PART 1 Preliminary

Citation and commencement

1.—(1) This Order may be cited as the Pharmacists and Pharmacy Technicians Order 2007.

(2) As regards commencement—

(a) this article, article 2 and article 68 shall come into force on the making of this Order;

(b) the provisions of this Order, other than article 68, which confer powers enabling—

(i) rules to be made by the Council, or

(ii) orders to be made by the Privy Council,

shall come into force on the making of this Order, but for the purpose only of the exercise of those powers; and

(c) otherwise, the provisions of this Order shall come into force on such days as the Secretary of State may specify.

(3) Different days may be specified under paragraph (2)(c) above for different purposes, and any day so specified shall be caused to be notified in the London, Edinburgh and Belfast Gazettes published not later than one week before that day.

Extent

2.—(1) Subject to paragraphs (2) and (3), this Order extends to Great Britain.

(2) The following provisions—

(a) Part 3;

(b) Parts 4 to 6 in so far as they relate to registered pharmacy technicians or applicants for restoration to the Register of Pharmacy Technicians; and

(c) Part 2 of Schedule 2,

extend only to England and Wales.

(3) The extent of any amendment, revocation or repeal of any enactment or instrument set out in Schedule 1 is the same as that of the enactment or instrument amended, revoked or repealed.

Interpretation

3.—(1) In this Order—

“the 1954 Act” means the Pharmacy Act 1954(2), as in force immediately before article 1 comes into force;

“annotation” means an annotation in one of the Society’s registers;

“Appointments Commission” means the Appointments Commission established under section 57 of the Health Act 2006(3) (the Appointments Commission);

“assessment team” means a team of persons that has the functions of an assessment team by virtue of rules under article 53;

“the Charter” means the Charter granted to the Society on 7th December 2004, as amended from time to time;

“the Council” means the Council of the Society;

“enactment” includes an enactment comprised in, or an instrument made under, an Act of the Scottish Parliament;

“European mutual recognition area” means the territory of the EEA States and Switzerland;

“exempt person” means—

“fitness to practise committee” means the Investigating Committee, the Disciplinary Committee or the Health Committee;

“individual assessor” means a person who has the functions of an individual professional performance assessor by virtue of rules under article 53;

“the Pharmacy Acts” means the Pharmacy Act 1852(4), the Pharmacy Act 1868(5), the Poisons and Pharmacy Act 1908(6), the Pharmacy and Poisons Act 1933(7) and the 1954 Act;

“the Pharmacy Qualifications Directive” means Council Directive 85/433/EEC concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy(8), as amended(9);

“prescribed” means prescribed by the Council in rules under this Order, and “prescribes” shall be construed accordingly;

“the register” means, unless the context otherwise requires, as respects any registrant—

“the register of pharmaceutical chemists for Northern Ireland” means the register of pharmaceutical chemists maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976(10);

“registered pharmacist” means a person who is registered in the Register of Pharmacists;

“registered pharmacy technician” means a person who is registered in the Register of Pharmacy Technicians;

“registrant” means a registered pharmacist or a registered pharmacy technician;

“Registrar” shall, except where used in the expression “Registrar General”, be construed in accordance with article 9(1) and (5);

“Registrar General” means—

“regulatory body” means a regulatory body which has the function of authorising persons to practise as a member of a health or social care profession;

“relevant European State” means an EEA State or Switzerland;

“the Second General System Directive” means Council Directive 92/51/EEC on a second general system for the recognition of professional education and training(13), as amended(14);

“the Second General System Regulations” means the European Communities (Recognition of Professional Qualifications) (Second General System) Regulations 2002(15);

“the Society” means the Royal Pharmaceutical Society of Great Britain;

“the Society’s registers” means the Register of Pharmacists and the Register of Pharmacy Technicians; and

“statutory committees” means the committees listed in article 7(1)(a) to (f).

(2) For the purposes of this Order, a person practises as a pharmacist or a pharmacy technician if, whilst acting in the capacity of or holding himself out as a pharmacist or a pharmacy technician, he undertakes any work or gives any advice in relation to the dispensing or use of medicines, the science of medicines, the practice of pharmacy or the provision of health care.

The Society’s general duties

4.—(1) The main objective of the Society (including its Council, its staff and its committees) in exercising such of the Society’s functions as affect the health and safety of members of the public is to protect, promote and maintain their health and safety.

(2) In exercising its functions, the Society (including its Council, its staff and its committees) shall—

(a) have proper regard to the interests of—

(i) persons using or needing the services of registered pharmacists in Great Britain,

(ii) persons using or needing the services of registered pharmacy technicians in England and Wales, and

(iii) all registrants and prospective registrants, and to any differing interests of registered pharmacists and registered pharmacy technicians or groups within those professions; and

(b) co-operate, in so far as is appropriate and reasonably practicable, with public authorities or other bodies or persons concerned with—

(i) the employment (whether or not under a contract of service) of registrants,

(ii) the education or training of registrants, prospective registrants or other health care professionals,

(iii) the regulation of, or the co-ordination of the regulation of, other health or social care professions, and

(iv) the regulation of, or carrying out activities in connection with the regulation of, health services.

(3) In carrying out its duty to co-operate under paragraph (2)(b), the Society shall have regard to any differing considerations in relation to practising as—

(a) a pharmacist which apply in England, Scotland or Wales; or

(b) a pharmacy technician which apply in England or Wales.

The Council

5.—(1) The Privy Council may by order vary the size and composition of the Council (in addition to its powers to do so under the Charter(16)), provided that—

(a) the number of members of the Council who are registered pharmacists constitutes a majority of the total number of members of the Council; and

(b) the total number of members of the Council does not exceed 35.

(2) In exercising its function of appointing persons to the Council(17), the Privy Council shall ensure that, at any time, at least one of the persons on the Council appointed by it lives or works wholly or mainly in each of England, Scotland and Wales.

(3) The Council shall make regulations under the Charter(18) in respect of the suspension or removal from office of its members, and those regulations shall in particular provide for—

(a) a member of the Council who is a registered pharmacist to be removed from office forthwith if he ceases to be registered in Part 1 of the Register of Pharmacists; and

(b) a member of the Council who is a registered pharmacy technician to be removed from office forthwith if he ceases to be registered in Part 1 of the Register of Pharmacy Technicians.

(4) The Council shall—

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

(b) publish in such manner as it sees fit entries recorded in the register of members’ interests.

The Council’s duties in respect of publications

6.—(1) The Council shall publish in such manner as it sees fit, at least once in each calendar year, by such date in each calendar year as the Privy Council shall determine—

(a) a statistical report in respect of, and which includes a description of, the procedures which the Society has 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

(b) a report, submitted to the Privy Council, on the Society’s exercise of its functions, and the Privy Council shall lay before each House of Parliament a copy of the report submitted by the Council under this sub-paragraph.

(2) The Council shall be responsible for ensuring that the Society—

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

(b) prepares annual accounts in respect of each calendar year, which shall be in such form and shall be prepared by such date as the Privy Council may determine.

(3) Those annual accounts shall be audited by auditors appointed by the Council, but no person may be appointed as an auditor under this paragraph unless he is eligible for appointment as a company auditor under section 25 of the Companies Act 1989(19) (eligibility for appointment).

(4) As soon as is reasonably practicable after those annual accounts have been prepared, the Council shall—

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

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

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

(5) The Society shall from time to time publish or provide in such a manner as it sees fit information about the regulation of pharmacists and pharmacy technicians.

(6) The Society may from time to time publish or provide in such manner as it sees fit guidance to registrants, employers and such other persons 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.

The statutory committees

7.—(1) The Society shall have the following committees (in addition to any other committees established under the Charter(20))—

(a) the Continuing Professional Development Committee;

(b) the Disciplinary Committee;

(c) the Education Committee;

(d) the Health Committee;

(e) the Investigating Committee; and

(f) the Registration Appeals Committee,

each having the functions assigned to them by or under this Order, any other enactment or the Charter.

(2) Subject to paragraph (6), as regards each of the statutory committees, the Council shall by rules 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 a fitness to practise committee or the Registration Appeals Committee who are registrants shall 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;

(c) the quorum at its meetings; and

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

(3) The provisions with regard to the size, composition and procedures of the Health and Disciplinary Committees may 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 he 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, he must nevertheless 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.

(4) Rules under this article may in addition include provision with regard to—

(a) the education and training of members of statutory committees, 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 statutory committees;

(c) requiring statutory committees to—

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

(ii) publish in such manner as they see fit entries recorded in their register of members’ interests; and

(d) what functions a statutory committee is to perform (including functions of the Society under this Order) and how it is to perform those functions.

(5) Rules under this article shall provide that—

(a) no person shall be a member of more than one fitness to practise committee;

(b) no person shall be both a member of the Council and of the Continuing Professional Development Committee, the Disciplinary Committee, the Health Committee or the Registration Appeals Committee;

(c) no person who is a member of a Disciplinary Committee or Health Committee that has made an interim order under article 54 in proceedings in any case shall sit as a member of the Committee in subsequent proceedings in that case, unless the subsequent proceedings relate solely to interim measures under article 54; and

(d) the appointment, suspension or removal of the members, chairs and deputy chairs of the statutory committees, apart from the chairs and deputy chairs of the Disciplinary and Health Committees, shall be by the Council, except that the rules may provide for the Council to enter into arrangements with another person, body or group (including a committee established under the Charter) for that person, body or group to carry out all or any of these functions on the Council’s behalf.

(6) The appointment, suspension or removal of the chairs and deputy chairs of the Disciplinary and Health Committees shall be by the Privy Council, but the first chair of the Disciplinary Committee shall be the person who, immediately before the coming into force of this article, is the chairman of the Statutory Committee of the Society.

(7) The Privy Council may enter into arrangements with the Appointments Commission (and the Appointments Commission may enter into arrangements with the Privy Council) providing for the Appointments Commission to assist the Privy Council in connection with the exercise of the Privy Council’s functions under paragraph (6).

(8) Rules under this article 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 Society.

(9) The powers of a statutory committee may be exercised even though there is a vacancy on it.

Remuneration and allowances of Council members, committee members and specialist advisers

8.  The Council may pay to—

(a) its members;

(b) members of the statutory committees (including co-opted members); and

(c) advisers advising the Council or one of the Society’s committees on issues falling within an adviser’s speciality which are under consideration by it, including legal advisers appointed under article 61 and clinical and other specialist advisers appointed under article 62,

such remuneration and allowances as the Council may reasonably determine.

Appointment etc. of the Registrar and any Deputy Registrar

9.—(1) The Council shall appoint a fit and proper person to be Registrar who shall perform the functions of the Registrar conferred on him by this Order, by rules under this Order, by any other enactment or by, or by virtue of, the Charter.

(2) The Council may also appoint a Deputy Registrar.

(3) The Council may pay, or make provision for the payment of, such remuneration, allowances, pension or gratuities as it determines to the Registrar or any Deputy Registrar.

(4) The Council may terminate the appointment of the Registrar or any Deputy Registrar.

(5) The Registrar may authorise a Deputy Registrar or any employee of the Society to act for him in any matter, and where he does so, a reference in this Order, in rules under this Order, in any other enactment or in the Charter or any instrument under the Charter to the Registrar, if it relates to that matter, shall include reference to the person so authorised.

PART 2 Registration of pharmacists

The Register of Pharmacists

10.—(1) The Registrar shall maintain in accordance with the provisions of and rules under this Order the register established in pursuance of the Pharmacy Act 1852(21) and maintained in accordance with section 2 of the 1954 Act (the registers and registration).

(2) The register maintained under paragraph (1)—

(a) formerly known as the Register of Pharmaceutical Chemists, shall be known as the Register of Pharmacists; and

(b) shall be divided into two parts, and—

(i) the first part shall be known as “Part 1 – Practising Pharmacists”, and

(ii) the second part shall be known as “Part 2 – Non-practising Pharmacists”.

Entitlement to registration in the Register of Pharmacists

11.—(1) Subject to the provisions of and rules under this Order, a person shall be entitled to be registered in the Register of Pharmacists if—

(a) he satisfies the Registrar that—

(i) he is appropriately qualified within the meaning given in article 12(1),

(ii) his fitness to practise is not impaired,

(iii) before registration, where necessary, he has met such requirements as to additional education, training or experience as are appropriate to his case, and

(iv) after registration, he meets such requirements as to continuing professional development as are appropriate to his case; and

(b) he has paid any fee prescribed under article 40(1)(a) or (b) that relates to his registration in that register.

(2) A person who is entitled to be registered in the Register of Pharmacists is to be registered in Part 1 of that register unless he has given to the Society, in the form determined by the Registrar (which may be varied from time to time), an undertaking not to practise in Great Britain, the Channel Islands or the Isle of Man, in which case he is to be registered in Part 2 of that register.

(3) The Registrar shall treat a person who—

(a) is an exempt person who has qualified as a pharmacist in a relevant European State other than the United Kingdom;

(b) applies to be registered in the Register of Pharmacists; and

(c) is registered in the register of pharmaceutical chemists for Northern Ireland,

as meeting the requirements of paragraph (1)(a)(i).

Preregistration requirements for pharmacists in respect of qualifications and additional education, training or experience

12.—(1) For the purposes of article 11(1)(a)(i), a person is “appropriately qualified” if—

(a) he has a qualification awarded in Great Britain which has been approved by the Society as attesting to a standard of proficiency which, in the Society’s opinion, indicates that he has reached an adequate level of understanding for practising as a pharmacist (and so is also a recognised pharmacy qualification within other relevant European States);

(b) he is an exempt person and he has a qualification which the Privy Council has by order designated as being an approved qualification for the purpose of registration in the Register of Pharmacists; or

(c) he has, elsewhere than in Great Britain, undergone training as a pharmacist, and—

(i) he holds a qualification which has been approved by the Society as attesting to a standard of proficiency which, in the Society’s opinion, indicates that the person has reached an adequate level of understanding for practising as a pharmacist, or

(ii) he holds a qualification which—

(aa) in the case of an exempt person who does not have a qualification referred to in sub-paragraph (b), taken together with his additional education, training or experience acquired elsewhere than in Great Britain (but at least in part within the European mutual recognition area) indicates, in the Society’s opinion, that he has reached an adequate level of understanding for practising as a pharmacist, or

(bb) whether or not he is an exempt person, taken together with the additional education, training or experience that the Society requires him to undertake pursuant to article 11(1)(a)(iii), indicates, in the Society’s opinion, that he has reached an adequate level of understanding for practising as a pharmacist.

(2) An order under paragraph (1)(b) may provide that a qualification is only to be considered an approved qualification in such circumstances, or subject to such conditions, as are specified in the order.

(3) For the purposes of an application for entry in the Register of Pharmacists, the Registrar shall not require any exempt person to whom paragraph (1)(b) or (c)(ii)(aa) applies to meet any requirements as to additional education, training or experience, unless—

(a) the application is for restoration to that register; and

(b) in so doing the Registrar is acting in a manner that is consistent with the requirements of the Treaties and the Pharmacy Qualifications Directive.

(4) In formulating its opinion under paragraph (1)(c)(ii) in relation to an exempt person, the Society shall take into account—

(a) if the person holds a qualification granted outside the European mutual recognition area which has been accepted by another relevant European State as qualifying him to practise as a pharmacist in that State, the acceptance of that qualification; and

(b) all of the person’s relevant qualifications, knowledge and experience, wherever acquired.

(5) As regards any person to whom paragraph (1)(a) or (c)(i) or (ii)(bb) applies, for the purposes of meeting the requirements of article 11(1)(a)(iii), the Registrar may require him to meet requirements as to additional education which comprise or include reaching an adequate standard of proficiency in the knowledge and use of English, unless he is an exempt person.

General functions of the Society in respect of pharmacists’ and prospective pharmacists’ education, training and the acquisition of experience

13.  The Society shall have the general functions of—

(a) promoting high standards of education and training, and in respect of the acquisition of experience, for pharmacists and prospective pharmacists; and

(b) overseeing all stages of the education, training and acquisition of experience of pharmacists and prospective pharmacists in Great Britain, including—

(i) preregistration education, training and acquisition of experience, including both undergraduate and postgraduate education and training of prospective pharmacists,

(ii) post-registration education, training and acquisition of experience required for continuing professional development or required for education, training and acquisition of experience in respect of specialisations, and

(iii) education, training and acquisition of experience for persons seeking restoration to the Register of Pharmacists.

Specific obligations of the Society in respect of pharmacists’ and prospective pharmacists’ education, training and the acquisition of experience

14.  In connection with discharging the functions mentioned in article 13, the Society shall—

(a) determine—

(i) the nature of the knowledge and skills, and

(ii) the nature, extent and content of, and method of assessment for, the education, training and experience,

required for a person qualifying in Great Britain to be considered appropriately qualified for the purposes of article 11(1)(a)(i);

(b) approve qualifications under article 12(1)(a);

(c) accredit degree courses for prospective pharmacists (including degree courses in Northern Ireland) and approve providers of such courses;

(d) approve providers, including tutors, of postgraduate education and training for prospective pharmacists which leads to an approved qualification, and approval under this paragraph may be limited to the provision of education and training at specified premises;

(e) determine, as regards the tutors mentioned in paragraph (d)—

(i) the nature of the education, training or experience required of them,

(ii) any assessment arrangements in respect of them, and

(iii) their role and function;

(f) determine the arrangements for determining, in accordance with article 12(1)(c)(ii), that a person has reached an adequate level of understanding for practising as a pharmacist;

(g) determine assessment arrangements for—

(i) postgraduate education and training for prospective pharmacists which leads to an approved qualification, or

(ii) any additional education, training or experience required for the purposes of article 11(1)(a)(iii); and

(h) determine the nature, extent and content of the education, training, experience and continuing professional development required for the purposes of article 11(1)(a)(iii) and (iv), or for the purposes of obtaining annotations in respect of specialisations, including—

(i) preregistration programmes or courses in respect of, or any combination of, education, training or acquiring experience,

(ii) the amount and type of continuing professional development that registrants are required to undertake,

(iii) they amount and type of education, training and experience required in order to obtain annotations in respect of specialisations,

(iv) education and training to address fitness to practise matters, and

(v) education, training and acquisition of experience in respect of persons seeking restoration to the Register of Pharmacists or to move from Part 2 to Part 1 of that register.

Specific powers of the Society in respect of pharmacists’ and prospective pharmacists’ education, training and the acquisition of experience

15.  In connection with discharging the functions mentioned in article 13, the Society may—

(a) approve premises as being suitable for postgraduate education and training of prospective pharmacists;

(b) approve qualifications for the purposes of article 12(1)(c)(i);

(c) approve providers of particular types of education, training, experience or continuing professional development required for the purposes of article 11(1)(a)(iii) or (iv), or in respect of specialisations, and approval under this paragraph may be limited to activities at specified premises;

(d) approve programmes or courses in respect of particular types of education, training or continuing professional development required for the purposes of article 11(1)(a)(iii) or (iv), or in respect of specialisations;

(e) determine the arrangements (including, where appropriate, the minimum qualifications of candidates) under which a person may participate in assessment programmes or courses for prospective pharmacists;

(f) 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 11(1)(a)(iii), and

(iii) becoming and acting as the tutors referred to in article 14(d),

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);

(g) appoint or arrange for the appointment of persons (“examiners”) to carry out or oversee assessments of the types mentioned in article 14(g), or paragraph (f) of this article, and pay them or arrange for payment to them of appropriate remuneration and allowances (equally, the Society may determine arrangements under which assessments are to be held which do not involve examiners);

(h) charge fees in respect of—

(i) commencing preregistration education or training, other than undergraduate education or training, which is co-ordinated by the Society, and

(ii) assessments of the types mentioned in paragraph (f) that the Society holds or causes to be held; and

(i) determine—

(i) subject to any exceptional arrangements under sub-paragraph (iii), the maximum number of times that a candidate may attempt any assessment arrangements in respect of any education, training or experience leading to an approved qualification,

(ii) subject to any exceptional arrangements under sub-paragraph (iii), the shortest and longest periods for successful completion of approved qualifications or particular types of additional education, training or experience (including accredited courses or programmes), and

(iii) in individual cases, exceptional arrangements for the successful completion of approved qualifications or particular types of additional education, training or experience by a candidate or prospective candidate for whom the Society considers it appropriate to make adjustments to the standard arrangements.

Supplemental matters in connection with articles 14 and 15

16.—(1) The Society may enter into arrangements with another body for that body to assist the Society in carrying out its functions under articles 14 and 15.

(2) Approval or accreditation may be granted under articles 14 and 15 in respect of a programme or course of education or training that only provides part of the education or training needed for an approved or accredited course or programme, or for an approved qualification, where the Society is satisfied that there are appropriate arrangements in place for persons participating in the education or training to receive the remainder of the education or training necessary for the approved or accredited course or programme, or for the approved qualification, elsewhere.

(3) The Council may make such provision in rules in connection with—

(a) authorising the Registrar to perform any of the Society’s functions under articles 14 and 15;

(b) the making, varying, suspending or revoking of any determination under articles14 and 15;

(c) as regards approvals or accreditations under articles 14 and 15—

(i) granting (including provisionally granting) or refusing any approval or accreditation,

(ii) probationary arrangements (including action plans for providers of new courses) or the imposition of remedial measures, and

(iii) appeals related to paragraphs (i) and (ii); and

(d) appeals by candidates and prospective candidates in relation to the assessment arrangements determined under articles 14 and 15,

as it considers appropriate.

(4) The Council shall provide in rules for the procedure to be followed (including, where appropriate, the appeals procedure) for withdrawing or suspending any approval or accreditation that the Society has granted under articles 14 and 15.

(5) In making, varying, suspending or revoking any determination mentioned in this article, or granting, refusing, suspending or withdrawing any accreditation or approval mentioned in this article, the Society shall ensure that the relevant requirements of—

(a) the Treaties;

(b) the Pharmacy Qualifications Directive; and

(c) the Council Directive 85/432/EEC concerning the co-ordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy(22), as amended(23),

are met, and shall act in a manner which is consistent with those requirements.

(6) Determinations, approvals and accreditations mentioned in this article shall be published by the Society in such manner as it sees fit.

Form, manner and content of applications for registration in the Register of Pharmacists or retention in that register

17.—(1) The Council may make such provision in rules in connection with applications for registration in the Register of Pharmacists, or for retention in that register, as it considers appropriate, and may in particular make provision with regard to—

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

(b) the information to be provided by or in respect of the applicant, including—

(i) the name under which he practises or intends to practise, or in the case of a person who does not intend to practise, the name by which he is generally known,

(ii) his home address, and

(iii) the information to be provided for the purposes of determining whether the applicant’s fitness to practise is impaired; and

(c) consultation, as regards the application, with a fitness to practise committee.

(2) The Registrar may—

(a) refuse to register an applicant for entry in the Register of Pharmacists; or

(b) refuse to retain in that register a person who wishes to be retained in that register, and so remove him from it,

if he fails to comply with, or if in respect of him there is a failure to comply with, rules made under paragraph (1).

(3) If a person who is registered in the Register of Pharmacists fails to comply with rules made under paragraph (1) in respect of applications for retention in that register, or there is a failure to comply with such rules in respect of him, the failure may be treated as misconduct for the purposes of article 48(1)(a) and the Registrar shall consider, in accordance with article 49(1), whether or not to refer the matter to the relevant fitness to practise committee.

(4) As regards an exempt person (“E”) who is making an application for entry in the Register of Pharmacists, the Registrar shall accept as sufficient evidence that his fitness to practise is not impaired a document—

(a) to which paragraph (5) applies, as regards his physical or mental health; and

(b) to which paragraph (6) applies, as regards his good character or repute,

if it is presented to the Registrar within the period of three months beginning with its date of issue.

(5) This paragraph applies to a document that attests to E’s good physical and mental health, and—

(a) which is required in E’s relevant European State of origin or the relevant European State from which he comes (“E’s attesting State”), if he wishes to start practising as a pharmacist there; or

(b) if—

(i) no such document as mentioned in sub-paragraph (a) is required in E’s attesting State, and

(ii) rules under paragraph (1) require the presentation of a certificate attesting to an applicant’s good physical and mental health in a particular form,

which is issued by a competent authority in E’s attesting State and which is in a form that corresponds to that particular form.

(6) This paragraph applies to a document that attests to E’s good character or repute—

(a) which is required in E’s attesting State, if he wishes to start practising as a pharmacist there; or

(b) if no such document as mentioned in sub-paragraph (a) is required in E’s attesting State—

(i) containing an extract from the judicial record issued by a competent authority in E’s attesting State, or

(ii) which is a certificate issued by a competent authority in E’s attesting State and which is equivalent to an extract from that State’s judicial record,

unless that document may be or has been revised or rescinded as a consequence of an approach made by the Society to the competent authority which issued it, in accordance with article 8(3) of the Pharmacy Qualifications Directive.

Notification of decisions on applications for entry in the Register of Pharmacists

18.—(1) Where a person applies to have his name registered in the Register of Pharmacists, the Registrar shall, within the specified period, give the applicant notice—

(a) of his decision on the application; and

(b) if he refuses the application, of any right of appeal the applicant has to the Registration Appeals Committee.

(2) In this article, “the specified period” means—

(a) the period of three months beginning with the date on which the Registrar receives the application with full supporting documentation and the relevant fee; or

(b) in the case of an exempt person, such longer period as is permitted by article 12 of the Pharmacy Qualifications Directive.

Relationship between registration in the Register of Pharmacists and membership of the Society

19.  If a person is registered in the Register of Pharmacists, he is a member of the Society, but if he ceases (whether permanently or because his registration is suspended) to be so registered, he also ceases to be a member of the Society.

Offences relating to the Register of Pharmacists

20.—(1) A person commits an offence if—

(a) he falsely represents that—

(i) he is registered in the Register of Pharmacists,

(ii) he is registered in a particular part of the Register of Pharmacists, or

(iii) his registration in the Register of Pharmacists has a particular annotation; or

(b) he uses—

(i) the title “registered pharmacist” without being registered in the Register of Pharmacists, or

(ii) a title in respect of a particular annotation, which is a prescribed specialist title, where he does not have an entry in the Register of Pharmacists with that particular annotation.

(2) For the purposes of paragraph (1)(b)(ii), “prescribed specialist title” means a title for a pharmacist which the Council prescribes as being a title that is only to be used by a registrant with a particular annotation.

(3) A person commits an offence if he practises as a pharmacist whilst being registered in Part 2 of the Register of Pharmacists.

(4) A person who exhibits any certificate purporting to be a certificate of registration issued under—

(a) article 32 in respect of a registered pharmacist but which is not a certificate of registration issued under that article in respect of a registered pharmacist; or

(b) 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,

commits an offence.

(5) If a person—

(a) uses, or lends to or allows to be used by any other person, a certificate of registration in respect of a pharmacist or pharmaceutical chemist (whether issued under article 32 or one of the Pharmacy Acts); or

(b) makes or has in his possession any document closely resembling such a certificate,

for fraudulent purposes, he commits an offence.

(6) Any person who commits an offence under—

(a) paragraph (1) or (3) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale; or

(b) paragraph (4) or (5) shall be liable on summary conviction to a fine not exceeding level 3 on the standard scale.

PART 3 Registration of pharmacy technicians

The Register of Pharmacy Technicians

21.—(1) The Registrar shall establish and maintain in accordance with the provisions of and rules under this Order a register of pharmacy technicians.

(2) The register established and maintained under paragraph (1)—

(a) shall be known as the Register of Pharmacy Technicians; and

(b) shall be divided into two parts, and—

(i) the first part shall be known as “Part 1 – Practising Pharmacy Technicians”, and

(ii) the second part shall be known as “Part 2 – Non-practising Pharmacy Technicians”.

Entitlement to registration in the Register of Pharmacy Technicians

22.—(1) Subject to the provisions of and rules under this Order, a person shall be entitled to be registered in the Register of Pharmacy Technicians if—

(a) he satisfies the Registrar that—

(i) he is appropriately qualified within the meaning given in article 23(1),

(ii) his fitness to practise is not impaired,

(iii) before registration, where necessary, he has met such requirements as to additional education, training or experience as are appropriate to his case, and

(iv) after registration, he meets such requirements as to continuing professional development as are appropriate to his case; and

(b) he has paid any fee prescribed under article 40(1)(a) or (b) that relates to his registration in that register.

(2) A person who is entitled to be registered in the Register of Pharmacy Technicians is to be registered in Part 1 of that register unless he has given to the Society, in the form determined by the Registrar (which may be varied from time to time), an undertaking not to practise in England, Wales, the Channel Islands or the Isle of Man, in which case he is to be registered in Part 2 of that register.

Preregistration requirements for pharmacy technicians in respect of qualifications and additional education, training or experience

23.—(1) For the purposes of article 22(1)(a)(i), a person is “appropriately qualified” if—

(a) he has a qualification awarded in England or Wales which has been approved by the Society as attesting to a standard of proficiency which, in the Society’s opinion, indicates that he has reached an adequate level of understanding for practising as a pharmacy technician;

(b) he is an exempt person and he has a right to practise as a pharmacy technician by virtue of the Second General System Regulations (having successfully completed any adaptation period or aptitude test that he may be required to complete pursuant to those Regulations); or

(c) he has, elsewhere than in England or Wales, undergone training as a pharmacy technician, and—

(i) he holds a qualification which has been approved by the Society as attesting to a standard of proficiency which, in the Society’s opinion, indicates that the person has reached an adequate level of understanding for practising as a pharmacy technician, or

(ii) he holds a qualification which—

(aa) in the case of an exempt person who does not have the right to practise referred to in sub-paragraph (b), taken together with his additional education, training or experience acquired elsewhere than in England or Wales (but at least in part within the European mutual recognition area) indicates, in the Society’s opinion, that he has reached an adequate level of understanding for practising as a pharmacy technician, or

(bb) whether or not he is an exempt person, taken together with his additional education, training or experience that the Society requires him to undertake pursuant to article 22(1)(a)(iii), indicates, in the Society’s opinion, that he has reached an adequate level of understanding for practising as a pharmacy technician,

having successfully completed any adaptation period or aptitude test that he may be required to complete pursuant to the Second General System Regulations.

(2) For the purposes of an application for entry in the Register of Pharmacy Technicians, the Registrar shall not require any exempt person to whom paragraph (1)(b) applies to meet any requirements as to additional education, training or experience, unless—

(a) the application is for restoration to the Register of Pharmacy Technicians; and

(b) in so doing the Registrar is acting in a manner that is consistent with the requirements of the Treaties and the Second General Systems Directive.

(3) In formulating its opinion under paragraph (1)(c) in relation to an exempt person, the Society shall take into account—

(a) if the person holds a qualification granted outside the European mutual recognition area which has been accepted by another relevant European State as qualifying him to practise as a pharmacy technician in that State, the acceptance of that qualification; and

(b) all other qualifications, knowledge and experience, wherever acquired, which are relevant to the determination of the application.

(4) As regards any person to whom paragraph (1)(a) or (c)(i) or (ii)(bb) applies, for the purposes of meeting the requirements of article 22(1)(a)(iii), the Registrar may require him to meet requirements as to additional education which comprise or include reaching an adequate standard of proficiency in the knowledge and use of English, unless he is an exempt person.

General functions of the Society in respect of pharmacy technicians’ and prospective pharmacy technicians’ education, training and the acquisition of experience

24.  The Society shall have the general functions of—

(a) promoting high standards of education and training, and in respect of the acquisition of experience, for pharmacy technicians and prospective pharmacy technicians; and

(b) overseeing all stages of the education, training and acquisition of experience of pharmacy technicians and prospective pharmacy technicians in England and Wales, including—

(i) preregistration education, training and acquisition of experience,

(ii) post-registration education, training and acquisition of experience required for continuing professional development or required for education, training and acquisition of experience in respect of specialisations, and

(iii) education, training and acquisition of experience for persons seeking restoration to the Register of Pharmacy Technicians.

Specific obligations of the Society in respect of pharmacy technicians’ and prospective pharmacy technicians’ education, training and the acquisition of experience

25.  In connection with discharging the functions mentioned in article 24, the Society shall—

(a) determine—

(i) the nature of the knowledge and skills, and

(ii) the nature, extent and content of, and method of assessment for, the education, training and experience,

required for a person qualifying in England and Wales to be considered appropriately qualified for the purposes of article 22(1)(a)(i);

(b) approve qualifications under article 23(1)(a);

(c) approve or accredit programmes or courses of education and training for prospective pharmacy technicians;

(d) determine the arrangements for determining, in accordance with article 23(1)(c)(ii), that a person has reached an adequate level of understanding for practising as a pharmacy technician;

(e) determine assessment arrangements for any additional education, training or experience required for the purposes of article 22(1)(a)(iii); and

(f) determine the nature, extent and content of the education, training, experience and continuing professional development required for the purposes of article 22(1)(a)(iii) and (iv), or for the purposes of obtaining annotations in respect of specialisations, including—

(i) preregistration programmes or courses in respect of, or any combination of, education, training or acquiring experience,

(ii) the amount and type of continuing professional development that registrants are required to undertake,

(iii) they amount and type of education, training and experience required in order to obtain annotations in respect of specialisations,

(iv) education and training to address fitness to practise matters, and

(v) education, training and acquisition of experience in respect of persons seeking restoration to the Register of Pharmacy Technicians or to move from Part 2 to Part 1 of that register.

Specific powers of the Society in respect of pharmacy t