SI 2010/231 Page 1 2010 No. 231 HEALTH CARE AND ASSOCIATED PROFESSIONS The Pharmacy Order 2010 Thomson Reuters (Legal) Limited. UK Statutory Instruments Crown Copyright. Reproduced by permission of the Controller of Her Majesty's Stationery Office. 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 19991 as 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/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications3 to 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: Notes 1 Section 60 was amended by section 26(9) of the National Health Service Reform and Health Care Professions Act 2002 (c.17) (“the 2002 Act”), by paragraph 1 of Schedule 8, paragraph 10 of Schedule 10 and Part 2 of Schedule 15 to the Health and Social Care Act 2008 (c.14) (“the 2008 Act”) and by S.I.2002/253 and 254. Subsection (4) of section 62 of the Act was substituted by subsections (4) and (4A) as inserted by paragraph 11 of Schedule 10 to the 2008 Act. Schedule 3 has been amended as follows: by section 26(10) of the 2002 Act; by paragraph 67 of Schedule 11, and Part 4 of Schedule 14, to the Health and Social Care (Community Health and Standards) Act 2003 (c.43); by Schedule 9 to the Health Act 2006 (c.28); by paragraphs 3 to 10 of Schedule 8, paragraph 12 of Schedule 10 and Part 2 of Schedule 15, to the 2008 Act; and by S.I.2002/254. SI 2010/231 Page 2 2 Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c.51) and amended by S.I.2007/1388. 3 OJ No. L255, 30.09.2005, p22, as amended by Council Directive 2006/100/EEC of 20 November 2006, OJ No. L363 of 20.12.2006, p141. Extent Preamble: England, Wales, Scotland PART 1 Preliminary Law In Force 1.— Citation and commencement (1) This Order may be cited as the Pharmacy Order 2010. (2) The following provisions come into force on the day after the day on which this Order is made— (a) this article; (b) articles 2, 3, 4(1), (2), (3)(b), (5) and (8) and 7 and Schedule 1; and (c) articles 65, 66, 69(1) to (4) and 70 and Schedules 5 and 6. (3) Except as provided for by paragraph (2), the provisions of this Order which confer powers enabling rules or orders to be made, or which enable standards or requirements to be set by the Council, come into force on the making of this Order, but for the purpose only of the exercise of those powers. (4) Rules under article 7(1) and (4) are not to come into force before the end of the period of two years beginning with the day on which this Order is made. (5) Except as provided for by paragraphs (2) and (3), this Order comes into force on such day as the Privy Council may by order appoint. (6) Different days may be appointed by an order under paragraph (5) for different provisions or different purposes. Commencement Pt 1 art. 1(1)-(6): February 11, 2010 Extent Pt 1 art. 1(1)-(6): England, Wales, Scotland SI 2010/231 Page 3 Law In Force 2.— Extent (1) Subject to paragraph (2), this Order extends to England and Wales and Scotland. (2) The extent of any amendment, revocation, repeal or saving of any enactment set out in Schedules 4 and 6 is the same as that of the enactment amended, revoked, repealed or saved. Commencement Pt 1 art. 2(1)-(2): February 11, 2010 (SI 2010/231 Pt 1 art. 1(2)(b)) Extent Pt 1 art. 2(1)-(2): England, Wales, Scotland Law In Force 3.— Interpretation (1) In this Order— “the 2007 Order” means the Pharmacists and Pharmacy Technicians Order 20071 ; “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 1971 (controlled drugs and their classification); “the Council” means the General Pharmaceutical Council established by article 4; “the Directive” means Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications2 , 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 2000 (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; 4 [ […] “Directive 2002/58/EC” means Directive 2002/58/EC of the European Parliament and of the Council of 12th July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic 3 communications), as amended from time to time; ] “European mutual recognition area” means the territory of the EEA States5 and Switzerland; SI 2010/231 Page 4 6 [ “European professional card” has the meaning given in the Directive; ] “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 [ EU ] 7 right; or (c) a person who is not a national of a relevant European State but who is, by virtue of an enforceable [ EU ] 7 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 Union (Recognition of Professional 8 Qualifications) Regulations 2015 ] [ “IMI” means the Internal Market Information System, the online, secure messaging system developed by the European Commission; “IMI file” means a secure personal account in the IMI that is created in relation to an applicant for a European professional card by means of an online tool provided by the 3 European Commission; ] “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 20029 ; “medicinal product” has the same meaning as it has in the Medicines Act 1968 by virtue of section 130 of that Act10 (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 196811 (general sale lists); [ “the necessary knowledge of English” — (a) 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; (b) 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; 12 ] “the Pharmacy Acts” means the Pharmacy Act 185213 , the Pharmacy Act 186814 , the Pharmacy Act 190814 , the Pharmacy and Poisons Act 193315 and the Pharmacy Act 195416 ; 17 […] “prescribed” means prescribed by rules made by the Council; [ “professional traineeship” means a period of professional practice, carried out under supervision, that— (a) constitutes a condition for access to the profession of pharmacist or pharmacy technician in the country in which it is carried out; and (b) takes place during or after completion of a course of education leading to an educational qualification pursued for the purpose of entry to that profession; 6 ] SI 2010/231 Page 5 “the Register” means the register established