.

(7) In subsection (6)(a) “pharmacist”— (a) does not include a person registered in Part 4 of the register maintained under article 19 of the Pharmacy Order 2010 (visiting pharmacists from relevant European States) unless the retail pharmacy business under the management of the person is carried on (in whole or in part) at premises entered in the register by virtue of section 74J; and (b) does not include a person registered in the register of visiting pharmaceutical chemists from relevant European States maintained under Article 9 of the Pharmacy (Northern Ireland) Order 1976.

; and

(d) after subsection (7), insert—

(8) If a person who has managed a relevant retail pharmacy business as a superintendent ceases to do so (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 manage the business. (9) For the purposes of subsection (8), a “relevant retail pharmacy business” is a retail pharmacy business carried on (in whole or in part) at premises in Great Britain.

(5) In section 72[^f00064] (representative of a pharmacist in case of death or disability) for paragraph (b) of subsection (2B) substitute—

(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

(6) In subsection 72B[^f00065] (section 72A: supplementary), for subsection (1) substitute—

(1) The failure by a person to comply with any requirements of section 72A of this Act, or of regulations made under that section, 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.

(7) In section 74[^f00066] (meaning of “registered pharmacy”)—

(a) in subsection (1), omit “required to be kept under section 75 of this Act”;

(b) after subsection (1) insert—

(1A) If the entry of a registered pharmacy in the register is suspended under paragraph (4)(b) of article 14 of the Pharmacy Order 2010 then, except for such purposes of that Order as the General Pharmaceutical Council may prescribe by rules, that registered pharmacy must be treated as not being entered in the register notwithstanding that the register still includes the address of that pharmacy. (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 apart from that Order.

; and

(8) After section 74 insert—

(74A) (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. (74B) (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 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 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 provided for in rules made 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 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 provided for in rules made under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at the premises, and (ii) that the requirements of rules made under article 7(4) of that Order are met by the person carrying on a retail pharmacy business at the premises. (74C) (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 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 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. (74D) 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 the premises and of the date from which that condition, variation or revocation is to have effect. (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 at 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, (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 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. (74E) (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 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 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. (74F) (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 the premises, or at 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). (74G) (1) An application may be made to the registrar by the person carrying on a retail pharmacy business at 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. (74H) (1) Subject to subsection (2), where a change occurs in the ownership of a retail pharmacy business carried on at 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 the premises. (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 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 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 provided for in rules made under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at 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 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. (74I) (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 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. (74J) with regard to the emergency. (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, (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 at 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 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. (74K) (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. (74L) 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.

(9) In section 75[^f00067] (registration of premises)—

(a) in the heading, after “premises” insert “: Northern Ireland”;

(b) before subsection (1), insert—

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

(d) in subsection (8), omit—

(i) paragraphs (a) and (b),

(ii) “and” at the end of paragraph (b), and

(iii) “in relation to premises in Northern Ireland,” in paragraph (c).

(10) In section 76[^f00068] (supplementary provisions as to the registration of premises)—

(a) in the heading, after “premises” insert “: Northern Ireland”;

(b) in subsection (1), after “entered in the register” insert “under section 75”;

(i) after “entered in the register” insert “under section 75”,

(ii) for “the Council” wherever those words occur, substitute “the appropriate Minister”,

(iii) in paragraph (b), for “direct” substitute “directs”,

(d) in subsection (7), insert “in Northern Ireland” after “specified premises”;

(e) omit subsection (8);

(f) for subsection (9), substitute—

(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.

(11) In section 77[^f00069] (annual return of premises to the registrar)—

(a) after “carries on a retail pharmacy business” insert “at premises in Northern Ireland”;

(b) in paragraph (a), before “premises” insert “such”.

(12) In section 78[^f00070] (restrictions on use of titles, descriptions and emblems), for subsection (5) substitute—

(5) A person who is not registered in the register of pharmaceutical chemists for Northern Ireland or in the register of visiting pharmaceutical chemists from a relevant European State 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 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 or 4 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 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.

(13) In section 79[^f00071] (provision for modifying or extending restrictions under section 78), in subsection (3), for “the Council” substitute “the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland”.

(14) In section 80[^f00072] (power for relevant disciplinary committee to disqualify and direct removal from register)—

(a) for subsection (1) substitute—

(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 in Great Britain that are entered in the register as premises at which the body corporate carries on that business, there is a failure to meet the standards that are provided for in rules made under article 7(1) of the Pharmacy Order 2010 in connection with the carrying on of the business at 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.

; and

(b) in subsection (5), for the words from “the Pharmacy Act 1954” to “the Misuse of Drugs Act 1971” substitute “the 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”.

(15) In section 81[^f00073] (grounds for disqualification in certain cases)—

(a) for subsection (1) substitute—

(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.

(b) in subsection (2)—

(i) for “The facts referred to in subsection (1)(a) of this section are” substitute “The facts referred to in subsection (1A)(a) of this section are”,

(ii) in sub-paragraph (a), for “the offence or misconduct in question” substitute “the offence, misconduct or failure in question”,

(iii) for sub-paragraph (b) substitute—

(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;

, and

(iv) in sub-paragraph (d), for “offence or misconduct in question is a continuing offence or continuing misconduct” substitute “offence, misconduct or failure in question is a continuing offence or failure or is continuing misconduct”.

(16) After section 84 (offences under Part 4) insert the following section—

(84A) (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 Part 4 of this Act 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).

(17) In section 108[^f00074] (enforcement in England and Wales), in subsection (6)(c), for “sections 77 and 78” substitute “section 78”.

(18) In section 132(1)[^f00075] (general interpretation provisions)—

(a) in the definition of “Pharmaceutical Society”, for “the Pharmaceutical Society of Great Britain” substitute “the General Pharmaceutical Council”; and

(b) in the definition of “pharmacist”, for “a person registered in Part 1 or 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “a person registered as a pharmacist in the register maintained under article 19 of the Pharmacy Order 2010”.

(19) In section 136 (short title, extent and commencement), for subsection (2) substitute—

(2) Except as provided by section 78(5B), this Act extends to Northern Ireland.

Amendment of the Poisons Act 1972

2

(1) The Poisons Act 1972[^f00076] is amended as follows.

(2) In section 9 (inspection and enforcement)—

(a) omit subsections (1) to (3);

(b) in subsection (4)—

(i) for “the Society under this section” substitute “the General Pharmaceutical Council under article 8(1) of the Pharmacy Order 2010”,

(ii) for paragraph (a) substitute—

(a) shall, for the purpose of securing compliance by pharmacists and persons carrying on a retail pharmacy business with the preceding provisions of this Act and with the Poisons Rules, have power at all reasonable times to enter any registered pharmacy, and

(iii) in paragraph (b)—

(aa) for “other persons” substitute “persons other than pharmacists and persons carrying on a retail pharmacy business”, and

(bb) omit “in either case”;

(d) after subsection (5) insert—

(5A) A local authority may, with the consent of the General Pharmaceutical Council, appoint an inspector appointed by the General Pharmaceutical Council under article 8(1) of the Pharmacy Order 2010 to be also an inspector for the purposes of subsection (5).

(3) In section 11(2) (interpretation), for the definition of “pharmacist” substitute—

“pharmacist” means a person registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners);

Amendment of the Race Relations Act 1976

3

In Part 2 of Schedule 1A to the Race Relations Act 1976[^f00077] (bodies and other persons subject to general statutory duty), under the heading “Regulatory, audit and inspection”—

(a) at the appropriate place insert “The General Pharmaceutical Council.”; and

(b) omit “The Royal Pharmaceutical Society of Great Britain, in respect of its statutory functions and the regulation of the pharmacy profession.”.

Amendment of the National Health Service (Scotland) Act 1978

4

(1) The National Health Service (Scotland) Act 1978[^f00078] is amended as follows.

(2) In section 27[^f00079] (arrangements for the provision of pharmaceutical services), in subsection (4)(ba), for “in the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007 by virtue of a qualification in pharmacy awarded in an EEA State other than the United Kingdom, or in Switzerland”, substitute “in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010 by virtue of a qualification in pharmacy awarded in an EEA State other than the United Kingdom, or in Switzerland”.

(3) In section 28[^f00080] (persons authorised to provide pharmaceutical services), for subsection (2C) substitute—

(2C) Where— (a) arrangements have been made under this Part with a registered pharmacist; and (b) the registration of that pharmacist is suspended by virtue of any direction or order under the Pharmacy Order 2010, that pharmacist must not provide any services under those arrangements during the period of suspension.

(4) In section 108[^f00081] (interpretation and construction), in subsection (1), for the definition of “registered pharmacist” substitute—

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