The Pharmacy Order 2010

• Citation: S.I. 2010/231
• Sections: 216

Section 1 Citation and commencement

(1) This Order may be cited as the Pharmacy Order 2010.

(2) The following provisions come into force on the day after the day on which this Order is made—

(a) this article;

(b) articles 2, 3, 4(1), (2), (3)(b), (5) and (8) and 7 and Schedule 1; and

(c) articles 65, 66, 69(1) to (4) and 70 and Schedules 5 and 6.

(3) Except as provided for by paragraph (2), the provisions of this Order which confer powers enabling rules or orders to be made, or which enable standards or requirements to be set by the Council, come into force on the making of this Order, but for the purpose only of the exercise of those powers.

(4) Rules under article 7(1) and (4) are not to come into force before the end of the period of two years beginning with the day on which this Order is made.

(5) Except as provided for by paragraphs (2) and (3), this Order comes into force on such day as the Privy Council may by order appoint.

(6) Different days may be appointed by an order under paragraph (5) for different provisions or different purposes.

Section 2 Extent

(1) Subject to paragraph (2), this Order extends to England and Wales and Scotland.

(2) The extent of any amendment, revocation, repeal or saving of any enactment set out in Schedules 4 and 6 is the same as that of the enactment amended, revoked, repealed or saved.

Section 3 Interpretation

(1) In this Order—

“the 2007 Order” means the Pharmacists and Pharmacy Technicians Order 2007 ;

“ adaptation period ” means—

in the relation to registration as a registered pharmacist under article 20 in reliance on a specified state qualification awarded in Switzerland, a period of supervised practice, subject to an assessment and, where necessary, accompanied by further training or education or both, under the responsibility of a registered pharmacist who is registered in the register by virtue of article 20;

in relation to registration as a registered pharmacist under article 20 in reliance on a specified state qualification awarded otherwise than in Switzerland, a period of supervised practice, subject to an assessment and, where necessary, accompanied by further training, under the responsibility of a registered pharmacist who is registered in the register by virtue of article 20;

in relation to registration as a registered pharmacy technician under article 20 in reliance on a specified state qualification awarded in Switzerland, a period of supervised practice, subject to an assessment and, where necessary, accompanied by further training or education or both, under the responsibility of a registered pharmacist, or a registered pharmacy technician, who is registered in the register by virtue of article 20;

in relation to registration as a registered pharmacy technician under article 20 in reliance on a specified state qualification awarded otherwise than in Switzerland, a period of supervised practice, subject to an assessment and, where necessary, accompanied by further training, under the responsibility of a registered pharmacist, or a registered pharmacy technician, who is registered in the register by virtue of article 20;

“annotation” means an annotation in the Register;

“ aptitude test ” means an assessment with the aim of determining whether a specified state professional has the knowledge, skills and experience that the Council considers requisite for practising as a registered pharmacist or registered pharmacy technician;

“assessment team” means an assessment team appointed under rules made under article 55;

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“controlled drugs” has the meaning given in section 2(1)(a) of the Misuse of Drugs Act 1971 (controlled drugs and their classification);

“the Council” means the General Pharmaceutical Council established by article 4;

“ the Directive ” means Directive 2005/36/EC of the European Parliament and of the Council of 7th September 2005 on the recognition of professional qualifications (OJ No L255, 30.09.2005, p 22), and any reference in this Order to the Directive or to any provision of the Directive is a reference to the Directive, or to that provision, as it had effect immediately before IP completion day;

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“electronic communication” has the meaning given in section 15(1) of the Electronic Communications Act 2000 (general interpretation);

“enactment” means an enactment contained in, or in an instrument made under—

an Act of Parliament;

an Act of the Scottish Parliament; or

a measure or Act of the National Assembly for Wales;

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“improvement notice” means a notice served on any person under article 13;

“individual assessor” means an individual assessor appointed under rules made under article 55;

“inspector” means an inspector appointed by the Council under article 8(1);

“medical device” has the meaning given in regulation 2(2) of the Medical Devices Regulations 2002 ;

“medicinal product” has the same meaning as it has in the Medicines Act 1968 by virtue of section 130 of that Act (meaning of “medicinal product” and related expressions);

“medicinal product on a general sale list” means a medicinal product of a description, or falling within a class, specified in an order which is for the time being in force under section 51 of the Medicines Act 1968 (general sale lists);

“the necessary knowledge of English”—

in relation to a person registered, or applying to be registered, as a pharmacist means a knowledge of English which is necessary for the safe and effective practice as a pharmacist in Great Britain;

in relation to a person registered, or applying to be registered, as a pharmacy technician means a knowledge of English which is necessary for the safe and effective practice as a pharmacy technician in Great Britain;

“the Pharmacy Acts” means the Pharmacy Act 1852 , the Pharmacy Act 1868 , the Pharmacy Act 1908 , the Pharmacy and Poisons Act 1933 and the Pharmacy Act 1954 ;

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“prescribed” means prescribed by rules made by the Council;

“ professional traineeship ” means a period of professional practice, carried out under supervision, that—

constitutes a condition for access to the profession of pharmacist or pharmacy technician in the country in which it is carried out; and

takes place during or after completion of a course of education leading to an educational qualification pursued for the purpose of entry to that profession;

“the Register” means the register established and maintained under article 19;

“registered pharmacist” means a person who is entered in Part 1 ... of the Register;

“registered pharmacy technician” means a person who is entered in Part 2 ... of the Register;

“registered pharmacy” means premises that are entered in Part 3 of the Register;

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

“Registrar”, except where used in the expression “Registrar General”, is to be construed in accordance with article 18(1) and (6);

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“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;

“retail pharmacy business” has the meaning given in section 132 of the Medicines Act 1968 (general interpretation provisions);

“retail sale” is to be construed in accordance with section 131(3) of the Medicines Act 1968 (meaning of “wholesale dealing”, “retail sale” and related expressions);

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

“ specified state professional ” means a person who holds a specified state qualification;

“ specified state qualification ” means a qualification in pharmacy or a pharmacy technician qualification awarded in one of the states specified in Schedule 1 to the Recognition of Professional Qualifications and Implementation of International Recognition Agreements (Amendment) Regulations 2023;

“statutory committees” means the Committees of the Council listed in article 4(6);

“superintendent pharmacist” means a pharmacist who is a superintendent for the purposes of section 71(1) of the Medicines Act 1968 (business carried on by body corporate); and

“supply in circumstances corresponding to retail sale” is to be construed in accordance with section 131(4) of the Medicines Act 1968;

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“ the UK GDPR ” has the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(10) and (14) of that Act) .

(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 purporting to be a pharmacist or a pharmacy technician, that person undertakes any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of healthcare.

(3) For the purposes of articles 34 and 35, “emergency” means an emergency of the type described in subsection (1)(a) of section 19 of the Civil Contingencies Act 2004 (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.

Section 4 The Council and its Committees

(1) There is to be a body corporate known as the General Pharmaceutical Council (“the Council”).

(2) The Council is to be constituted as provided for by an order of the Privy Council made under this article subject to the provisions of Schedule 1 to this Order.

(3) The principal functions of the Council are—

(a) to establish and maintain a register of pharmacists, pharmacy technicians and premises at which a retail pharmacy business is, or is to be, carried on;

(b) to set and promote standards for the safe and effective practice of pharmacy at registered pharmacies;

(c) to set requirements by reference to which registrants must demonstrate that their fitness to practise is not impaired;

(d) to promote the safe and effective practice of pharmacy by registrants (including, for example, by reference to any code of conduct for, and ethics relating to, pharmacy);

(e) to set standards and requirements in respect of the education, training, acquisition of experience and continuing professional development that it is necessary for pharmacists and pharmacy technicians to achieve in order to be entered in the Register or to receive an annotation in the Register and to maintain competence; and

(f) to ensure the continued fitness to practise of registrants.

(4) The Council has the functions conferred on it by this Order and such other functions as may be conferred on it by the Privy Council by order.

(5) Before making an order under paragraph (4), the Privy Council must consult the Council.

(6) The Council must have the following committees—

(a) the Investigating Committee;

(b) the Fitness to Practise Committee; and

(c) the Appeals Committee,

and each of those committees has the functions assigned to it by or under this Order.

(7) The Council may establish such other committees as it considers appropriate in connection with the discharge of its functions and may delegate any of its functions to them, except any power to make rules.

(8) Schedule 1 makes further provision about the Council, its committees, its staff, its publications and its accounts.

Section 5 Standards and requirements: consultation and review

(1) Before setting any standards or requirements under this Order, the Council must consult such persons as it considers appropriate including, where it considers appropriate, persons appearing to it to represent—

(a) registrants;

(b) employers of registrants;

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

(d) users of the services of registrants;

(e) persons or bodies commissioning or funding the services provided by registrants or at registered pharmacies;

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

(g) persons or bodies providing, assessing, regulating or funding education and training for registrants or prospective registrants.

(1A) Before setting any standards under this Order, the Council must consult the Scottish Ministers, the Welsh Ministers and the Secretary of State for Health.

(2) The Council must keep the standards and requirements set under this Order under review and may vary or withdraw any of those standards and requirements whenever it considers it appropriate to do so.

(3) Paragraph (1) applies to the variation or withdrawal of standards or requirements as it applies to the setting of standards or requirements.

Section 6 The Council’s general duties

(1) The over-arching objective of the Council in exercising its functions is the protection of the public.

(1A) The pursuit by the Council of its over-arching objective involves the pursuit of the following objectives—

(a) to protect, promote and maintain the health, safety and well-being of the public;

(b) to promote and maintain public confidence in the professions regulated under this Order;

(c) to promote and maintain proper professional standards and conduct for members of those professions; and

(d) to promote and maintain proper standards in relation to the carrying on of retail pharmacy businesses at registered pharmacies.

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

(a) have proper regard to—

(i) the interests of persons using or needing the services of registrants in Great Britain,

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

(iii) the interests of persons carrying on a retail pharmacy business at a registered pharmacy; and

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

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

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

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

(iv) the regulation of health services, and

(v) the provision, supervision or management of health services.

(3) In carrying out its duty to co-operate under paragraph (2)(b), the Council must have regard to any differing considerations relating to practising as a pharmacist or as a pharmacy technician which apply in England, Scotland or Wales.

(4) In paragraph (2), “other health care professionals” means persons regulated by a body, other than the Council, mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 .

Section 7 Standards: general

(1) In the exercise of its functions under article 4(3)(b), the Council must set standards that are to be met in connection with the carrying on of a retail pharmacy business at or from a registered pharmacy by the person carrying on that business.

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

(3) The standards may, in particular, relate to—

(a) governance arrangements for registered pharmacies, including arrangements for managing and monitoring the safe and effective provision of pharmacy services at or from registered pharmacies;

(b) the working environment at and the condition of registered pharmacies;

(c) the patient and public experience of pharmacy services provided at or from registered pharmacies;

(d) the condition of the equipment and facilities used in the provision of pharmacy services at or from registered pharmacies;

(e) the working environment at and condition of associated premises and the condition of equipment and facilities at associated premises (being premises at which activities are carried on which are integral to the provision of pharmacy services at or from registered pharmacies), but only to the extent appropriate for ensuring the safe and effective provision of pharmacy services at or from registered pharmacies;

(f) training of staff of the retail pharmacy business;

(g) arrangements for ensuring staff of the retail pharmacy business—

(i) have the authority and ability to act to ensure, and

(ii) are properly held accountable for,

the health, safety and well-being of patients to whom pharmacy services are provided at or from registered pharmacies, and of other persons at registered pharmacies.

(4) The Council may make provision in rules—

(a) requiring any person carrying on a retail pharmacy business to provide information to the Council;

(b) for such information to be provided—

(i) at the request of the Council, ...

(ia) on or within a specified period after the occurrence of any event (which includes a decision that an event is to occur) of a description specified in the rules, or

(ii) on such dates or at such intervals as may be specified in the rules or the Council may determine (whether generally, in relation to a description of persons carrying on a retail pharmacy business or in relation to particular persons carrying on such a business); and

(c) in respect of—

(i) the form and manner in which such information is to be provided to the Council, and

(ii) the time within which such information is to be provided to the Council pursuant to a request under sub-paragraph (b)(i).

(5) Rules under paragraph (4) may, in particular, enable the Council to obtain the following information—

(a) details of the person carrying on the retail pharmacy business including—

(i) where the business is carried on by an individual, details of the home address in the Register of that individual,

(ii) where the business is carried on by a partnership, details of the address of the principal office of the partnership and of the names and home addresses of the partners in the partnership,

(iii) where the business is carried on by a body corporate, details of the address of the registered or principal office of the body corporate and of the names and home addresses of its directors;

(b) a list of all premises at which the retail pharmacy business is carried on;

(c) where medicinal products are sold by retail, or supplied in circumstances corresponding to retail sale, at or from premises of a body corporate that is carrying on a retail pharmacy business at or from those premises, the name and home address of the superintendent pharmacist of that business;

(d) details of the type or types of activities undertaken at the premises at which the retail pharmacy business is carried on; and

(e) details of any relevant offence or relevant investigation.

(6) For the purposes of paragraph (5)(e)—

(a) a relevant offence is—

(i) where the retail pharmacy business is carried on by an individual, a criminal offence with which that individual has been charged or for which that individual has been cautioned ,

(ii) where the retail pharmacy business is carried on by a partnership, a criminal offence with which any partner in the partnership or the partnership (whether or not as an entity separate from the partners) has been charged or for which the partner or partnership has been cautioned ,

(iii) where the retail pharmacy business is carried on by a body corporate, a criminal offence with which the body corporate or any of its directors or (if not a director) its superintendent pharmacist has been charged or for which the body corporate, a director or the superintendent pharmacist has been cautioned ,

and a criminal offence is a relevant offence whether or not the charge has resulted in a caution or conviction;

(b) a relevant investigation is an investigation by a licensing, regulatory or other body into the conduct of—

(i) where the retail pharmacy business is carried on by an individual, that individual,

(ii) where the retail pharmacy business is carried on by a partnership, the partnership or any partner in the partnership,

(iii) where the retail pharmacy business is carried on by a body corporate, that body corporate or any director or (if not a director) the superintendent pharmacist of it,

and the reference to details of a relevant investigation includes details of the outcome of that investigation.

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Section 8 The Inspectorate

(1) The Council must establish an inspectorate which is to consist of inspectors appointed by the Council under this paragraph.

(2) An inspector appointed by the Council under paragraph (1) has the following functions—

(a) in connection with the Council’s functions under article 4(3)(b), to enforce such standards as are set under article 7(1);

(b) to assist the Council in its investigation of matters to which Part 6 of this Order applies;

(c) to secure compliance by registrants and by persons carrying on a retail pharmacy business at a registered pharmacy with the provisions of Parts 3 and 4 of the Medicines Act 1968 (which contain provisions about dealings with medicinal products and about pharmacies) in so far as they relate to the sale and supply of medicinal products;

(d) to secure compliance by registered pharmacists and persons carrying on a retail pharmacy business with the provisions of the Poisons Act 1972 and of regulations made under that Act ;

(e) to enforce—

(i) article 38 of this Order, and

(ii) any other provisions of this Order and of rules made under this Order.

(3) An inspector is to hold and vacate office in accordance with the terms of the inspector’s appointment.

(4) The Council may pay to an inspector 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.

Section 9 Inspection and enforcement

(1) The Council must make provision in rules relating to—

(a) the intervals at which inspectors may conduct routine inspections of registered pharmacies; and

(b) the circumstances in which inspectors may conduct special inspections of, and other visits to, registered pharmacies.

(2) Rules under paragraph (1) are not to limit an inspector’s power of entry under article 10.

(3) The Council may, in such manner as it sees fit, publish reports of routine inspections, special inspections and other visits to registered pharmacies by inspectors, and the reports may include an account of the outcomes of those inspections and visits.

(4) If a report that the Council proposes to publish pursuant to paragraph (3) includes personal data, 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 of the personal data is required by paragraph (3) of this article.

(5) In this article, “personal data” has the same meaning as in Parts 5 to 7 of that Act (see section 3(2) and (14) of that Act).

Section 10 Power of entry

(1) An inspector, on producing (if required)—

(a) evidence of the inspector’s identity; and

(b) evidence of the inspector’s appointment,

may, for the purposes of the exercise of a function conferred on the inspector by article 8(2)(a), (b) or (e) enter any registered pharmacy or other premises at any reasonable hour.

(2) In the case of any premises which are or form part of a private dwelling house, an inspector may enter the premises by virtue of paragraph (1) only if 24 hours notice of the intended entry has been given to the occupier.

(3) If a justice of the peace, on sworn information in writing from an inspector, is satisfied that entry to a registered pharmacy or other premises is required for the purposes of the exercise of a function conferred on the inspector by article 8(2)(a), (b) or (e) and is also satisfied that—

(a) admission has been refused, or a refusal is expected, and (in either case) that notice to apply for a warrant has been given to the occupier;

(b) asking for admission, or the giving of such notice, would defeat the object of entry;

(c) the case is one of urgency; or

(d) the premises are unoccupied or the occupier is temporarily absent,

the justice may by signed warrant authorise the inspector to enter the premises, if need be by reasonable force.

(4) A warrant issued by a justice of the peace under paragraph (3) is valid for the period of one month beginning with the day on which the warrant is issued.

(5) An inspector who is authorised to enter any premises by a warrant issued by a justice of the peace under paragraph (3) must, on entering the premises, produce the warrant to any person at the premises appearing to the inspector to be in charge of, or responsible for, the premises or, if the premises are unoccupied, leave a copy of the warrant at the premises.

(6) An inspector entering premises by virtue of this article—

(a) may be accompanied by a police constable or by such other persons as the inspector considers necessary;

(b) may bring into the premises such equipment as the inspector considers necessary.

(7) If an inspector enters any unoccupied premises by virtue of this article, the inspector must leave the premises as effectively secured against unauthorised entry as the premises were found.

(8) In the application of this article to Scotland, a reference to a justice of the peace includes a reference to the sheriff and to a magistrate.

Section 11 Powers of an inspector

(1) An inspector may, upon entering any premises by virtue of article 10 —

(a) inspect the premises and any plant, machinery or equipment at the premises;

(b) search the premises;

(c) inspect and remove from the premises any substance, article or product (whether or not appearing to the inspector to be a medicinal product);

(d) take and remove from the premises samples of any substance, article or product;

(e) carry out any examinations and tests and make any enquiries (including such enquiries of any person as the inspector considers it appropriate to make relating to the fitness to practise of a registrant who is or has been employed on the premises to provide pharmaceutical services);

(f) require any person holding or accountable for any documents or records (whether or not kept at the premises being inspected) to produce them for inspection at the premises.

(2) The power conferred by paragraph (1)(f) includes power to require any documents or records that are kept by means of a computer or other electronic device to be produced in a form in which they are legible and may be taken away.

(3) If an inspector requires documents or records to be produced for inspection by virtue of the power conferred by paragraph (1)(f), the inspector may—

(a) take copies of or extracts from such documents or records;

(b) take possession of the documents or records or of the computer or other electronic device in which the documents or records are stored and retain them for as long as the inspector considers necessary;

(c) require access to any computer or other electronic device or to any associated apparatus or material that is or has been used in connection with the documents or records and inspect and check the operation of the computer, electronic device, apparatus or material.

(4) The power conferred by paragraph (3)(c) includes power to require any person having charge of, or otherwise concerned with the operation of, the computer, device, apparatus or material to afford such assistance as the inspector may reasonably require.

(5) An inspector also has power to do anything which is calculated to facilitate the discharge of the inspector’s functions or which is incidental or conducive to the discharge of those functions.

Section 12 Obstruction: offences

Any person who—

(a) intentionally obstructs an inspector exercising functions under article 10 or 11;

(b) without reasonable cause, fails to give an inspector exercising any functions under this Order any assistance or information that the inspector may reasonably require from that person for the performance of those functions;

(c) furnishes to an inspector exercising any functions under this Order any information that the person knows to be false or misleading; or

(d) fails to produce a document or record when required to do so by an inspector exercising any functions under this Order,

commits an offence and is liable, on summary conviction, to a fine not exceeding level 3 on the standard scale.

Section 13 Improvement notices

(1) If an inspector has reasonable grounds for believing that there is—

(a) a failure in connection with the carrying on of a retail pharmacy business at or from a registered pharmacy entered in the Register under section 74A of the Medicines Act 1968 (registration or premises: Great Britain) to meet the standards that are set under article 7(1); ...

(b) a failure to comply with conditions to which the entry of a registered pharmacy entered in the Register under section 74A of the Medicines Act 1968 is subject by virtue of section 74D(1) of that Act (conditional registration: Great Britain); or

(c) a failure to comply with a requirement contained in any rules made under article 7(4),

the inspector may serve a notice on the person carrying on the retail pharmacy business at or from the registered pharmacy (in this Order referred to as an “improvement notice”).

(2) An improvement notice must—

(a) state the inspector’s grounds for believing that there is a failure referred to in paragraph (1) ;

(b) specify the measures that the person to whom the notice is addressed must take in order to rectify that failure;

(c) require that person to take those measures, or measures that the inspector agrees are at least equivalent to them, within the period specified in the notice which may not be less than 28 days beginning with the day on which the notice is served; and

(d) state—

(i) that there is a right of appeal to a magistrates’ court or to the sheriff under article 16, and

(ii) the period within which such an appeal may be brought.

(3) An improvement notice is served by an inspector—

(a) on an individual—

(i) if it is delivered to that individual personally,

(ii) if it is left at that individual’s proper address, or

(iii) if it is sent by first class post or otherwise delivered to that individual at that individual’s proper address;

(b) on a partnership—

(i) if it is delivered personally to a partner in the partnership,

(ii) if it is delivered personally to a person having control or management of the partnership business, or

(iii) if it is sent by first class post or otherwise delivered to the partnership’s proper address;

(c) on a body corporate—

(i) if it is delivered personally to the secretary or clerk of that body,

(ii) if it is sent by first class post or otherwise delivered to that body’s proper address.

(4) For the purposes of paragraph (3), and of section 7 of the Interpretation Act 1978 (which defines “service by post”) in its application to that paragraph, the proper address of a person is—

(a) in the case of an individual, to that individual’s home address in the Register;

(b) in the case of a partnership, the address of the principal office of the partnership;

(c) in the case of a body corporate, the address of the registered or principal office of the body.

(5) An improvement notice is treated as having been served, where the notice is sent by post, at the time at which the notice would be delivered in the ordinary course of post or, where the notice has been left at an address, it is treated as having been served on the next working day following the day on which it was left at that address.

(6) The Council may make rules providing for an improvement notice which is required to be served on any person under this article to be served by an electronic communication.

(7) Rules under paragraph (6) must secure that—

(a) an improvement notice cannot be served by an electronic communication unless the person consents in writing to the receipt of notices from the Council by electronic communication and the communication is sent to the number or address specified by that person when giving consent;

(b) an electronic communication received outside of a person’s normal business hours is to be taken to have been served on the next working day.

(8) In this article “working day” means a day which is not a Saturday or Sunday, Christmas Day, Good Friday or a day which is a bank holiday under the Banking and Financial Dealings Act 1971 in the part of Great Britain in which the premises to which the notice relates are located.

Section 14 Non-compliance with improvement notices

(1) A person carrying on a retail pharmacy business at or from a registered pharmacy who fails to comply with the terms of an improvement notice served under article 13 commits an offence and is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(1A) But no offence is committed if the failure to comply with the terms of an improvement notice relates to matters included in the improvement notice—

(a) pursuant to article 13(1)(a); or

(b) pursuant to article 13(1)(b), if the failure is to comply with standards set under article 7(1) that the Registrar has made a condition of the entry of the registered premises in the Register pursuant to section 74D of the Medicines Act 1968 (conditional registration: Great Britain).

(2) Where an inspector is reasonably satisfied that a person carrying on a retail pharmacy business at or from a registered pharmacy has failed to comply with the terms of an improvement notice served under article 13, the inspector must give notice of that fact in writing to the Registrar.

(3) The obligation imposed by paragraph (2) applies whether or not proceedings are to be brought against the person for an offence under paragraph (1).

(4) Upon receipt of a notice given under paragraph (2), the Registrar may—

(a) remove the entry of the registered pharmacy from the Register; or

(b) suspend that entry pending compliance by the person with such requirements or conditions as the Registrar considers it necessary to impose.

(4A) But if the failure to comply with terms of the improvement notice relates to matters included in the improvement notice—

(a) pursuant to article 13(1)(a); or

(b) pursuant to article 13(1)(b), if the failure is to comply with standards set under article 7(1) that the Registrar has made a condition of the entry of the registered premises in the Register pursuant to section 74D of the Medicines Act 1968,

the Registrar must instead refer the matter for consideration by the Fitness to Practise Committee under section 80(1)(c) or (1A) of the Medicines Act 1968 (grounds for disqualification in certain cases).

(5) Where under paragraph (4) the Registrar removes or suspends the entry of a registered pharmacy, the Registrar must send to the person carrying on the retail pharmacy business a statement in writing giving that person notice of the removal or suspension and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

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

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

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

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

(7) 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.

(8) For the purposes of paragraph (7), the date of the commission of the offence is the day after the day on which the period specified under paragraph (2)(c) of article 13 expires.

Section 15 Offences committed by partnerships

(1) Proceedings for an offence under article 14 alleged to have been committed by a partnership must be brought in the name of the partnership (and not in that of any of the partners).

(2) Rules of court relating to the service of documents are to have effect as if the partnership were a body corporate.

(3) In proceedings for an offence brought against a partnership, Schedule 3 to the Magistrates’ Courts Act 1980 (corporations) applies as it applies in relation to a body corporate.

(4) A fine imposed on a partnership on its conviction for an offence is to be paid out of the assets of the partnership.

Section 16 Appeals against improvement notices

(1) Any person on whom an improvement notice is served may appeal to a magistrates’ court or, in Scotland, to the sheriff.

(2) The procedure on appeal to a magistrates’ court under paragraph (1) is by way of complaint, and the Magistrates’ Courts Act 1980 applies to the proceedings.

(3) An appeal to the sheriff under paragraph (1) is by summary application.

(4) The period within which an appeal may be brought is 28 days beginning with the date on which the notice was served.

(5) The court may suspend an improvement notice pending the determination or abandonment of an appeal.

Section 17 Powers of a court on appeal

On an appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without modification.

Section 18 The Registrar

(1) The Council must appoint a fit and proper person to be Registrar.

(2) The Registrar is to have such functions as may be conferred by this Order or by rules under this Order or by any other enactment.

(3) The Council may delegate any of its functions to the Registrar, except any power to make rules.

(4) The Council may appoint a Deputy Registrar.

(5) The Registrar and any Deputy Registrar are to hold and vacate office in accordance with the terms of their appointment.

(6) The Registrar may authorise a Deputy Registrar or an employee of the Council to act for the Registrar in any matter.

Section 19 Establishment, maintenance of and access to the Register

(1) The Registrar must establish and maintain a register of pharmacists and pharmacy technicians and, for the purposes of section 74A of the Medicines Act 1968 (registration of premises: Great Britain) and section 74J of that Act (temporary registration with regard to emergencies involving loss of human life or human illness etc.) , premises.

(2) The Register is to be divided into three parts as follows—

(a) Part 1, relating to pharmacists ...;

(b) Part 2, relating to pharmacy technicians ...; and

(c) Part 3, relating to premises;

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

(3) The Council may make such provision in rules in connection with the Register as it considers appropriate and may, in particular, make provision with regard to—

(a) the form and keeping of the Register and the making of entries in, and alterations and corrections to, the Register;

(b) the recording of the date of a registrant’s entry in the Register, or of that of a registered pharmacy, and of the period for which the entry is valid;

(c) the recording of home addresses of registrants;

(d) in any case where a retail pharmacy business carried on at a registered pharmacy is owned by a partnership or a body corporate, the recording of the address of the principal office of the partnership or the address of the registered or principal office of the body corporate;

(e) the recording of qualifications and specialisations of a registrant;

(f) the recording of any specialisations of a retail pharmacy business carried on at a registered pharmacy;

(g) the recording of continuing professional development matters;

(h) the recording of fitness to practise matters, including any warnings or advice given by, or undertakings agreed with, the Investigating Committee or the Fitness to Practise Committee;

(i) the recording of any improvement notices to which a person carrying on a retail pharmacy business at a registered pharmacy is subject;

(j) the recording of any conditions subject to which the entry of a registered pharmacy in the Register has effect; and

(k) the recording of the matters listed in sub-paragraphs (a) to (j), or of any other matters, in the Register in the Welsh language where appropriate.

(4) Rules under paragraph (3) may provide—

(a) for the marking of the Register so as to distinguish those registrants who are entered in Part 1 or 2 of the Register under article 34 from other registrants; and

(b) for the marking of the Register so as to distinguish those registered pharmacies which are entered in Part 3 of the Register under section 74J of the Medicines Act 1968 (temporary registration with regard to emergencies involving loss of human life or human illness etc.) from other registered pharmacies.

(5) The Registrar must, in such manner as the Registrar sees fit, compile lists comprising information in or derived from entries in the Register, but those lists must not include information in or derived from entries in respect of persons or premises whose entry in the Register is suspended.

(6) The Council must determine the information that the lists are to contain, which may include—

(a) a note specifying in which part of the Register a registrant is entered;

(b) the number of the entry of a registrant or of a registered pharmacy;

(c) the area (by reference to a city, town, district or country) in which a registrant lives or in which a registered pharmacy is located and contact details, but a registrant’s home address must not be published without that registrant’s consent;

(d) a note regarding any fitness to practise matters, including—

(i) any conditions to which a registrant’s entry in the Register is subject,

(ii) any warnings or advice given by, or undertakings agreed with, the Investigating Committee or the Fitness to Practise Committee regarding a registrant’s future conduct;

(e) a note in respect of any improvement notices to which a person carrying on a retail pharmacy business at a registered pharmacy is subject;

(f) a note in respect of any conditions subject to which the entry of a registered pharmacy in the Register has effect;

(g) a note in respect of a registrant’s specialisations which are the subject of any annotations;

(h) a note in respect of the specialisations of a retail pharmacy business carried on at a registered pharmacy which are the subject of any annotations;

(i) a note to distinguish those registrants who are entered in Part 1 or 2 of the Register under article 34 from other registrants;

(j) a note to distinguish annotations made in respect of registrants under article 35 from other annotations made in respect of registrants who are qualified to order drugs, medicines and appliances in a specified capacity;

(k) a note to distinguish those registered pharmacies entered in Part 3 of the Register under section 74J of the Medicines Act 1968 (temporary registration with regard to emergencies involving loss of human life or human illness etc.) from other registered pharmacies; and

(l) a note to distinguish annotations made under section 74K of the Medicines Act 1968 (temporary annotations with regard to emergencies involving loss of human life or human illness etc.) from other annotations of entries made in respect of registered pharmacies which are designated as registered pharmacies from which drugs, medicines and appliances may be ordered in a specified capacity.

(7) The Council must publish the lists compiled by the Registrar under paragraph (5) and may do so in such manner as it considers appropriate.

(8) If a registrant’s entry in any part of the Register is suspended, the registrant must be treated as not being entered in that part of the Register, even though that part of the Register still contains the registrant’s name, except—

(a) for the purposes of articles 28 to 31 and 43 and Part 6 (and rules under or that relate to those provisions); and

(b) for such other purposes of this Order as the Council may prescribe.

(9) Accordingly, a person whose entry in any part of the Register is suspended is not to be treated for the purposes of any enactment other than this Order as being entered in that part.

Section 20 Entitlement to entry in Part 1 or 2 of the Register: pharmacists and pharmacy technicians

(1) Subject to the provisions of, and rules under, this Order, a person (“P”) is entitled to be entered in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician if—

(a) the Registrar is satisfied that—

(i) P is appropriately qualified within the meaning given in article 21 or, as the case may be, article 22,

(ii) P’s fitness to practise is not impaired, ...

(iia) P has the necessary knowledge of English; and

(iii) where necessary, P meets such additional requirements (if any) relating to education, training or experience as the Registrar considers are appropriate to P’s case; and

(b) P has paid any fee prescribed under article 36(1)(a).

(2) Subject to the provisions of, and rules under, this Order, a person (“P”) is entitled to have P’s entry in Part 1 or, as the case may be, Part 2 of the Register renewed if—

(a) the Registrar is satisfied that—

(i) P’s fitness to practise is not impaired, and

(ii) P meets the standard of proficiency for the safe and effective practice of pharmacy set under article 43(1) together with such additional requirements (if any) relating to continuing professional development as the Registrar considers are appropriate to P’s case; ...

(iia) P has the necessary knowledge of English; and

(b) P has paid any fee prescribed under article 36(1)(a).

(3) A person is not entitled to be entered in Part 1 or 2 of the Register, or to have an entry in either of those parts renewed, if that person does not intend to practise as a pharmacist or, as the case may be, a pharmacy technician in Great Britain, the Channel Islands or the Isle of Man.

(4) The Registrar must treat a person who—

(a) applies to be entered in Part 1 of the Register as a pharmacist,

(b) qualified as a pharmacist in a relevant European State,

(c) was, on IP completion day, in the register of pharmaceutical chemists for Northern Ireland, or was entered in that register on or after IP completion day further to an application made before IP completion day, and

(d) has remained in that register since IP completion day or, as the case may be, since that entry (disregarding any period in which the person was not in the register as a result of a decision that was later overturned in an appeal or other legal proceeding),

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

Section 20A Article 20: further provision relating to specified state professionals

(1) This article applies where a person holds a specified state qualification which is not a relevant European qualification and wishes to be registered under article 20.

(2) This article does not apply if the qualification held by the person is not a relevant European qualification because Condition 3 in article 21(1G) or, as the case may be, 22(1D) is met in relation to it.

(3) Where this article applies, the Council must specify what aptitude test or adaptation period, or aptitude test and adaptation period, must be passed or successfully completed by the person.

(4) An aptitude test or adaptation period specified under this article, or an aptitude test and adaptation period together specified under this article, must be proportionate to the difference sought to be addressed.

(5) The Council must give a person its reasons for specifying in relation to the person an aptitude test or an adaptation period, or both, if the person makes a written request for them.

(6) Where the Council specifies an aptitude test under this article, the Council must ensure that such aptitude tests are scheduled with reasonable frequency and at least once a year.

Section 21 Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacists

(1) For the purposes of article 20(1)(a)(i), a person (“P”) is “appropriately qualified” as a pharmacist if—

(a) P has a qualification awarded in Great Britain which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register ...;

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

(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . or

(d) ... P has, elsewhere than in Great Britain, undergone training as a pharmacist, and—

(i) holds a qualification which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register, or

(ii) holds a qualification which—

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(bb) ... taken together with the additional education, training or experience that the Registrar requires P to undertake pursuant to article 20(1)(a)(iii), indicates that P has met the standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register.

(1A) A relevant European qualification is to be treated as a qualification which has been approved under paragraph (1)(d)(i).

(1B) In this article and article 20A “ relevant European qualification ” means—

(a) a qualification that falls within article 21A and has not been designated by the Council for the purposes of this sub-paragraph, or

(b) a qualification in pharmacy that does not fall within article 21A but—

(i) was granted in a relevant European State, and

(ii) attests, in the opinion of the Council, to a comparable standard of proficiency to that attested to by a qualification approved under paragraph (1)(a).

(1C) The Council—

(a) may designate a qualification for the purposes of paragraph (1B)(a) only with the approval of the Privy Council;

(b) must maintain and publish a list of the qualifications that are so designated.

(1D) The Council may designate a specified state qualification for the purpose of paragraph (1B)(a), or determine that a specified state qualification is not evidence of having reached a standard of proficiency comparable to that evidenced by a qualification approved under paragraph (1)(a), only where one or more of Conditions 1 to 3 are met.

(1E) Condition 1 is met where there exists a substantial difference between the standard of proficiency evidenced by the specified state qualification and the standard of proficiency for the safe and effective practice that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register.

(1F) Condition 2 is met where the professional activities to which a qualification approved under paragraph (1)(a) relates include one or more professional activities that cover substantially different matters from those covered by the specified state qualification.

(1G) Condition 3 is met where requiring a person who holds a specified state qualification to pass an aptitude test or to successfully complete an adaptation period, or to do both, would amount to requiring the person to acquire a qualification approved under paragraph (1)(a).

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

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

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

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

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

Section 21A European qualifications: pharmacists

(1) Subject to the following provisions of this article, a qualification falls within this article if it was awarded in a relevant European State and is listed in Annex V, point 5.6.2 of the Directive.

(2) A qualification falls within this article only if it is accompanied, where applicable, by the certificate listed in relation to the qualification in the column entitled “Certificate accompanying the diploma” in Annex V, point 5.6.2 of the Directive.

(3) A qualification does not fall within this article if it was awarded before the reference date, or is evidence of training begun before that date.

(4) In paragraph (3) “ reference date ” means the date listed in relation to the State in which the qualification was awarded in the column entitled “Reference date” in Annex V, point 5.6.2 of the Directive.

Section 22 Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacy technicians

(1) For the purposes of article 20(1)(a)(i), a person (“T”) is “appropriately qualified” as a pharmacy technician if—

(a) T has a qualification awarded in Great Britain which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register; or

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

(c) T has, elsewhere than in Great Britain, undergone training as a pharmacy technician, and—

(i) holds a qualification which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register, ...

(ia) holds a qualification which was granted in a relevant European State and, despite its not having been approved under paragraph (i), attests, in the opinion of the Council, to a comparable standard of proficiency to that attested to by a qualification approved under paragraph (1)(a), or

(ii) holds a qualification which—

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(bb) ... taken together with the additional education, training or experience that the Registrar requires T to undertake pursuant to article 20(1)(a)(iii), indicates that T has met the standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register.

(1A) The Council may determine that a specified state qualification is not evidence of having reached a standard of proficiency comparable to that evidenced by a qualification approved under paragraph (1)(a) only where one or more of Conditions 1 to 3 are met.

(1B) Condition 1 is met where there exists a substantial difference between the standard of proficiency evidenced by the specified state qualification and the standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register;

(1C) Condition 2 is met where the professional activities to which a qualification approved under paragraph (1)(a) relates include one or more professional activities that cover substantially different matters from those covered by the specified state qualification.

(1D) Condition 3 is met where requiring a person who holds a specified state qualification to take an aptitude test or to successfully complete an adaptation period, or to do both, would amount to requiring the person to acquire a qualification approved under paragraph (1)(a).

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

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

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

Section 23 Form, manner and content of applications for entry or for renewal of an entry in the Register: pharmacists and pharmacy technicians

(1) Subject to paragraphs (1A) and (1B), the Council may make such provision in rules as it considers appropriate in connection with applications for entry, or for the renewal of an entry, in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician 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 must apply using application forms and presenting certificates that are in such form as the Council may determine from time to time);

(b) the time prior to an entry ceasing to be valid by which an application for the renewal of the entry must have been received by the Registrar;

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

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

(ii) the applicant’s home address,

(iii) where the applicant is a national of the United Kingdom ..., proof of nationality and ;

(iv) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

(vi) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) consultation about the application with the Fitness to Practise Committee or the Investigating Committee.

(1A) Where the applicant holds a specified state qualification, the documentary and other evidence which is required to accompany applications of the kind mentioned in paragraph (1) must be no more than is necessary to demonstrate to the Registrar that the applicant satisfies the conditions set out in article 20(1).

(1B) Where the applicant holds a specified state qualification, the Council must accept certified copies of documents in place of original documents, unless it requires original documents to protect the integrity of the application process.

(1C) For the purposes of paragraph (1B), a certified copy of a document is one which is certified to be a true copy of the original by a solicitor practising in any part of the United Kingdom.

(2) The Registrar may, in relation to an applicant—

(a) refuse to enter the applicant in the Register; or

(b) refuse to renew the entry of the applicant in the Register,

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

(3) If a registrant fails to comply with rules made under paragraph (1) in respect of an application for the renewal of an entry relating to the registrant in the Register, the failure may also 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) to the Fitness to Practise Committee.

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

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

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

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

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

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

(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 23A Supplementary provisions as to necessary knowledge of English

(1) The Council must publish guidance about—

(a) the evidence, information or documents to be provided by an applicant for the purpose of satisfying the Registrar under article 20(1)(a)(iia) or (2)(a)(iia) that the applicant has the necessary knowledge of English; and

(b) the process by which the Registrar is to determine whether the Registrar is satisfied as mentioned in paragraph (a).

(2) The Registrar must have regard to the guidance published under paragraph (1) in determining whether the Registrar is satisfied as mentioned in paragraph (1)(a).

(3) Paragraphs (4) and (6) apply if, having considered any evidence, information or documents provided by the applicant in support of the applicant’s application, the Registrar is not satisfied under article 20(1)(a)(iia) or (2)(a)(iia) that the applicant has the necessary knowledge of English.

(4) The Registrar may request the applicant to provide further evidence, information or documents within such period as the Registrar may specify.

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

(6) The Registrar may require the applicant—

(a) to undergo an examination or other assessment; and

(b) to provide information in respect of that examination or assessment,

within such period as the Registrar may specify.

(6A) Where the Registrar requires a specified state professional to undergo an examination or other assessment, the examination or assessment must be proportionate to the level of English required to satisfy the Registrar under this article.

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

(8) Guidance published under paragraph (1) may make different provision in relation to different cases or classes of case.

(9) Before issuing such guidance, or varying or withdrawing it, the Council must consult such persons or organisations as it considers appropriate, including, where it considers appropriate, persons appearing to it to represent the organisations specified in article 5(1)(a) to (g).

(10) In this article, references to an applicant are references to a person applying under article 23 for entry or renewal of entry in Part 1 of the Register as a pharmacist, or in Part 2 of the Register as a pharmacy technician.

Section 24 Notification by the Registrar: entry and renewal

(1) Paragraphs (2) to (4) apply where a person (“A”) applies under article 23 for entry in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician.

(2) The Registrar must, within the period of one month beginning with the date of receipt of the application—

(a) acknowledge receipt of the application; and

(b) inform A of any missing document required for the purposes of the application.

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

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

(2C) Where A holds a specified state qualification, the Registrar must—

(a) give A adequate time to complete the requirements and procedures of the application process; and

(b) deal promptly with A’s application.

(3) The Registrar must, within the relevant period , notify A—

(a) of the result of the application; and

(b) if the Registrar refuses the application, of the reasons for the refusal, and of any right of appeal that A has to the Appeals Committee under article 40.

(4) Any failure by the Registrar to inform A of—

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

(b) the result of the application as required by paragraph (3)(a),

is to constitute ... a decision by the Registrar to refuse the application ... which is to be taken as having been made at the end of the relevant period .

(4A) For the purposes of this article, the relevant period is:

(a) where A holds a specified state qualification, the period of four months beginning with the relevant date;

(b) in any other case, the period of three months beginning with that date.

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

(5A) In calculating the relevant period , the following are to be disregarded—

(a) any period which begins on the date on which the Registrar makes a request under article 23A(4) and ends on the date on which A complies with the request; or

(b) any period which begins on the date on which the Registrar requires the applicant to undergo an examination or other assessment under article 23A(6)(a) and ends on the date on which the applicant complies with the requirement under article 23A(6)(b).

(6) Paragraphs (7) to (9) apply where a person (“A”) applies under article 23 for the renewal of an entry in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician.

(7) The Registrar must, within the period of one month beginning with the date of receipt of the application—

(a) acknowledge receipt of the application; and

(b) inform A of any missing document required for the purposes of the application.

(8) The Registrar must, within the specified period, notify A—

(a) of the result of the application; and

(b) if the Registrar refuses the application, of the reasons for the refusal and of any right of appeal that A has to the Appeals Committee under article 40.

(9) Any failure by the Registrar to inform A of the result of the application as required by paragraph (8)(a) is to constitute a decision by the Registrar to refuse the application which is to be taken as having been made at the end of the specified period.

(10) In paragraphs (8) and (9) “the specified period” means the period of one month beginning with the relevant date.

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

(a) the date on which the Registrar receives the application; or

(b) if any document required for the purposes of the application, or any fee which is payable in respect of that application by virtue of rules made under article 36(1)(a) (“the relevant fee”), is missing when the Registrar first receives the application, the date on which the Registrar first has all the documents required for those purposes together with the relevant fee.

(12) A document that is requested or required under article 23A(4) or (6)(b) is not to be treated as missing for the purposes of this article.

Section 25 Duration of entry

(1) The entry of a person entered in Part 1 or 2 of the Register pursuant to an application under article 23 is valid for the period of one year beginning with the date on which the entry was made.

(2) Each renewal of such an entry pursuant to a further application under that article extends the validity of the entry for the period of one year beginning with the relevant date.

(3) If the entry of a person in Part 1 or 2 of the Register ceases to be valid under this article then, except in such circumstances as may be prescribed, that person is to be treated for all purposes as no longer being entered in that part of the Register and accordingly the Registrar must remove the entry from the Register.

(4) Where the Registrar removes the entry of a person from the Register under paragraph (3), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it.

(5) In paragraph (2) the “relevant date”—

(a) on the first renewal of an entry, means the first anniversary of the date on which the entry was made;

(b) on a subsequent renewal of an entry, means the anniversary of the date on which the entry was made that occurs next after the making of the application for renewal.

Section 26 Notice of entry in the Register

(1) Subject to paragraph (3), the Registrar must, where requested to do so by a registrant (other than one entered in the Register under article 34), or where an application for entry in the Register as a pharmacist or a pharmacy technician, or for the renewal of such an entry, is granted, issue to the registrant free of charge written notice of that registrant’s entry in the Register.

(2) Notice of a registrant’s entry in the Register issued under this article must be in such form as the Council determines from time to time and must include—

(a) the number of the entry;

(b) the period in respect of which the entry is valid;

(c) the part of the Register in which the registrant is entered.

(3) The Registrar is not under a duty to issue further notice of a registrant’s entry in the Register to a person to whom such notice has already been issued (“R”), whether under this article, article 32 of the 2007 Order, or one of the Pharmacy Acts, unless R—

(a) satisfies the Registrar that the original notice, and any further notice already issued, has been lost or destroyed; or

(b) changes the name under which R practises,

and pays to the Council any fee in respect of the further notice prescribed under article 36(1)(f).

(4) The Council may make such provision in rules as it considers appropriate in connection with the return of notices of a registrant’s entry in the Register which—

(a) incorrectly state the part of the Register in which the registrant is entered; or

(b) incorrectly state the name under which the registrant practises.

Section 27 Specialisations: registrants and registered pharmacies

(1) The Council may make such provision in rules as it considers appropriate in connection with annotations to entries in the Register to denote specialisations, and may in particular make provision with regard to—

(a) the type of specialisations that are to be subject to annotations;

(b) the form and manner in which applications for entering, renewing or restoring annotations in respect of specialisations, or for the removal of such annotations, 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);

(c) the circumstances in which annotations in respect of specialisations are to be entered, renewed, restored or removed by the Registrar;

(d) the removal of annotations in respect of specialisations by the Registrar where a prescribed fee in respect of the renewal of the annotation has not been paid, after such warnings as may be prescribed;

(e) the standards of proficiency for the safe and effective practice of pharmacy that it is necessary for a registrant to achieve in order for an annotation in respect of a specialisation to be made to an entry in the Register of a registrant; and

(f) the standards provided for in rules made under article 7(1) that it is necessary to meet in connection with the carrying on of a retail pharmacy business at a registered pharmacy in order for an annotation in respect of a specialisation of the retail pharmacy business to be made to the entry in the Register of the registered pharmacy.

(2) Where the Registrar decides not to enter, renew or restore an annotation in respect of a specialisation of an entry in the Register of a registrant, or to remove such an annotation from the Register, the Registrar must send to that person at that person’s last known home address 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.

(3) Where the Registrar decides not to enter, renew or restore an annotation in respect of a specialisation of an entry in the Register of a registered pharmacy, or to remove such an annotation from the Register, the Registrar must send to the person 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.

(4) The notice under paragraph (3) must be sent—

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

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

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

Section 28 Registrants’ duties with regard to their entries

(1) The Council may make such provision in rules as it considers appropriate in connection with the information to be provided by registrants with regard to their entries in Part 1 or 2 of the Register (provided the rules are consistent with paragraph (2)) and may, in particular, make provision with regard to the obligations of a registrant (“R”) to inform the Registrar—

(a) of the name under which R practises and of any changes to that name; and

(b) of R’s home address and of any changes to it.

(2) If the Registrar—

(a) sends by first class post to R a notice addressed to R at R’s last known home address enquiring whether R has—

(i) changed the name under which R practises,

(ii) ceased to practise as a pharmacist or, as the case may be, a pharmacy technician and intends to apply under article 31 for voluntary removal from the Register, or

(iii) changed home address,

and receives no reply within a period of one month beginning on the day of posting the notice; and

(b) upon the expiration of that period sends to R a second similar notice and receives no reply within one month beginning on the day of posting the notice,

the Registrar may remove R’s entry from Part 1 or, as the case may be, Part 2 of the Register.

(3) If a registrant entered in Part 1 or 2 of the Register fails to comply with rules made under paragraph (1), the Registrar may remove the entry of that registrant from that part of the Register.

(4) Where the Registrar removes the entry of a person from a part of the Register pursuant to paragraph (2) or (3), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Section 29 Corrections to the Register

(1) The Registrar must keep the Register correct and up to date, and, in so doing—

(a) must remove from the Register the entry of any registrant who has died; and

(b) from time to time, must make the necessary alterations—

(i) to any of the particulars in a registrant’s entry, and

(ii) to any of the particulars in the entry of a registered pharmacy.

(2) On registering the death of a registrant—

(a) in England and Wales, a registrar of births and deaths; or

(b) in Scotland, a district registrar,

must, without charge, send forthwith to the Registrar a certified copy of the entry in the register of deaths relating to the death.

(3) If the Registrar determines—

(a) that a entry of a registrant in Part 1 or 2 of the Register (except in a case where the entry was made under article 34) ... has been fraudulently procured or incorrectly made, or

(b) that the entry of a registered pharmacy in Part 3 of the Register has been fraudulently procured or incorrectly made,

the Registrar may remove the registrant or registered pharmacy from that part of the Register.

(4) The Council may make such provision in rules as it considers appropriate in connection with determinations by the Registrar under paragraph (3).

(5) Where the Registrar removes the entry of a person from a part of the Register pursuant to paragraph (3)(a), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(6) Where the Registrar removes the entry of a registered pharmacy from Part 3 of the Register pursuant to paragraph (3)(b), the Registrar must send to the person carrying on a retail pharmacy business at the registered pharmacy a statement in writing giving that person notice of the removal 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 retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the Register;

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

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

Section 30 Fitness to practise matters before entry or renewal of an entry

(1) The Registrar may remove the entry of a registrant from Part 1 or 2 of the Register if it is shown to the satisfaction of the Registrar that—

(a) the fitness to practise of the registrant was impaired as a result of prescribed circumstances or because of a problem with the registrant’s physical or mental health—

(i) at the time of the registrant’s entry in that part of the Register, or

(ii) at the time of an application to renew the registrant’s entry in that part of the Register; and

(b) the registrant had not informed the Registrar of those circumstances or that problem before the time mentioned in paragraph (a)(i) or (ii).

(2) For the purposes of paragraph (1), the Council may make such provision in rules as it considers appropriate in connection with the information to be provided to the Registrar by or in respect of a registrant for the purpose of determining whether the registrant’s fitness to practise was so impaired.

(3) If a registrant fails to comply, or if in respect of a registrant there is a failure to comply, with rules made under paragraph (2), the Registrar may remove the entry of that registrant from the part of the Register concerned.

(4) The Council may make such provision in rules as it considers appropriate in connection with the procedure to be followed by the Registrar before removing the entry of a registrant from Part 1 or 2 of the Register pursuant to paragraph (1) or (3).

(5) Where the Registrar removes the entry of a person from Part 1 or 2 of the Register pursuant to paragraph (1) or (3), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Section 31 Voluntary removal from the Register

(1) The Council may make such provision in rules as it considers appropriate in connection with applications by registrants for voluntary removal of an entry from any part of the Register 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 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;

(c) fitness to practise matters;

(d) refusal of applications (in such circumstances as may be prescribed in the rules including where there are outstanding fitness to practise proceedings in respect of the applicant).

(2) Where the Registrar refuses an application for voluntary removal from any part 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 refusal and of the reasons for it.

Section 32 Indemnity arrangements

(1) A registrant who practises as a pharmacist or pharmacy technician must have in force an indemnity arrangement which provides appropriate cover in relation to that registrant in respect of liabilities which may be incurred in practising as such.

(2) For the purposes of this article, an “indemnity arrangement” may comprise—

(a) a policy of insurance;

(b) an arrangement made for the purposes of indemnifying a person;

(c) a combination of the two.

(3) For the purposes of this article, “ appropriate cover ”, in relation to practice as a pharmacist or pharmacy technician, means cover against liabilities that may be incurred in practising as such which is appropriate, having regard to the nature and extent of the risks of practising as such.

(4) The Council may make rules in connection with the information to be provided to the Registrar—

(a) by or in respect of any person seeking to be entered in any part of the Register as a pharmacist or pharmacy technician (including an application for restoration) for the purposes of determining whether if that person is so entered, there will be in force in relation to that person by the time that person begins to practise an indemnity arrangement which provides appropriate cover; and

(b) by or in respect of a registrant for the purposes of determining whether, at any time, there is in force an indemnity arrangement which provides appropriate cover in relation to that registrant.

(5) Rules under paragraph (4)(b) may require information to be provided—

(a) at the request of the Registrar; or

(b) on such dates or at such intervals as the Registrar may determine, either generally or in relation to individual registrants or registrants of a particular description.

(6) The Council may also make rules requiring a registrant to inform the Registrar if there ceases to be in force in relation to that registrant an indemnity arrangement which provides appropriate cover.

(7) The Council may also make rules requiring a registrant to inform the Registrar if there is in force in relation to that registrant appropriate cover provided under an indemnity arrangement by an employer.

(8) Where there is a failure to comply with the rules under paragraph (4) by or in respect of a person who is entered, or who is seeking to be entered, in any part of the Register, the Registrar may refuse to enter the person in, or to restore the person's entry to, or to renew the person's entry for, that part of the Register.

(9) If a registrant is in breach of paragraph (1), or fails to comply with rules under paragraph (4)(b), (6) or (7), or there is a failure to comply with rules under paragraph (4)(b) in respect of a registrant—

(a) the Registrar may remove that person's entry from Part 1 or 2 of the Register (as the case may be); or

(b) the breach or failure 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) to the Fitness to Practise Committee.

(10) Where the Registrar—

(a) refuses to enter a person in any part of the Register, or to restore a person's entry to any part of the Register pursuant to paragraph (8); or

(b) removes a person's entry from any part of the Register, pursuant to paragraph (9)(a),

the Registrar must send to the person at the person's last known address a statement in writing giving the person notice of the decision and the reasons for it and the right of appeal to the Appeals Committee under article 40.

(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 33 Visiting pharmacists and pharmacy technicians from relevant European States

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

Section 33A European professional card

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

Section 34 Temporary entry with regard to emergencies involving loss of human life or human illness etc.

(1) If the Secretary of State advises the Registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this article, the Registrar may enter in Part 1 or 2 of the Register—

(a) a person as a pharmacist or a pharmacy technician if the Registrar considers that the person is a fit, proper and suitably experienced person to be so entered in the Register with regard to the emergency; or

(b) the persons comprising a specified group of persons as pharmacists or, as the case may be, pharmacy technicians if the Registrar considers that the group is comprised of persons who may reasonably be considered fit, proper and suitably experienced persons to be so entered in the Register with regard to the emergency.

(2) The Registrar may enter in Part 1 or Part 2 of the Register by virtue of paragraph (1)(b) all of the persons comprising a specified group of persons without first identifying each person in the group.

(3) The entry of a person in Part 1 or 2 of the Register under this article is subject to such conditions as the Registrar may specify, and the Registrar may at any time vary the conditions to which a person’s entry under this article is subject (including by adding to the conditions or removing any conditions).

(4) The entry of any person in Part 1 or 2 of the Register by virtue of paragraph (1)(b) as one of a specified group may be subject to the same conditions as the entries of other members of the group or it may be subject to different conditions.

(5) The entry of a person in Part 1 or 2 of the Register under this article ceases to have effect if revoked by the Registrar, which—

(a) the Registrar must do if the Secretary of State advises the Registrar that the circumstances that led the Secretary of State to advise the Registrar as mentioned in paragraph (1) no longer exist;

(b) the Registrar may do for any other reason at any time including where the Registrar has grounds for suspecting that the person’s fitness to practise may be impaired.

(6) The entry of a person in Part 1 or 2 of the Register by virtue of paragraph (1)(b) as one of a specified group may be revoked without revoking the entries of the other members of the group, or it may be revoked by virtue of a decision to revoke the entries of all the members of the group.

(7) Articles 20 to 25, 27 and 30, Part 5 and Part 6 (except articles 48 to 50) do not apply to persons entered in Part 1 or 2 of the Register under this article.

(8) If a person breaches any condition to which the person’s entry in Part 1 or 2 of the Register under this article is subject, anything done by that person in breach of the condition is to be treated as not being done by a registered pharmacist or, as the case may be, by a registered pharmacy technician.

(9) The Registrar may make available information to assist with the identification of persons entered in Part 1 or 2 of the Register under this article in such manner as the Registrar sees fit.

Section 35 Temporary annotations with regard to emergencies involving loss of human life or human illness etc.

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

(a) the entry of a registrant in Part 1 or 2 of the Register to indicate that the registrant is qualified to order drugs, medicines and appliances in a specified capacity, notwithstanding that the registrant is not so qualified, if the Registrar considers that the registrant is a fit, proper and suitably experienced person to order drugs, medicines and appliances in that capacity with regard to the emergency; or

(b) the entries of a specified group of registrants in Part 1 or 2 of the Register to indicate that they are qualified to order drugs, medicines and appliances in a specified capacity, notwithstanding that they are not so qualified, if the Registrar considers that the group is comprised of registrants who are of a type who may reasonably be considered fit, proper and suitably experienced persons to order drugs, medicines and appliances in that capacity with regard to the emergency.

(2) The Registrar may make the annotation in such a way as to distinguish registrants whose entries are annotated by virtue of paragraph (1) from registrants in respect of whose entries the annotation is made otherwise than by virtue of paragraph (1).

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

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

(b) may be removed by the Registrar at any time, including where the Registrar has grounds for suspecting that the person’s fitness to order drugs, medicines and appliances may be impaired.

(4) A registrant whose entry in Part 1 or 2 of the Register is annotated by virtue of paragraph (1)(b) as one of a specified group may have that annotation removed without the Registrar removing the equivalent annotations of the other members of the group or by virtue of a decision to remove the annotations made by virtue of paragraph (1)(b) of all the members of the group.

Section 36 Fees in connection with entry

(1) The Council may make rules with respect to the charging of fees in connection with the entry in the Register of a person or of premises at which a retail pharmacy business is, or is to be, carried on, and in particular with respect to—

(a) applications for entry to, or for the renewal of an entry in, the Register of a person or premises under article 23 or, as the case may be, under section 74A of the Medicines Act 1968 (registration of premises: Great Britain);

(b) applications for the restoration of an entry to the Register pursuant to—

(i) article 37 (including provision for additional fees to be charged in connection with the application) ,

(ii) article 57,

(iii) under section 74C(1) of the Medicines Act 1968 (supplementary provision in respect of registration of premises: Great Britain), and

(iv) section 74I(1) of the Medicines Act 1968 (supplementary provision in respect of change of ownership of retail pharmacy business: Great Britain);

(c) amendments to the Register (including any amendments required to reflect the transfer of ownership of the retail pharmacy business carried on at a registered pharmacy or the voluntary removal of a registered pharmacy from the Register);

(d) applications for entering annotations in, or restoring annotations to, the Register;

(e) applications for the renewal of annotations in the Register; and

(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;

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

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

Section 36A Additional requirements for specified state professionals

Any fee prescribed by the Council under article 36(1) in connection with the making of an entry in the register relating to a specified state professional must be—

(a) reasonable and proportionate to the cost of dealing with such an applicant’s application;

(b) transparent, and made public in advance; and

(c) payable by electronic means through the Council’s website.

Section 37 Restoration to the Register of persons or premises removed from the Register

(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);

(c) pursuant to article 29(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 (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

(c) in the case of applications for restoration made in respect of individuals—

(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.

Section 38 Offences relating to the Register

(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

(c) entered in any part of the Register with a particular annotation,

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.

Section 39 Appealable decisions

(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);

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

(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 (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 (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).

Section 40 Appeals to the Appeals Committee

(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

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

(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.

Section 41 Appeals from the Appeals Committee

(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 ...;

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

(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.

Section 42 Education, training and acquisition of experience

(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).

Section 42A Professional traineeships carried out in other relevant European States, etc.

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

Section 43 Continuing professional development

(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;

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

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 44 Specific obligations and powers of the Council in respect of education and training

(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.