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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(ii) with whom the registrant has arrangements to provide such services;

(b) notify the Secretary of State, the Scottish Ministers and the Welsh Ministers of the investigation of the registrant’s fitness to practise;

(c) notify the Department of Health, Social Services and Public Safety in Northern Ireland of the investigation of the registrant’s fitness to practise where the registrant is also entered in the register of pharmaceutical chemists for Northern Ireland or the register of visiting pharmaceutical chemists made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976⁴¹; and

(d) notify any person of whom the Registrar is aware—

(i) by whom the registrant is employed or engaged to provide services in, or in relation to, any area of pharmacy, or

(ii) with whom the registrant has arrangements to provide such services,

of the investigation of the registrant’s fitness to practise.

(6) Where a registrant fails to comply with a requirement imposed under paragraph (5)(a) within 14 days of the requirement being imposed, or within such longer period as the Registrar may in the circumstances of the particular case allow—

(a) the failure may be treated as misconduct for the purposes of article 51(1)(a) and the Registrar may refer the matter to the Committee that is considering the allegation in respect of the registrant; and

(b) the Registrar may seek an order of the relevant court requiring the requested details to be supplied.

(7) For the purposes of this article, the “relevant court” means—

(a) in a case where the registrant is domiciled in Scotland, the sheriff in whose sheriffdom that registrant is domiciled; and

(b) in any other case, the county court (the Central London County Court if the registrant is not domiciled in Great Britain).

Consideration by the Investigating Committee

53

(1) Where an allegation or a matter (referred to in this article as “the allegation”) is referred to the Investigating Committee by—

(a) the Registrar under article 52(1) or (6)(a); or

(b) an individual assessor or an assessment team under rules made under article 55(3)(c),

the Committee must decide whether the allegation ought to be considered by the Fitness to Practise Committee.

(2) If the Investigating Committee decides that the allegation need not be considered by the Fitness to Practise Committee, then unless the person who is the subject of the allegation (referred to in this article as “the person concerned”) has requested a referral under paragraph (3)—

(a) the Investigating Committee may give—

(i) a warning to the person concerned in connection with any matter arising out of or related to the allegation and give a direction that details of the warning be recorded in the Register,

(ii) advice to the person concerned in connection with any matter arising out of, or related to, the allegation, and

(iii) advice to any other person or other body involved in its investigation of the allegation on any issue arising out of, or related to, the allegation; and

(b) the Registrar must inform the person concerned and the person who made the allegation, if any, of the Investigating Committee’s decision and any action it is taking under sub-paragraph (a).

(2A) In deciding whether to give a warning or advice under paragraph (2), the Investigating Committee must have regard to the over-arching objective of the Council under article 6(1) (read with article 6(1A)).

(3) If the Investigating Committee determines that the allegation ought to be considered by the Fitness to Practise Committee or the person concerned has requested a referral under this paragraph—

(a) the Investigating Committee must refer the allegation to the Fitness to Practise Committee;

(b) where the Investigating Committee considers that the Fitness to Practise Committee should consider making an interim order under article 56, it must notify the Fitness to Practise Committee accordingly; and

(c) the Registrar must inform the person concerned and the person who made the allegation, if any, of the Investigating Committee’s decision to refer the allegation to the Fitness to Practise Committee.

(4) If, having considered the allegation, the Investigating Committee considers that the Council should consider exercising any of its powers to bring criminal proceedings under any enactment, it must notify the Registrar accordingly.

Consideration by the Fitness to Practise Committee

54

(1) Where an allegation or matter (referred to in this article as “the allegation”) is referred to the Fitness to Practise Committee by the Registrar—

(a) under rules made by virtue of article 52(2)(b);

(b) under article 52(6)(a);

(d) by an individual assessor or an assessment team under rules made under article 55(3)(c),

the Fitness to Practise Committee must determine whether or not the fitness to practise of the person in respect of whom the allegation is made (referred to in this article as “the person concerned”) is impaired.

(2) If the Fitness to Practise Committee determines that the fitness to practise of the person concerned is impaired, it may—

(a) give a warning to the person concerned in connection with any matter arising out of, or related to, the allegation and give a direction that details of the warning be recorded in the Register;

(b) give advice to any other person or other body involved in the investigation of the allegation on any issue arising out of, or related to, the allegation;

(d) give a direction that the entry in the Register of the person concerned be suspended, for such period not exceeding 12 months as may be specified in the direction; or

(e) give a direction that the entry in the Register of the person concerned be conditional upon that person complying, during such period not exceeding 3 years as may be specified in the direction, with such requirements specified in the direction as the Committee thinks fit to impose for the protection of the public or otherwise in the public interest or in the interests of the person concerned.

(3) Where the Fitness to Practise Committee has given a direction under this article, other than a direction that the entry in the Register of the person concerned be removed, it may, if it thinks fit, following a review—

(a) where the entry in the Register of the person concerned is suspended, give a direction that—

(i) the entry be removed from the Register,

(ii) the suspension of the entry be extended for such further period not exceeding 12 months as may be specified in the direction, starting from the time when the period of suspension would otherwise expire,

(iii) the entry be suspended indefinitely, if the suspension has already been in force throughout a period of at least two years,

(iv) in the case of an indefinite suspension, terminate the suspension, provided that the review takes place in the circumstances provided for in paragraph (4), or

(v) on expiry or termination of the period of suspension (including a period of suspension that was expressed to be indefinite), the entry be conditional upon that person complying, during such period not exceeding 3 years as may be specified in the direction, with such requirements specified in the direction as the Committee thinks fit to impose for the protection of the public or otherwise in the public interest or in the interests of the person concerned;

(b) where the entry in the Register of the person concerned is conditional upon that person complying with requirements specified in a direction given under this article, give a direction that—

(i) the period specified in the direction for complying with the requirements be extended for such further period not exceeding 3 years as may be specified in the direction, starting from the time when the earlier period would otherwise expire,

(ii) the requirements be added to, removed or otherwise varied in such manner as may be specified in the direction,

(iii) the entry instead be suspended (for example, where that person has failed, whether wholly or partly, to comply with the requirements), for such period not exceeding 12 months as may be specified in the direction, or

(iv) the entry be removed from the Register, if that person has failed, whether wholly or partly, to comply with the requirements.

(4) If the Fitness to Practise Committee gives a direction under paragraph (3)(a)(iii), the Committee must review the direction if—

(a) the person concerned asks it to do so; and

(b) at least two years have elapsed—

(i) since the direction took effect, or

(ii) if the direction has already been reviewed by the Committee, since the conclusion of the last review by the Committee.

(5) If the Fitness to Practise Committee determines that the fitness to practise of the person concerned is not impaired—

(a) the Committee may give—

(i) a warning to the person concerned in connection with any matter that the Committee considers necessary or desirable taking into account the Committee’s findings and give a direction that details of the warning be recorded in the Register,

(ii) advice to the person concerned in connection with any such matter, and

(iii) advice to any other person or other body involved in the investigation of the allegation on any issue arising out of, or related to, the allegation;

(b) the Registrar must inform the person concerned and the person who made the allegation, if any, of the Committee’s decision and any action it is taking under sub-paragraph (a); and

(c) the Committee must, if the person concerned so requests, publish in such manner as it sees fit a statement summarising its determination, or may publish such a statement if that person consents.

(6) If the person concerned is entered in more than one part of the Register, the Fitness to Practise Committee—

(a) must make separate determinations under this article in relation to each part of the Register; and

(b) may give a direction under paragraph (2) or (3) in relation to only one part of the Register or different directions in relation to different parts of the Register,

but may otherwise deal with the matter as a single case.

(7) If the Fitness to Practise Committee determines under this article that a person’s fitness to practise is impaired solely by reason of adverse physical or mental health, it may not give a direction under paragraph (2)(c), (3)(a)(i) or (3)(b)(iv) that the entry in the Register in respect of that person be removed.

(8) If the Fitness to Practise Committee gives a warning or a direction under this article, the Registrar must on its behalf send to the person concerned at the last known home address of that person a statement in writing giving the person notice of the reasons for the warning or the direction and of any right of appeal under article 58.

(9) If, having considered the allegation, the Fitness to Practise Committee considers that the Council should consider exercising any of its powers to bring criminal proceedings under any enactment, it must notify the Registrar accordingly.

Professional performance assessments

55

(1) The Council may make rules about the circumstances in which the Registrar, the Investigating Committee and the Fitness to Practise Committee are authorised to give directions requiring an assessment of the standard of a registrant’s professional performance by an individual assessor or an assessment team.

(1A) In this article, a reference to the standard of a registrant’s professional performance includes the standard of the registrant’s knowledge of English and, in particular, whether the registrant has the necessary knowledge of English.

(1B) But an assessment carried out by virtue of this article must not be limited to an assessment of whether a registrant has the necessary knowledge of English.

(1C) Where an assessment is required to be undertaken by virtue of article 55A, that assessment must not be carried out by an assessment team.

(2) The circumstances that may be prescribed under paragraph (1) include circumstances arising during proceedings of either Committee.

(3) The Council may make such provision as it considers appropriate in rules in connection with the composition of assessment teams and the functions of and procedures to be followed by individual assessors and assessment teams and may, in particular, make provision with regard to—

(a) the Council entering into arrangements with other bodies for those bodies to provide individual assessors or assessment teams to carry out the assessments;

(b) allowing an assessment by an individual assessor or an assessment team to include an assessment of the standard of a registrant’s professional performance both at any time before the assessment and at the time of the assessment; and

(c) referring to the Investigating Committee or the Fitness to Practise Committee a case where an individual assessor or an assessment team considers that a registrant has failed to comply with a reasonable requirement that has been imposed on that registrant by the individual assessor or the assessment team.

(4) An individual assessor or an assessment team, in connection with carrying out an assessment of the standard of a registrant’s professional performance—

(a) may require the production of, and inspect and take copies of, any records (in whatever form they are held) arising out of or related to the registrant’s professional practice; and

(b) where such records are kept otherwise than in legible form, may require a copy of them to be given in legible form.

(5) Nothing in, or in rules under, this article requires or permits—

(a) any disclosure of information which is prohibited by or under any enactment or the UK GDPR, but where that prohibition arises because the information is in a form which allows for the identification of an individual, an individual assessor or an assessment team, when requiring the production of records under paragraph (4)(a), may require that the records be put in a form which does not allow for the identification of that individual; or

(b) the production of records which a person could not be compelled to produce in civil proceedings in the High Court or the Court of Session under article 58.

(6) In determining for the purposes of paragraph (5)(a) whether a disclosure is prohibited, it is to be assumed for the purposes of paragraph 5(2) of Schedule 2 to the Data Protection Act 2018 and paragraph 3(2) of Schedule 11 to that Act (exemptions from certain provisions of the data protection legislation: disclosures required by law) that the disclosure is required by paragraph (4) of this article.

(7) If a person fails to produce any records within 14 days of being required to do so under paragraph (4), the Registrar, the Investigating Committee or the Fitness to Practise Committee on whose behalf the individual assessor or assessment team is carrying out the assessment in connection with which the records are being sought, may seek an order of the relevant court requiring the records to be produced.

(8) For the purposes of this article, the “relevant court” means—

(a) in a case where records are being sought in relation to a registrant who is domiciled in Scotland, the sheriff in whose sheriffdom that registrant is domiciled; and

(b) in any other case, the county court (the Central London County Court in the case of a registrant who is not domiciled in Great Britain).

(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interim orders

56

(1) Where the Fitness to Practise Committee is satisfied that it is necessary for the protection of members of the public or is otherwise in the public interest or is in the interests of the registrant for an entry in the Register relating to a registrant to be suspended or to be made subject to conditions, the Committee may make an order—

(a) that the entry in question be suspended for such period not exceeding 18 months as may be specified in the order ...; or

(b) that the entry in question be conditional upon the registrant complying, during such period not exceeding 18 months as may be specified in the order, with such requirements specified in the order as the Committee thinks fit to impose (an “order for interim conditional entry”).

(1A) Where, during an inquiry under section 80(1) or (1A) of the Medicines Act 1968, the Fitness to Practise Committee is satisfied that it is necessary for the protection of the public or is otherwise in the public interest to suspend one or more of the entries in Part 3 of the register relating to a person carrying on a retail pharmacy business (“a pharmacy owner”), the Committee may make an order that the entry (or entries) in question be suspended for such period not exceeding 18 months as may be specified in the order.

(1B) In this article, an “interim suspension order” means an order under paragraph (1)(a) or (1A).

(2) Subject to paragraph (7), where the Fitness to Practise Committee has made an order under paragraph (1) or (1A), the Committee—

(a) must review it within the period of 6 months beginning with the date on which the order was made, and must after that, for so long as the order continues in force, further review it—

(i) before the end of the period of 6 months beginning with the date of the decision of the immediately preceding review, or

(ii) if, after the end of the period of 3 months beginning with the date of the decision of the immediately preceding review, the registrant or pharmacy owner concerned requests an earlier review, as soon as practicable after that request; and

(b) may review it where new evidence relevant to the order has become available after it was made.

(3) Where an interim suspension order or an order for interim conditional entry has been made in relation to any registrant or pharmacy owner under any provision of this article (including this paragraph) the Fitness to Practise Committee may—

(a) revoke the order;

(b) add to, remove or otherwise vary any condition imposed by the order; or

(c) as regards a registrant, if satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest—

(i) replace an order for interim conditional entry with an interim suspension order having effect for the remainder of the term of the previous order, or

(ii) replace an interim suspension order with an order for interim conditional entry having effect for the remainder of the term of the previous order.

(4) If an order is made, revoked or varied under any provision of this article, the Registrar must without delay send to the registrant or pharmacy owner in respect of whose entry in the Register it relates at the last known home address of that person , or in the case of pharmacy owner that is a partnership or body corporate at the address of its registered or principal office, a statement in writing giving the registrant or pharmacy owner notice of the order, the revocation or, as the case may be, the variation.

(5) The Council may apply to the relevant court for an order made by the Fitness to Practise Committee under paragraph (1) , (1A) or (3) to be extended or, if it has been extended, further extended, and on such application the relevant court may extend, or further extend, for up to 12 months the period for which the order has effect.

(6) Any reference in this article to an interim suspension order, or to an order for interim conditional entry, includes a reference to such an order as extended under paragraph (5).

(7) For the purposes of paragraph (2), the first review after the relevant court’s extension of an order made by the Fitness to Practise Committee, or after a replacement order made by the Fitness to Practise Committee under paragraph (3)(c), must take place—

(a) if the order (or the order which has been replaced) has not been reviewed at all under paragraph (2), within the period of 6 months beginning with the date on which the relevant court ordered the extension or on which the replacement order under paragraph (3)(c) was made; and

(b) if the order (or the order which has been replaced) has been reviewed under paragraph (2), within the period of 3 months beginning with that date.

(8) A registrant or pharmacy owner who is aggrieved by the decision of the Fitness to Practise Committee to make or vary an order under this article may appeal against that decision to the relevant court, and the court may—

(a) in the case of an interim suspension order, terminate the suspension;

(b) in the case of an order for interim conditional entry, revoke the order or remove or vary any condition imposed by the order; and

(c) in either case, substitute for the period specified in the order (or in the order extending it) some other period which could have been specified in the order when it was made (or in the order extending it),

but unless the court otherwise directs, the order remains in force pending the outcome of the appeal.

(9) The decision of the relevant court on any application under paragraph (8) is final.

(10) If an order is made in relation to a registrant under this article and that order remains in effect immediately before the determination in respect of the allegation against the registrant under article 54(1), the Fitness to Practise Committee must revoke the order once it has been determined whether or not the registrant’s fitness to practise is impaired.

(10A) At the conclusion of an inquiry under section 80(1) or (1A) of the Medicines Act 1968, if an interim suspension order remains in effect in relation to the pharmacy owner who was the subject of the inquiry, the Fitness to Practise Committee must revoke the order whether or not a direction is given in relation to the pharmacy owner under that section.

(11) In this article, “the relevant court” means—

(a) in a case relating to a registrant who is domiciled in Scotland, the Court of Session; and

(b) in any other case, the High Court.

Restoration of names to the Register: fitness to practise

57

(1) Subject to paragraph (2)—

(a) a person whose entry has been removed from one or more parts of the Register, in accordance with a direction under article 54(2)(c) or (3)(a)(i) or (b)(iv) may apply to the Registrar under this article for restoration to any part of the Register from which that person’s entry has been removed; and

(b) the Registrar must refer that application to the Fitness to Practise Committee.

(2) An application may not be made under paragraph (1)—

(a) before the expiration of five years from the date of removal; or

(b) within 12 months of the date of an earlier application under paragraph (1) relating to the same entry.

(3) The Council may make such provision in rules in connection with applications for restoration by virtue of paragraph (1) as it considers appropriate and may, in particular, make provision with regard to—

(a) the form and manner in which applications for restoration 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) the information to be provided by the applicant, including—

(i) the name under which the applicant intends to practise, and

(ii) the applicant’s home address;

(c) whether any, and if so what, additional education, training or continuing professional development is required before restoration (and the rules may make provision for these issues to be determined in individual cases by the Registrar);

(d) fitness to practise matters; and

(e) refusal of applications (including where the applicant has not paid the fee prescribed under article 36(1)(b)).

(4) An application under this article may not be granted unless the person applying for restoration provides such evidence of fitness to practise as the Fitness to Practise Committee directs.

(5) Where the Fitness to Practise Committee refuses an application for restoration, the Registrar must send to the applicant at the applicant’s last known home address a statement in writing giving the applicant notice of the decision and of the reasons for it.

(6) If the Fitness to Practise Committee grants the application, it may give a direction that the person’s entry in the part or parts of the Register to which it has been restored be conditional upon that person complying, during such period not exceeding 3 years as may be specified in the direction, with such requirements specified in the direction as the Committee thinks fit to impose for the protection of the public or otherwise in the public interest or in the interests of the person concerned.

(7) Where the Fitness to Practise Committee gives a direction under paragraph (6), that direction must, for the purposes of article 54(3), be treated as a direction under article 54.

(8) If the application under this article relates to more than one part of the Register, the Fitness to Practise Committee—

(a) must make separate determinations under this article in relation to each part of the Register; and

(b) may give a direction under paragraph (6) in relation to only one part of the Register or different directions in relation to different parts of the Register,

but may otherwise deal with the matter as a single case.

(9) If—

(a) the Fitness to Practise Committee refuses an application under this article (“the current application”);

(b) it had refused a previous application under this article made by the same person, whether relating to the same part of the Register as the current application or to another part or parts of the Register; and

(c) since the time when the previous application was refused, the person has not been entered in the part of the Register to which the current application and the previous application relate, or (if they relate to different parts) has not been entered in any of those parts of the Register,

the Fitness to Practise Committee may direct that the person may make no further application under this article in respect of the part or parts of the Register to which the current application and the previous application (or each of two or more previous applications falling within sub-paragraphs (b) and (c)) relate.

(10) If the Fitness to Practise Committee gives a direction under paragraph (6) or (9), the Registrar must on its behalf send to the applicant at the applicant’s last known home address a statement in writing giving the applicant notice of the decision and the reasons for it and, in the case of a direction under paragraph (9), of the right of appeal under article 58.

Appeals against appealable fitness to practise decisions

58

(1) The following decisions are appealable fitness to practise decisions for the purposes of this Part—

(a) a decision of the Fitness to Practise Committee under article 54 to give a direction to remove the entry of a person from one or more parts of the Register;

(b) a decision of the Fitness to Practise Committee under article 54 to give a direction for suspension or for conditional entry (including a direction extending a period of earlier suspension or of conditional entry or making a period of suspension indefinite);

(c) a decision of the Fitness to Practise Committee under article 54 to give a direction to vary the conditions imposed by a direction for conditional entry; and

(d) a decision of the Fitness to Practise Committee to give a direction under article 57(9) that a person may make no further applications under that article in respect of one or more parts of the Register.

(2) A person in respect of whom an appealable fitness to practise decision has been made may appeal against that decision to the relevant court.

(3) Notice of any appeal under this article must be filed at, or in Scotland lodged in, the relevant court and served on the Council, in accordance with rules of court, within 28 days beginning with the date on which the written notice of the reasons for the decision was sent, or within such longer period as the relevant court may, in accordance with rules of court, allow.

(4) In this article, “the relevant court” means—

(a) in a case where the person making the appeal is domiciled in Scotland, the Court of Session; and

(b) in any other case, the High Court.

(5) Having considered the appeal, the relevant court may—

(a) dismiss the appeal;

(b) allow the appeal and quash the direction in respect of which the appeal is made;

(c) substitute for the direction in respect of which the appeal is made any other direction that the Fitness to Practise Committee could have given; or

(d) remit or refer the case to the Registrar or the Fitness to Practise Committee for disposal of the matter in accordance with the relevant court’s directions,

and may make such order as to costs or, in Scotland, expenses as the relevant court thinks fit.

The taking effect of directions in respect of appealable fitness to practise decisions

59

(1) Where an appealable fitness to practise decision is taken in respect of a direction, that direction does not take effect—

(a) until the period for bringing an appeal in respect of the direction has expired; or

(b) where an appeal is brought within the period for bringing an appeal, until the date on which the appeal is finally disposed of, is abandoned or fails by reason of its non-prosecution.

(2) Where, by virtue of paragraph (3) of article 58, the time for bringing an appeal in respect of the direction has been extended by the relevant court in accordance with rules of court—

(a) paragraph (1) applies to the direction as if the references to the period for bringing an appeal were references to that period as so extended; and

(b) if the relevant court allows an appeal to be brought after the expiration of the period for bringing an appeal specified in paragraph (3) of article 58, the direction is deemed not to have taken effect on the expiration of that period.

(3) Where, within the period for bringing an appeal (which includes that period as extended by virtue of article 58(3)), an appeal is brought against an appealable fitness to practise decision in respect of a direction (“the later direction”) that extends, varies or replaces an earlier direction, the earlier direction continues to have effect until the date on which the appeal is finally disposed of, is abandoned or fails by reason of its non-prosecution.

(4) Where, as a result of an extension of an earlier direction pursuant to paragraph (3), a later direction takes effect on a date after it was due to take effect, the period for which the later direction was originally expressed to have effect (howsoever expressed) is treated as commencing—

(a) on the date on which it was originally due to take effect; or

(b) if this would mean that the later direction would in practice expire before it commences, on the date on which the appeal is finally disposed of, is abandoned or fails by reason of its non-prosecution.

(5) For the purposes of paragraphs (3) and (4), an appeal is finally disposed of once all rights in relation to the appeal have been exhausted.

Interim measures pending a direction taking effect

60

(1) Paragraph (2) applies where, under article 54, the Fitness to Practise Committee gives—

(a) a direction to remove a registrant’s entry from one or more parts of the Register; or

(b) a direction for suspension.

(2) If the Fitness to Practise Committee is satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest or in the interests of the registrant, it may order that the entry of the registrant who is the subject of the direction in the part or parts of the Register to which the direction relates be suspended forthwith, pending the coming into force of the direction.

(3) Paragraph (4) applies where the Fitness to Practise Committee gives a direction for conditional entry under article 54.

(4) If the Fitness to Practise Committee is satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest or in the interests of the registrant, it may order that the entry of the registrant who is the subject of the direction in the part or parts of the Register to which the direction relates, be conditional upon that registrant complying, pending the coming into force of the direction, with such requirements specified in the order as the Committee thinks fit to impose.

(5) If the direction referred to in paragraph (1) or (3) relates to the entry of the registrant in more than one part of the Register, the Fitness to Practise Committee may make an order under paragraph (2) or, as the case may be, (4) in relation to only one part of the Register and may impose different requirements under paragraph (4) in relation to the registrant’s entry in different parts of the Register.

(6) Where the Fitness to Practise Committee makes an order under paragraph (2) or (4), the Registrar must send to the registrant who is the subject of the order at that registrant’s last known home address a statement in writing giving that registrant notice of the contents of the order and of the right of appeal under paragraph (7).

(7) A registrant who is aggrieved by a decision of the Fitness to Practise Committee to make an order under this article may appeal against that decision to the relevant court, and the court may—

(a) dismiss the appeal;

(b) in the case of an order under paragraph (2), terminate the suspension; and

and the decision of the relevant court on any application under this paragraph is final.

(8) In this article, “the relevant court” means—

(a) in a case where the person making the appeal is domiciled in Scotland, the Court of Session; and

(b) in any other case, the High Court.

PART 7 — Proceedings

Rules in respect of proceedings

61

(1) Subject to the following provisions of this Part, the Council must make such provision as it considers appropriate in rules in connection with the procedure to be followed and rules of evidence to be observed by—

(a) the Investigating Committee;

(b) the Fitness to Practise Committee (whether exercising functions under this Order or the Medicines Act 1968⁴²); and

(2) The rules under paragraph (1) in respect of the Fitness to Practise Committee or the Appeals Committee must, and in respect of the Investigating Committee may, include provision—

(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 1990⁴³ (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 1980⁴⁴ (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 1968⁴⁵ (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 1981⁴⁶ (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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 1946⁴⁷ (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 2006⁴⁸ (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 2006⁴⁹ (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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Registration in respect of provision of occasional pharmacy services

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Entitlement to provide occasional pharmacy services: first year

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

First provision of services: required documents

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

First provision of services: supplementary

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Duration of entitlement to provide occasional pharmacy services

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Conditions

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — Pharmacy technicians

Application and interpretation

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Registration in respect of the provision of occasional services

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Entitlement to provide occasional pharmacy services: first year

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

First provision of services: required documents

12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

First provision of services: supplementary

13

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

14

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Duration of entitlement to provide occasional pharmacy services

15

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Conditions

16

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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