Legalize / United Kingdom / Statutory-Instrument

The Pharmacy Order 2010

Type Statutory-Instrument

Publication 2010-02-10

Last updated 2026-01-07

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 10th February 2010

Coming into force in accordance with article 1

At the Court at Buckingham Palace, the 10th day of February 2010Present,The Queen’s Most Excellent Majesty in Council

Accordingly, Her Majesty is pleased, by and with the advice of Her Privy Council, to make the following Order in Council:

PART 1 — Preliminary

Citation and commencement

1

(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

(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.

Extent

2

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repeal or saving of any enactment set out in Schedules 4 and 6 is the same as that of the enactment amended, revoked, repealed or saved.

Interpretation

3

(1) In this Order—

“the 2007 Order” means the Pharmacists and Pharmacy Technicians Order 2007[^f00004];

“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;

“controlled drugs” has the meaning given in section 2(1)(a) of the Misuse of Drugs Act 1971[^f00005] (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;

“electronic communication” has the meaning given in section 15(1) of the Electronic Communications Act 2000[^f00007] (general interpretation);

“enactment” means an enactment contained in, or in an instrument made under—an Act of Parliament;an Act of the Scottish Parliament; ora measure or Act of the National Assembly for Wales;

“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[^f00010];

“medicinal product” has the same meaning as it has in the Medicines Act 1968 by virtue of section 130 of that Act[^f00011] (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 ^f00012;

“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[^f00013], the Pharmacy Act 1868[^f00014], the Pharmacy Act 1908[^f00015], the Pharmacy and Poisons Act 1933[^f00016] and the Pharmacy Act 1954[^f00017];

“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; andtakes 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);

“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[^f00021] (general interpretation provisions);

“retail sale” is to be construed in accordance with section 131(3) of the Medicines Act 1968[^f00022] (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[^f00023] (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;

“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[^f00024] (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.

PART 2 — The Council and its Committees

The Council and its Committees

4

(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

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.

Standards and requirements: consultation and review

5

(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;

(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.

The Council’s general duties

6

(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;

(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[^f00025].

PART 3 — Registered Pharmacies: Standards in retail pharmacies

Standards: general

7

(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;

(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

(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.

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

The Inspectorate

8

(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[^f00027] (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[^f00028] 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.

Inspection and enforcement

9

(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).

Power of entry

10

(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;

(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.

Powers of an inspector

11

(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.

Obstruction: offences

12

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.

Improvement notices

13

(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)[^f00029] of that Act (conditional registration: Great Britain); or

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;

(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[^f00030] (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;

(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[^f00031] in the part of Great Britain in which the premises to which the notice relates are located.

Non-compliance with improvement notices

14

(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.

Offences committed by partnerships

15

(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[^f00032] (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.

Appeals against improvement notices

16

(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.

Powers of a court on appeal

17

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

PART 4 — Registration

The Registrar

18

(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.

Establishment, maintenance of and access to the Register

19

(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.)[^f00033], 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

(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;

(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[^f00034] 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[^f00035] (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.

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

20

(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).

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

21

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

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

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

22

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

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

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

23

(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;

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

Notification by the Registrar: entry and renewal

24

(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.

Duration of entry

25

(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.

Notice of entry in the Register

26

(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;

(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.

Specialisations: registrants and registered pharmacies

27

(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.

Registrants’ duties with regard to their entries

28

(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.

Corrections to the Register

29

(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.

Fitness to practise matters before entry or renewal of an entry

30

(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.

Voluntary removal from the Register

31

(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;

(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.

Indemnity arrangements

32

(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;

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

Visiting pharmacists and pharmacy technicians from relevant European States

33

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

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

34

(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.

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

35

(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.

Fees in connection with entry

36

(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[^f00036] (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[^f00037] (supplementary provision in respect of registration of premises: Great Britain), and

(iv) section 74I(1) of the Medicines Act 1968[^f00038] (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

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