Medicines PART 1 General provisions Citation, commencement and interpretation 1 1 This Order may be cited as the Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022. 2 This Part comes into force on the twenty-eighth day after the day on which this Order is made. 3 Parts 2 and 3 come into force on such days as the Privy Council may by order appoint. 4 Different days may be appointed under paragraph (3) for different purposes. 5 In this Order, “ the 1968 Act ” means the Medicines Act 1968 . Extent 2 1 Subject to paragraphs (2) and (3), this Order extends to England, Wales, Scotland and Northern Ireland. 2 Article 10(1) extends to England, Wales and Scotland only. 3 Article 10(2) extends to Northern Ireland only. Transitional and saving provisions 3 1 In connection with the commencement of any provision of Part 2 or 3, the Privy Council may by order make such transitional or saving provisions as it considers appropriate. 2 The power to make an order under paragraph (1) may be exercised— a so as to make different provision— i for different areas, ii with respect to different cases or different classes of cases, and iii in respect of the same case or class of case for different purposes; b in relation to all cases to which the power extends or in relation to those cases subject to specified exceptions; and c so as to make any supplementary, incidental or consequential provisions which the Privy Council considers necessary or expedient. Privy Council procedures and legislative procedures 4 1 Any power vested in the Privy Council to make an order under this Part may be exercised by any two or more members of the Privy Council. 2 Any power of the Privy Council to make an order under this Part is exercisable by statutory instrument, and for the purposes of section 1 of the Statutory Instruments Act 1946 (definition of “Statutory Instrument”), any power of the Privy Council to make an order under this Part is to be taken to be conferred by an Act of Parliament. 3 An order made (wholly or partly) under article 3(1) is subject to annulment by resolution of either House of Parliament. 4 Before making an order under article 1(3) that commences an amendment of the 1968 Act as it applies in Northern Ireland, or article 10(2), the Privy Council must obtain the agreement of the Department of Health in Northern Ireland to the making of the order. 5 Any act of the Privy Council under this Part is sufficiently signified by an instrument signed by the Clerk of the Privy Council. 6 Where an order of the Privy Council under this Part is signified by an instrument purporting to be signed by the Clerk of the Privy Council, that is evidence and in Scotland sufficient evidence of— a the fact that the order was duly made; and b the order’s terms. PART 2 Amendment of the Medicines Act 1968 Amendment of section 67A of the 1968 Act 5 1 Section 67A of the 1968 Act (defence to offence of contravening section 63(a) or (b): product not sold or supplied) is amended as follows. 2 In subsection (2), for paragraph (a) substitute— a the adulteration took place— i at a registered pharmacy, or ii in the course of the provision of a relevant pharmacy service; . 3 In subsection (3), for paragraph (a) substitute— a the adulteration took place— i at a registered pharmacy, or ii in the course of the provision of a relevant pharmacy service; . Amendment of section 67B of the 1968 Act 6 1 Section 67B of the 1968 Act (defence to offence of contravening section 63(a) or (b): product sold or supplied) is amended as follows. 2 In subsection (2), for paragraph (a) substitute— a the adulteration took place— i at a registered pharmacy, or ii in the course of the provision of a relevant pharmacy service; . 3 In subsection (4), in paragraph (c), after “retail pharmacy business” insert “, or the relevant pharmacy service,” . 4 In subsection (6), in paragraph (b), after “retail pharmacy business” insert “, or the relevant pharmacy service,” . Amendment of section 67C of the 1968 Act 7 1 Section 67C of the 1968 Act (defence to offence of contravening section 64) is amended as follows. 2 In subsection (2), for paragraph (a) substitute— a the product was dispensed— i at or from a registered pharmacy, or ii in the course of the provision of a relevant pharmacy service; . 3 In subsection (4), in paragraph (c), after “retail pharmacy business” insert “, or the relevant pharmacy service,” . 4 In subsection (6), in paragraph (b), after “retail pharmacy business” insert “, or the relevant pharmacy service,” . Amendment of section 67D of the 1968 Act 8 In section 67D of the 1968 Act (defences under sections 67A, 67B and 67C: evidence etc) in subsection (4), after “pharmacy” insert “or a relevant pharmacy service” . New section 67F of the 1968 Act 9 1 After section 67E of the 1968 Act (sections 67A to 67D: interpretation) insert— Sections 67A to 67D: “relevant pharmacy service” 67F 1 For the purposes of sections 67A to 67D a pharmacy service is a relevant pharmacy service if conditions A and B are met in respect of it. 2 Condition A is met in respect of a pharmacy service if— a the service is provided in England by a person in the course of carrying on a regulated activity in respect of which the person is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 ; b the service is provided in Wales— i in the course of the business of a hospital, ii in a prison or youth detention accommodation within the meaning of sections 185 to 187 of the Social Services and Well-being (Wales) Act 2014 (anaw 4) (see section 188 of that Act ), iii in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act ), iv by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 2 of the Care Standards Act 2000 , or v by a person in the course of providing a regulated service in respect of which the person is registered under Chapter 2 of Part 1 of the Regulation and Inspection of Social Care (Wales) Act 2016 (anaw 2); c the service is provided in Scotland— i in the course of the business of a hospital, ii in a prison within the meaning of section 49C of the Criminal Law (Consolidation) (Scotland) Act 1995 (see subsection (7) of that section), iii in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act), iv by a person in the course of providing an independent health care service which is registered under section 10P of the National Health Service (Scotland) Act 1978 , or v by a person in the course of carrying on a care service which is registered under Chapter 3 of Part 5 of the Public Services Reform (Scotland) Act 2010 (asp 8) ; or d the service is provided in Northern Ireland— i in the course of the business of a hospital, ii in a prison or other institution for the treatment of offenders, including a place mentioned in section 2 of the Treatment of Offenders Act (Northern Ireland) 1968 (c. 29 (N.I.)) and a juvenile justice centre within the meaning of the Criminal Justice (Children) (Northern Ireland) Order 1998 ( S.I. 1998/1504 (N.I. 9) ) (see Article 51(1) of that Order), iii in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act), or iv by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 ( S.I. 2003/431 (N.I. 9) ). 3 Condition B is met in respect of a pharmacy service if it has a chief pharmacist. 4 A chief pharmacist, in relation to a pharmacy service, is a pharmacist who— a plays a significant role (irrespective of whether other individuals also do so) in— i the making of decisions about how the whole or a substantial part of the activities of the pharmacy service are to be managed or organised, or ii the actual managing or organising of the whole or a substantial part of those activities, b has the authority to make decisions that affect the running of the pharmacy service so far as concerns the sale or supply of medicinal products, and c is responsible for securing that the pharmacy service is carried on safely and effectively. 5 For the purposes of subsection (4)(c) a pharmacy service is carried on safely and effectively if it is carried on in ways that ensure its safe and effective running so far as concerns the sale or supply of medicinal products. . 2 In consequence of paragraph (1), in section 67E of the 1968 Act (interpretation of sections 67A to 67D), in the heading, for “interpretation” substitute ““adulteration” and “registrant”” . PART 3 Amendment of the Pharmacy Order 2010 and the Pharmacy (Northern Ireland) Order 1976 Standards of conduct, ethics and performance 10 1 In article 48 of the Pharmacy Order 2010 (standards of conduct and performance)— a in paragraph (1A), before sub-paragraph (a) insert— za chief pharmacists for the purposes of section 67F of the Medicines Act 1968 , ; and b in paragraph (1B), after “responsibilities of” insert “chief pharmacists,” . 2 In paragraph 1 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976 (standards of conduct and performance)— a in sub-paragraph (1A), before paragraph (a) insert— za chief pharmacists for the purposes of section 67F of the Medicines Act 1968, ; and b in sub-paragraph (1B), after “responsibilities of” insert “chief pharmacists,” . Richard Tilbrook Clerk of the Privy Council