The Pharmacy Order 2010
| Year | 2010 |
2010 No. 231
Health Care And Associated Professions
The Pharmacy Order 2010
Made 10th February 2010
Coming into force in accordance with article 1
At the Court at Buckingham Palace, the 10th day of February 2010
Present,
The Queen’s Most Excellent Majesty in Council
This Order in Council is made in exercise of the powers conferred by sections 60 and 62(4) and (4A) of, and Schedule 3 to, the Health Act 19991as read with paragraph 1A of Schedule 2 to the European Communities Act 19722.
This Order makes provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to Her Majesty, with the advice of Her Privy Council, that it is necessary for the reference to Directive 2005/36/ECof the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications3to be construed as a reference to that Directive as amended from time to time.
The Secretary of State and the Scottish Ministers published a draft Order and invited representations as required by paragraph 9(1) and (3) of Schedule 3 to the Health Act 1999.
The period of three months mentioned in paragraph 9(4) of that Schedule expired before a draft of this Order in Council was laid before Parliament and the Scottish Parliament.
A draft of this Order in Council has been approved by resolution of each House of Parliament and the Scottish Parliament in accordance with section 62(10) of the Health Act 1999.
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)
(a) this article;
(b)
(b) articles 2, 3, 4(1), (2), (3)(b), (5) and (8) and 7 and Schedule 1; and
(c)
(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.
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 20074;
“annotation” means an annotation in the Register;
“assessment team” means an assessment team appointed under rules made under article 55;
“competent authority” means any authority or body of a relevant European State designated by that State for the purposes of the Directive as competent, in connection with practice as a pharmacist or pharmacy technician—
(a) to receive or issue evidence of qualifications or other information or documents; and
(b) to receive applications and take the decisions referred to in the Directive;
“controlled drugs” has the meaning given in section 2(1)(a) of the Misuse of Drugs Act 19715(controlled drugs and their classification);
“the Council” means the General Pharmaceutical Council established by article 4;
“the Directive” means Directive 2005/36/ECof the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications6, and references in this Order to the Directive, or to any provision of the Directive, are references to the Directive, or to that provision, as amended from time to time;
“electronic communication” has the meaning given in section 15(1) of the Electronic Communications Act 20007(general interpretation);
“enactment” means an enactment contained in, or in an instrument made under—
(a) an Act of Parliament;
(b) an Act of the Scottish Parliament; or
(c) a measure or Act of the National Assembly for Wales;
“European mutual recognition area” means the territory of the EEA States8and Switzerland;
“exempt person” means—
(a) a national of a relevant European State other than the United Kingdom;
(b) a national of the United Kingdom who is seeking access to, or is pursuing, the profession of pharmacist or pharmacy technician by virtue of an enforceable Community right; or
(c) a person who is not a national of a relevant European State but who is, by virtue of an enforceable Community right, entitled to be treated, for the purposes of access to and pursuit of the profession of pharmacist or pharmacy technician, no less favourably than a national of a relevant European State;
“General Systems Regulations” means the European Communities (Recognition of Professional Qualifications) Regulations 20079;
“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 200210;
“medicinal product” has the same meaning as it has in the Medicines Act 1968 by virtue of section 130 of that Act11(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 196812(general sale lists);
“the Pharmacy Acts” means the Pharmacy Act 185213, the Pharmacy Act 186814, the Pharmacy Act 190815, the Pharmacy and Poisons Act 193316and the Pharmacy Act 195417;
“the Poisons Rules” means rules made by the Secretary of State under section 7 of the Poisons Act 197218(poisons rules);
“prescribed” means prescribed by rules made by the Council;
“the Register” means the register established and maintained under article 19;
“registered pharmacist” means a person who is entered in Part 1 or 4 of the Register;
“registered pharmacy technician” means a person who is entered in Part 2 or 5 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);
“Registrar General” means—
(a) the Registrar General for England and Wales appointed under section 1 of the Registration Service Act 195319(Registrar General); or
(b) the Registrar General for Scotland appointed under section 1(1) of the Registration of Births, Deaths and Marriages (Scotland) Act 196520(the Registrar General);
“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 196821(general interpretation provisions);
“retail sale” is to be construed in accordance with section 131(3) of the Medicines Act 196822(meaning of “wholesale dealing”, “retail sale” and related expressions);
“the Society” means the Royal Pharmaceutical Society of Great Britain;
“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 196823(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.
(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 200424(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)
(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)
(b) to set and promote standards for the safe and effective practice of pharmacy at registered pharmacies;
(c)
(c) to set requirements by reference to which registrants must demonstrate that their fitness to practise is not impaired;
(d)
(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...
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