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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(f) issuing further notices of a registrant’s entry in the Register pursuant to article 26(3).

(2) The Council must publish any such rules in such manner as it sees fit.

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

(4) Rules under paragraph (1) may provide for a fee not to be charged, or to be waived in whole or in part, in prescribed cases or circumstances (which may include cases or circumstances defined by reference to the discretion of the Registrar).

(5) Rules under paragraph (1) may also, in relation to the entry of registered pharmacies in the Register, provide for—

(a) fees to be charged by reference to different periods; and

(b) fees to be charged by reference to the location of a registered pharmacy.

(6) Before making rules under paragraph (1), the Council must consult such persons as it considers appropriate including, where it considers appropriate, persons appearing to it to represent—

(a) registrants;

(b) professional bodies or organisations recognised by the Council as representing registrants;

(d) persons or bodies commissioning or funding the services provided by registrants or at registered pharmacies.

Restoration to the Register of persons or premises removed from the Register

37

(1) Where the entry of a person in the Register has been removed from the Register—

(a) under article 25(3) pursuant to a decision by the Registrar under article 23(2)(b) to refuse to renew that entry;

(b) pursuant to article 28(2) or (3);

(d) pursuant to article 30(1) or (3);

(e) pursuant to rules made under article 31;

(f) pursuant to article 32(9)(a); or

(g) by reason of a failure by that person to comply with the requirements or conditions of the framework adopted by the Council under article 43(4)(a) or by reason of a false declaration made by that person about compliance with those requirements or conditions,

the Registrar may, upon an application being made to the Registrar by that person, restore that person to the Register in such circumstances as may be prescribed.

(2) Where the entry of a registered pharmacy has been removed from the Register—

(a) under article 14(4)(a) because the person who was carrying on a retail pharmacy business at the registered pharmacy failed to comply with the provisions of an improvement notice; or

(b) under rules made under section 74G of the Medicines Act 1968[^f00039] (voluntary removal from the register: Great Britain),

the Registrar may, upon an application being made to the Registrar by the person who, immediately prior to the removal, was carrying on the retail pharmacy business at the registered pharmacy, restore that pharmacy to the Register in such circumstances as may be prescribed.

(3) The Council may make such provision in rules as it considers appropriate in connection with applications for restoration pursuant to paragraphs (1) and (2) and may, in particular, make provision with regard to—

(a) the form and manner in which applications are to be made (including rules to the effect 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; and

(i) fitness to practise matters;

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

(iii) whether, and if so what, continuing professional development is required after restoration, and the rules may make provision—

(aa) for these issues to be determined in individual cases by the Registrar, and

(bb) enabling the Registrar to determine that the application for restoration is to be granted subject to the applicant agreeing to comply with such undertakings with regard to continuing professional development as the Registrar considers appropriate; and

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

(4) Where a person who has agreed to comply with an undertaking pursuant to rules made under paragraph (3)(c)(iii)(bb) breaches that undertaking, that breach may be treated as misconduct for the purposes of article 51(1)(a) and the Registrar must consider, in accordance with article 52(1), whether or not to refer the matter to the Investigating Committee or (where rules under article 52(1) so provide) the Fitness to Practise Committee.

(5) Where the Registrar refuses an application for restoration to Part 1 or 2 of the Register, 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 the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(6) Where the Registrar refuses an application for restoration to Part 3 of the Register, the Registrar must send to the person who, immediately prior to the removal of the entry of the registered pharmacy, was carrying on a retail pharmacy business at the registered pharmacy a statement in writing giving that person notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

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

(a) where the person who was carrying on the business is an individual, to that individual at that individual’s home address in the Register;

(b) where the person who was carrying on the business is a partnership, to that partnership at its principal office; or

(c) where the person who was carrying on the business is a body corporate, to that body corporate at its registered or principal office.

Offences relating to the Register

38

(1) A person who makes a false representation as to being—

(a) entered in the Register as a pharmacist;

(b) entered in the Register as a pharmacy technician; or

commits an offence.

(2) A person who—

(a) uses the title “pharmacist” or “fferyllydd” (its equivalent in the Welsh language) without being entered as a pharmacist in Part 1 ... of the Register;

(b) uses the title “pharmacy technician” or “technegydd fferylliaeth” (its equivalent in the Welsh language) without being entered as a pharmacy technician in Part 2 ... of the Register; or

(c) uses a title in respect of a particular annotation, which is a prescribed specialist title, where that person does not have an entry in any part of the Register with that particular annotation,

commits an offence.

(3) For the purposes of paragraph (2)(c), “prescribed specialist title” means—

(a) in the case of a pharmacist, a title for a pharmacist which the Council prescribes by rules as being a title that is only to be used by a registrant with a particular annotation; and

(b) in the case of a pharmacy technician, a title for a pharmacy technician which the Council prescribes by rules as being a title that is only to be used by a registrant with a particular annotation.

(4) A person who practises—

(a) as a pharmacist while not being entered as such in Part 1 ... of the Register; or

(b) as a pharmacy technician while not being entered as such in Part 2 ... of the Register,

commits an offence.

(5) A person who exhibits any notice or certificate which—

(a) purports to be a notice of entry issued under article 26 in respect of a pharmacist but which is not a notice of entry issued under that article in respect of a pharmacist;

(b) purports to be a certificate of registration issued under one of the Pharmacy Acts in respect of a pharmaceutical chemist but which is not a certificate of registration issued under one of those Acts in respect of a pharmaceutical chemist; or

(c) purports to be a certificate of registration issued under the 2007 Order in respect of a pharmacist but which is not a certificate of registration issued under that Order in respect of a pharmacist,

commits an offence.

(6) A person who exhibits any notice or certificate which—

(a) purports to be a notice of entry issued under article 26 in respect of a pharmacy technician but which is not a notice of entry issued under that article in respect of a pharmacy technician;

(b) purports to be a certificate of registration issued under the 2007 Order in respect of a pharmacy technician but which is not a certificate of registration issued under that Order in respect of a pharmacy technician,

commits an offence.

(7) A person who, for fraudulent purposes—

(a) uses or lends to, or allows to be used by, another person—

(i) a notice of entry or certificate of registration in respect of a pharmacist or a pharmaceutical chemist (whether issued under article 26 or one of the Pharmacy Acts or the 2007 Order), or

(ii) a notice of entry or certificate of registration in respect of a pharmacy technician issued under article 26 or the 2007 Order; or

(b) makes or possesses any document closely resembling such a notice or certificate,

commits an offence.

(8) Any person who commits an offence under paragraph (1), (2) or (4) is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(9) Any person who commits an offence under paragraph (5), (6) or (7) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(10) Proceedings for an offence under this article may be begun—

(a) in England and Wales, at any time within the period of 6 months beginning with the date on which evidence sufficient in the opinion of the Council to justify a prosecution came to the Council’s knowledge;

(b) in Scotland, at any time within the period of 6 months beginning with the date on which evidence sufficient in the opinion of the prosecutor to justify a prosecution came to the prosecutor’s knowledge,

but no proceedings may be begun after the expiry of the period of two years beginning with the date of the commission of the offence.

Appealable decisions

39

(1) Subject to paragraph (2), the following decisions are appealable decisions for the purposes of article 40—

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

(b) a decision by the Registrar to refuse to enter a person in Part 1 or 2 of the Register as a pharmacist or a pharmacy technician (excluding restoration cases);

(ca) a decision by the Registrar to require a person to undergo an examination or other assessment under article 23A(6)(a);

(cb) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) a decision by the Registrar under article 23(2)(b) to refuse to renew an entry of a registrant in Part 1 or 2 of the Register;

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f) a decision by the Registrar to refuse to enter, renew or restore an annotation in any part of the Register in respect of a specialisation pursuant to rules under article 27(1);

(g) a decision by the Registrar to remove an annotation in respect of a specialisation from any part of the Register pursuant to rules under article 27(1);

(h) a decision by the Registrar to remove the entry of a registrant from Part 1 or 2 of the Register pursuant to article 28(2) or (3);

(i) a decision by the Registrar to remove the entry of a registrant from Part 1 or 2 of the Register or a registered pharmacy from Part 3 of the Register pursuant to article 29(3)(a) or (b);

(j) a decision by the Registrar to remove the entry of a registrant from Part 1 or 2 of the Register pursuant to article 30(1) or (3);

(k) a decision by the Registrar to remove an entry of a registrant from Part 1 or 2 of the Register under article 32(9)(a);

(l) a decision by the Registrar to refuse an application for restoration of a person’s entry in Part 1 or 2 of the Register but only if the decision is for a reason that does not relate to a person’s fitness to practise;

(m) a decision by the Registrar in accordance with rules made by the Council under article 43(7) to suspend the entry of a registrant in the Register or to remove such an entry from the Register on the ground that the registrant has failed to comply with the requirements or conditions of the framework adopted by the Council under article 43(4)(a) or has made a false declaration about compliance with those requirements or conditions;

(n) a decision by the Council under article 47(6)(a) or (b) to refuse to approve, or to withdraw approval from, any education, training, qualification, test or institution or other provider or to impose probationary or remedial measures on an institution or other provider;

(o) a decision by the Registrar to refuse to enter a person in Part 2 of the Register under paragraph 6(2) of Schedule 5 on the ground that the person does not have the requisite knowledge, skill and experience for practising as a pharmacy technician in Great Britain;

(p) a decision by the Registrar under section 74A of the Medicines Act 1968[^f00040] (registration of premises: Great Britain) to refuse to enter premises in Part 3 of the Register or to refuse to renew the entry of premises in Part 3 of the Register;

(q) a decision by the Registrar under section 74H of the Medicines Act 1968[^f00041] (change of ownership of retail pharmacy business: Great Britain) not to restore an entry of premises to Part 3 of the Register;

(r) a decision by the Registrar under paragraph (4) of article 14 to suspend or remove an entry of premises in Part 3 of the Register; ...

(s) a decision which, by virtue of rules under this Order, may be appealed to the Appeals Committee;

(t) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(u) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(1A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) A decision is not an appealable decision if it was taken—

(a) because of a failure to pay any fee prescribed under article 36(1); or

(b) because the applicant is not appropriately qualified, in circumstances where the applicant contends that the applicant’s qualifications should be approved by the Council pursuant to article 21(1)(d)(i) or 22(1)(c)(i) .

(3) The reference in paragraph (1)(l) to a person’s fitness to practise does not include a reference to a person’s fitness to practise where the only allegation made in relation to the person is an allegation under article 51(1)(ca).

Appeals to the Appeals Committee

40

(1) Except as provided for by paragraphs (2) and (3), a person in respect of whom an appealable decision has been made may appeal against it to the Appeals Committee by giving notice of appeal to the Registrar within 28 days beginning with the date on which the written statement of the reasons for the decision was sent.

(1A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In the case of an appealable decision to which paragraph (4) or (9) of article 24 applies, the person in respect of whom that decision has been made may appeal against it to the Appeals Committee by giving notice of appeal to the Registrar within 28 days beginning with the date on which by virtue of that paragraph—

(a) the application is taken to have been refused by the Registrar; ...

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

(3) In the case of an appealable decision to which paragraph (6)(a) or (b) of article 47 applies, the institution or other provider on which probational or remedial measures have been imposed or from or in relation to which approval has been withdrawn or refused may bring an appeal to the Appeals Committee by giving notice of appeal to the Council within 28 days beginning with the date on which the decision is made or within such longer period as the Council may, in the circumstances of any particular case, allow.

(4) Where, on an application by a person in respect of whom an appealable decision to which paragraph (1) relates has been made, the Registrar is satisfied that that person did not receive the written statement of the reasons for the decision within 14 days of the statement being sent, the Registrar may by authorisation in writing extend the time for giving notice of appeal under paragraph (1).

(5) Where an appealable decision to which paragraph (3) relates has been taken, the decision to impose probational or remedial measures on, or to refuse approval of or withdraw approval from, an institution or other provider does not take effect—

(a) until the period for bringing an appeal in respect of the decision has expired, but if the period for bringing an appeal has been extended under paragraph (4), that extended period is, for the purposes of this paragraph, to be treated as a period for bringing an appeal (notwithstanding that this may require reversal of the action taken); and

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

(6) Where an appealable decision has been taken to remove an entry or an annotation in respect of a person or a registered pharmacy from any part of the Register, or to refuse to renew such an entry or annotation in any part of the Register, the decision does not take effect—

(a) until the period for bringing an appeal in respect of the decision has expired, but if the period for bringing an appeal has been extended under paragraph (4), that extended period is, for the purposes of this paragraph, to be treated as the period for bringing an appeal (notwithstanding that this may require reversal of the action taken); and

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

(7) Having considered the appeal, the Appeals Committee may—

(a) dismiss the appeal;

(b) allow the appeal and quash the decision appealed against ... ;

(c) substitute for the decision appealed against any other decision that the person taking the decision could have taken; ...

(ca) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . or

(d) remit or refer the case to the Registrar for disposal of the matter in accordance with the Appeals Committee’s directions.

(8) The Appeals Committee must, as soon as reasonably practicable, send to the person bringing the appeal a statement in writing giving the person notice of the Committee’s decision and the reasons for it and of any right of appeal under article 41(1).

(9) Except as provided in paragraph (10), the statement referred to in paragraph (8) must be sent—

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

(b) where the appellant is a partnership, to that partnership at its principal office; and

(10) Where the appellant is an institution or other provider on which probational or remedial measures have been imposed or from or in relation to which approval has been withdrawn or refused, the statement referred to in paragraph (8) must be sent to that institution or other provider at the last known address of that institution or other provider.

(11) Subject to paragraph (12), the Appeals Committee must, as soon as reasonably practicable, publish, in such manner as it sees fit, its decision and the reasons for it.

(12) If the Appeals Committee has allowed the appeal, or has taken a decision or issued a direction that has the effect of allowing the appeal, it is not required to publish its decision and the reasons for it unless the person making the appeal so requests.

(13) For the purposes of paragraphs (5) and (6) an appeal is finally disposed of once all rights in relation to the appeal have been exhausted.

(14) In this article any reference to a person in respect of whom an appealable decision has been made is, in a case where the decision relates to a registered pharmacy, or to premises that have been or would have been a registered pharmacy, to be construed as a reference to the applicant for registration or, as the case may be, to the person who is or has been carrying on a retail pharmacy business at the premises.

Appeals from the Appeals Committee

41

(1) Except where the Appeals Committee has allowed an appeal, or has taken a decision or issued a direction that has the effect of allowing the appeal, a person in respect of whom a decision by the Appeals Committee has been taken may appeal against that decision to the relevant court.

(2) 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 the rules of court, allow.

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

(a) in the case of an appeal relating to an individual domiciled in Scotland or to premises in Scotland, the sheriff in whose sheriffdom the individual is domiciled or the premises are located; and

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

(4) Having considered an appeal under this article, the relevant court may—

(a) dismiss the appeal;

(b) allow the appeal and quash the decision appealed against ...;

(ca) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . or

(d) remit or refer the case to the Registrar 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.

PART 5 — Education, training and acquisition of experience and continuing professional development

Education, training and acquisition of experience

42

(1) In connection with its general function under article 4(3)(e), in so far as that function relates to the education, training and acquisition of experience of registrants and prospective registrants, the Council must—

(a) ... ... , set the standards of proficiency for the safe and effective practice of pharmacy which it is necessary for a person to achieve in order to be entered in Part 1 or 2 of the Register as a pharmacist or, as the case may be, a pharmacy technician; and

(b) set—

(i) the standards of education, training and experience that providers of education and training must meet in order to enable a person undertaking such education or training, or acquiring such experience, to achieve the standards referred to in sub-paragraph (a) having regard, in particular, to the outcomes to be achieved, and

(ii) any requirements to be satisfied for admission to, and continued participation in, education and training for prospective pharmacists or prospective pharmacy technicians, which may include requirements as to fitness to practise unimpaired by health.

(2) The Council must publish the standards and requirements set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) The Council must—

(a) ensure that all providers in Great Britain concerned with the education and training of prospective pharmacists and prospective pharmacy technicians are notified of the standards and requirements set under paragraph (1)(b)(i) and (ii); and

(b) take appropriate steps to satisfy itself that those standards and requirements are met.

(4) The Council may—

(a) approve, or arrange with others to approve, courses of education or training which the Council is satisfied confer, or would confer, on persons completing them successfully the standards of proficiency referred to in paragraph (1)(a);

(b) approve, or arrange with others to approve, such other courses of education or training as the Council considers appropriate;

(c) approve, or arrange with others to approve, qualifications which are granted following success in an examination, or some other assessment, taken as part of an approved course;

(d) approve, or arrange with others to approve, such tests of competence, or tests of proficiency in the knowledge and use of English, as the Council may require; or

(e) approve, or arrange with others to approve—

(i) institutions,

(ii) other providers, including tutors,

of postgraduate education and training which leads to an approved qualification, if the Council considers that they are properly organised and equipped for conducting the whole or part of an approved course;

(f) approve, or arrange with others to approve, premises as being suitable for postgraduate education and training which leads to an approved qualification.

(5) In connection with paragraph (4), the Council may approve, or arrange with others to approve—

(a) a course of education or training run outside Great Britain which is intended to lead to an approved qualification;

(b) an institution or other provider of a course of education or training to which sub-paragraph (a) refers.

(6) The Council must publish a statement of—

(a) the criteria by reference to which the standards of education, training and experience referred to in paragraph (1)(b)(i) are set; and

(b) the criteria that will be taken into account in deciding whether to grant approval under paragraph (4),

as they exist from time to time.

(7) The Council must publish and maintain a list of the courses of education and training, qualifications and institutions or other providers (including tutors)—

(a) which are for the time being approved under this Order; or

(b) which have been approved under this Order but which are no longer so approved,

together with a record of the periods in respect of which approval was given.

(8) References in this Part to an approved course of education and training, an approved qualification, an approved test or an approved institution or other provider are references to such a course, qualification, test, institution or other provider approved under paragraph (4).

Continuing professional development

43

(1) In connection with its general function under article 4(3)(e), in so far as that function relates to the continuing professional development of registrants, the Council must—

(a) set the standards of proficiency for the safe and effective practice of pharmacy which it is necessary for a registrant to maintain in order to have an entry in Part 1 or 2 of the Register renewed; and

(b) set the standards of continuing professional development which it is necessary for a registrant to maintain in order to continue to meet the standards of proficiency referred to in sub-paragraph (a).

(2) The Council must publish the standards set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) The Council must—

(a) consult such persons as it considers appropriate about the development of criteria by reference to which compliance with the standards set under paragraph (1)(b) is to be monitored; and

(b) publish those criteria as they exist from time to time in such manner as it considers appropriate.

(4) The Council must—

(a) adopt and maintain a framework relating to the requirements and conditions to be met by registrants in respect of their continuing professional development; and

(b) require registrants—

(i) to complete an annual declaration regarding their compliance with such requirements and conditions in respect of their continuing professional development as they are obliged to meet by that framework, and

(ii) to submit records about any continuing professional development undertaken by them to the Registrar for review.

(5) The framework adopted by the Council under paragraph (4)(a)—

(a) must include provision relating to—

(i) the amount and type of continuing professional development that a registrant is required to undertake,

(ii) the information to be provided by a registrant about the continuing professional development that the registrant has undertaken and the form and manner in which that information is to be provided,

(iii) the times at which information about the continuing professional development that a registrant has undertaken is to be provided (including any continuing professional development that relates to an annotation in respect of a particular specialisation that is to be recorded in the Register),

(iv) the keeping of records about the continuing professional development undertaken by registrants; and

(b) must require that any continuing professional development that is undertaken by a registrant in accordance with it is relevant to—

(i) the safe and effective practice of pharmacy, and

(ii) a learning need for the individual registrant that is relevant to the current scope of the practice of pharmacy including any specialisation of that individual registrant and the environment in which they practise;

(6) The Council must publish the framework adopted by it under paragraph (4)(a), as it exists from time to time, in such manner as it considers appropriate.

(7) The Council must make such provision in rules as it considers appropriate with respect to registrants who fail to comply with any requirements of the framework adopted by the Council under paragraph (4)(a).

(8) Rules under paragraph (7) must—

(a) make provision about the circumstances in which the Registrar may remove the entry of a registrant from the Register, or impose such other remedial measures as may be prescribed in the rules, where the registrant—

(i) has failed to comply with the requirements or conditions of the framework adopted by the Council under paragraph (4)(a) relating to the continuing professional development of registrants; or

(ii) has made a false declaration about compliance with those requirements or conditions;

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

(c) make provision for the Registrar to send a statement in writing to the registrant concerned at the registrant’s last known home address giving that registrant notice of the removal and the reasons for it and of right of appeal to the Appeals Committee under article 40; and

(d) make provision for the suspension of a registrant’s entry in the Register pending the outcome of any appeal against a decision to remove the registrant from the Register.

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

Specific obligations and powers of the Council in respect of education and training

44

(1) In the exercise of its function under article 4(3)(e), the Council must—

(a) determine—

(i) programmes or courses in respect of, or any combination of, education, training or experience required in order to obtain an annotation in respect of a specialisation,

(ii) the amount and type of education, training and experience required in order to obtain an annotation in respect of a specialisation,

(iii) the education, training and experience that is necessary to address fitness to practise matters;

(b) hold or cause to be held assessments in respect of—

(i) approved qualifications, or any education, training or experience leading to an approved qualification,

(ii) additional education, training or experience required for the purposes of article 20(1)(a)(iii), and

(iii) becoming and acting as tutors of, or in relation to, any education, training or experience leading to an approved qualification or any additional education, training or experience required for the purposes of article 20(1)(a)(iii),

and determine the arrangements under which those assessments are to be held (including arrangements for dealing with disciplinary matters with regard to candidates and prospective candidates);

(c) appoint or arrange for the appointment of persons (“examiners”) to carry out or oversee assessments of the type mentioned in paragraph (b), and pay them 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; and

(d) establish, publish and maintain lists of premises that are to be used as training establishments.

(2) The duty imposed by paragraph (1)(c) does not prevent the Council from determining arrangements under which assessments of the type mentioned in paragraph (1)(b) are to be held which do not involve examiners.

Visitors

45

(1) The Council may appoint persons (“visitors”) to visit any place at which, or any institution or other provider by which, or under whose direction—

(a) any relevant course of education or training is, or is proposed to be, given;

(b) any examination or other assessment is, or is proposed to be, held in connection with any such course; or

(c) any test of competence is, or is proposed to be, conducted in connection with any such course or for any other purposes connected with this Order.

(2) For the purposes of this article, “test of competence” includes such tests of proficiency in the knowledge and use of English as the Council may require.

(3) In this article, “relevant course of education or training” means—

(a) any course of education or training which forms, or is intended to form, part of an approved course of education or training; or

(b) any course which a registrant may be required to undergo for the purpose of applying for an annotation in respect of a specialisation to be made to an entry in a part of the Register in accordance with rules made by the Council under article 27.

(4) No visitor may exercise the functions of a visitor under this Order in relation to—

(a) any place at which that visitor regularly gives instruction in any subject; or

(b) any institution or other provider with which that visitor has, in the opinion of the Council, a significant connection.

(5) A person is not prevented from being a visitor merely because that person is a member of the Council or any of its committees; but no person may be a visitor if that person is employed by the Council.

(6) Visitors must be selected with due regard to the profession with which the education and training they are to report on is concerned and at least one of the visitors must be entered in a part of the Register which relates to that profession.

(7) Where a visitor visits any place or institution or other provider in the exercise of the functions of a visitor under this article, the visitor—

(a) must report to the Council—

(i) on the nature, content and quality of the instruction given, or to be given, and the facilities provided, or to be provided, at that place or by that institution or provider, and

(ii) on such other matters (if any) as the Council may require; and

(b) may, having regard to the contents of the report in so far as it relates to the matters referred to in sub-paragraph (a)(i), send a copy of the report to the inspectorate established under article 8(1).

(8) Requirements of the kind mentioned in paragraph (7)(a)(ii) may be imposed by the Council—

(a) generally in relation to all visits made to a specified kind of place or institution or other provider or in respect of a specified type of course; or

(b) specifically in relation to a particular visit.

(9) Where a visitor reports to the Council in accordance with paragraph (7)(a), the Council must on receipt of the report—

(a) send a copy of it to the institution or other provider concerned; and

(b) notify that institution or other provider of the period within which it may make observations on the report.

(10) The period specified by the Council in a notice given under paragraph (9)(b) must not be less than one month beginning with the date on which a copy of the report is sent to the institution or other provider concerned under paragraph (9)(a).

(11) The Council must not take any steps in the light of any report made under paragraph (7) before the end of the specified period mentioned in paragraph (10).

(12) The Council must publish such reports together with, at the request of the institution or other provider concerned, the response of that institution or provider to the report.

(13) The Council may make such provision in respect of visitors as it may reasonably determine—

(a) for the payment of allowances, including the payment of allowances to employers of visitors, for the purposes of enabling visitors to perform functions under this article; and

(b) for the reimbursement of such expenses as visitors may reasonably have incurred in the course of carrying out their functions under this article.

Information to be given by institutions or other providers

46

(1) This article applies to any institution or other provider in Great Britain by which, or under whose direction, whether inside or outside Great Britain—

(a) any relevant course of education or training is, or is proposed to be, given; or

(b) any test of competence is, or is proposed to be, conducted in connection with any such course or for any other purpose connected with this Order.

(2) In paragraph (1), “test of competence” and “relevant course of education or training” have the same meaning as in article 45.

(3) Whenever required to do so by the Council, any institution or other provider to which this article applies must give to the Council such information and assistance as the Council may reasonably require in connection with the exercise of its functions under this Order.

(4) Where an institution or other provider refuses any reasonable request for information made by the Council under this article, the Council may, in accordance with article 47, refuse to approve or withdraw approval from, any course of education or training, qualification, test or institution or other provider to which the information relates.

Refusal or withdrawal of approval of courses, qualifications and institutions

47

(1) Paragraph (2) applies to a case where, as a result of any visitor’s report or other information acquired by the Council, the Council is of the opinion that—

(a) the standards set under article 42(1)(b)(i) are not, or will not, be met by an institution or other provider; or

(b) an institution or other provider is not observing the requirements referred to in article 42(1)(b)(ii).

(2) In a case to which this paragraph applies, the Council may—

(a) impose such probationary or remedial arrangements (including action plans for providers of new courses) or such conditions as may be prescribed; or

(b) refuse to approve, or withdraw approval from, any course of education or training, qualification, test, or institution or other provider to which that opinion relates.

(3) If the Council is considering taking any action under paragraph (2)(a) or (b), the Council must act in accordance with paragraphs (4) to (6).

(4) The Council must—

(a) notify the institution or other provider concerned of its opinion, setting out its reasons; and

(b) inform the institution or other provider of the period within which it may make observations on the matters raised, which must not be less than one month beginning with the date on which the reasons are sent to the institution or other provider under sub-paragraph (a).

(5) The Council may take no further steps before the expiry of the period about which the institution or other provider has been informed under paragraph (4)(b).

(6) If, taking account of any visitor’s report or other information acquired by the Council together with any observations submitted by the institution or other provider under paragraph (4), the Council decides that it is appropriate to—

(a) impose probationary or remedial arrangements or conditions on the institution or other provider; or

(b) refuse or withdraw approval,

it must send to the institution or other provider concerned at the last known address of the institution or provider a statement in writing giving the institution or other provider notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(7) A decision under paragraph (6) has effect from the date of the decision or from such later date as may be specified in the decision.

(8) Where, under this article, approval of a course of education or training or an institution or other provider is withdrawn, the Council must use its best endeavours to secure that any person who, at that time, is undertaking that course or is studying at that institution or with that other provider is given the opportunity to attend an approved course conducted by an approved institution or other provider.

(9) Where, under this article, approval of a qualification, a course of education or training or an institution or other provider is withdrawn, that withdrawal does not affect the entitlement of any person to be entered in a part of the Register on the basis of the award of a qualification to that person before the date on which the decision withdrawing approval from that qualification, the course of education or training which led to the award of that qualification or, as the case may be, the institution or other provider that conducted the course that led to the award of that qualification, had effect.

PART 6 — Fitness to practise

Standards of conduct and performance

48

(1) The Council must—

(a) set standards relating to the conduct, ethics and performance expected of registrants; and

(b) make provision in rules regarding the criteria to which the Fitness to Practise Committee is to have regard when deciding, in the case of any registrant, whether or not the requirements as to fitness to practise are met in relation to that registrant.

(1A) The standards set under this article may include standards which relate only to the conduct, ethics and performance expected of registered pharmacists who are—

(za) chief pharmacists for the purposes of section 67F of the Medicines Act 1968,

(a) responsible pharmacists for the purposes of sections 70 to 72 of the Medicines Act 1968, or

(b) superintendent pharmacists.

(1B) Where the standards set under this article include standards of the type mentioned in paragraph (1A), the standards may include a description of the professional responsibilities of chief pharmacists, responsible pharmacists or (as the case may be) superintendent pharmacists.

(1C) The standards set under this article may include standards which relate to the conduct, ethics and performance expected of registered pharmacists giving authorisations for the purposes of regulation 220B(1)(b) of the Human Medicines Regulations 2012.

(1D) Where the standards set under this paragraph include standards of the type mentioned in paragraph (1C), the standards may include a description of the professional responsibilities that the registered pharmacists have—

(a) for the documentation of authorisations given orally, as mentioned in regulation 220B(1)(b)(i) of the Human Medicines Regulations 2012; and

(b) as a consequence of the professional accountability that the registered pharmacists retain for any selling or supplying that is done pursuant to the authorisation that they have given, and in particular for ensuring due regard for patient safety.

(2) The Council must publish the standards set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) Where any registrant is alleged to have failed to comply with standards set under this article, that failure—

(a) is not, of itself, to be taken to constitute misconduct on the registrant’s part; but

(b) is to be taken into account in any proceedings against the registrant under this Order.

Disclosure of information: general

49

(1) For the purpose of assisting the Council (including its staff and its committees) in carrying out functions in respect of the fitness to practise of a registrant, or of assisting the Registrar in carrying out functions in respect of identifying any person entered in the Register by virtue of article 34(1)(b), a person authorised by the Council may require—

(a) a registrant (except the registrant in respect of whom the information or document is sought); or

(b) any other person,

who, in the opinion of the authorised person, is able to supply information or produce any document which appears to be relevant to the discharge of any such function, to supply the information or produce the document.

(2) Nothing in paragraph (1) 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, the person authorised by the Council may require that information to be put in a form which does not allow for the identification of that individual; or

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

(3) In determining for the purposes of paragraph (2)(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 (1) of this article.

(4) If a person fails to supply any information or to produce any document within 14 days of being required to do so under paragraph (1), or within such longer period as the Council in the circumstances of a particular case may allow, the Council may seek an order of the relevant court requiring the information to be supplied or the document to be produced.

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

(a) in a case where the person in respect of whom the information or document is sought is domiciled in Scotland, the sheriff in whose sheriffdom that person is domiciled; and

(b) in any other case, the county court (the Central London County Court if the person in respect of whom the information or document is sought is not domiciled in Great Britain).

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

Disclosure of fitness to practise matters in the public interest

50

(1) The Council may, if it considers it to be in the public interest to do so, publish or disclose to any person—

(a) information which relates to a particular pharmacist’s or pharmacy technician’s fitness to practise, whether the matter to which the information relates arose before or after the entry in the Register of that pharmacist or pharmacy technician, or arose in Great Britain or elsewhere; or

(b) information of a particular description related to fitness to practise in relation to every pharmacist or pharmacy technician, or to every pharmacist or pharmacy technician of a particular description.

(2) For the purposes of paragraph (1)(b), the Council need not consider whether it is in the public interest to publish or disclose the information in question in relation to each individual pharmacist or pharmacy technician to whom it relates.

Impairment of fitness to practise

51

(1) A person’s fitness to practise is to be regarded as “impaired” for the purposes of this Order only by reason of—

(a) misconduct;

(b) deficient professional performance (which includes competence);

(c) adverse physical or mental health which impairs their ability to practise safely and effectively or which otherwise impairs their ability to carry out the duties of a pharmacist or a pharmacy technician in a safe and effective manner;

(ca) not having the necessary knowledge of English;

(d) failure to comply with a reasonable requirement imposed by an individual assessor or an assessment team in connection with carrying out a professional performance assessment;

(e) a conviction in the British Islands for a criminal offence;

(f) a conviction elsewhere than in the British Islands for an offence which, if committed in England, Wales or Scotland, would constitute a criminal offence;

(g) an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995[^f00043] discharging the person absolutely (admonition and absolute discharge);

(h) having accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995[^f00044] (fixed penalty: conditional offer by procurator fiscal);

(i) having agreed to pay a penalty under section 115A of the Social Security Administration Act 1992[^f00045] (penalty as alternative to prosecution);

(j) a police caution in the British Islands;

(k) having agreed to be bound over to keep the peace by a magistrates’ court in England or Wales;

(l) a determination made by a regulatory body in the United Kingdom responsible under any enactment for the regulation of a health or social care profession to the effect that the person’s fitness to practise as a member of a profession regulated by that body is impaired, or a determination by a regulatory body elsewhere to the same effect;

(m) the Disclosure and Barring Service including the person in a barred list (within the meaning of the Safeguarding Vulnerable Groups Act 2006[^f00046] or the Safeguarding Vulnerable Groups (Northern Ireland) Order 2007[^f00047]); or

(n) the Scottish Ministers including the person in the children’s list or the adults’ list (within the meaning of the Protection of Vulnerable Groups (Scotland) Act 2007[^f00048]).

(2) The demonstration towards a patient or customer, or a prospective patient or customer, by a pharmacist or pharmacy technician of attitudes or behaviour from which that person can reasonably expect to be protected may be treated as misconduct for the purposes of paragraph (1)(a).

(3) References in this article to a conviction include a conviction by court martial.

(4) A person’s fitness to practise may be regarded as impaired because of matters arising—

(a) outside Great Britain; and

(b) at any time.

(5) The Council may make such provision in rules as it considers appropriate in connection with the information to be provided to the Registrar by a registrant about fitness to practise matters that arise while the registrant is entered in any part of the Register.

(6) If a registrant fails to comply with rules under paragraph (5), the failure may be treated as misconduct for the purposes of paragraph (1)(a) and the Registrar must consider, in accordance with article 52(1), whether or not to refer the matter to the Investigating Committee or (where rules under article 52(1) so provide) the Fitness to Practise Committee.

Initial action in respect of allegations

52

(1) Where—

(a) an allegation is made to the Council against a registrant that the registrant’s fitness to practise is impaired; or

(b) the Council has information that calls into question a registrant’s fitness to practise, even though no allegation to that effect has been made to the Council,

the Registrar must, except in such cases and subject to such considerations as the Council may prescribe, refer the matter (referred to in this article as “the allegation”) to the Investigating Committee.

(2) Rules under paragraph (1) may provide for—

(a) an allegation not to be referred where it is of a type that the Council has stated in threshold criteria, which it has published and which it may amend from time to time, should not be referred; and

(b) an allegation to be referred, in prescribed cases, directly by the Registrar to the Fitness to Practise Committee.

(3) Where the Registrar—

(a) refers an allegation directly to the Fitness to Practise Committee under rules made by virtue of paragraph (2)(b); and

(b) is of the opinion that the Fitness to Practise Committee should consider making an interim order under article 56,

the Registrar must notify the Committee accordingly.

(4) Where the Registrar refers an allegation to the Fitness to Practise Committee under rules made by virtue of paragraph (2)(b), the Registrar must inform the registrant who is the subject of the allegation and the person, if any, who made the allegation of that decision.

(5) Once a decision has been taken to refer the allegation to the Investigating Committee or (where rules so provide) the Fitness to Practise Committee, the Registrar must, as soon as is reasonably practicable—

(a) require from the registrant who is the subject of the allegation details of any person—

(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;

(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 1976[^f00049]; 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 1968[^f00051]); 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—

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