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PART 3 continued CHAPTER 2 continued
(1) After section 72 of the Medicines Act 1968 (c. 67) insert—
(1) It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy business at the premises in question so far as concerns—
(a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and
(b) the supply at those premises of such products in circumstances corresponding to retail sale.
(2) A person may not be the responsible pharmacist in respect of more than one set of premises at the same time, except in circumstances specified by the Health Ministers in regulations, and then only if such conditions as may be so specified are complied with.
(3) The responsible pharmacist must establish (if they are not already established), maintain and keep under review procedures designed to secure the safe and effective running of the business as mentioned in subsection (1) of this section.
(4) The responsible pharmacist must make a record (which must be available at the premises) of—
(a) who the responsible pharmacist is in relation to the premises on any day and at any time, and
(b) such other matters as the Health Ministers specify in regulations.
(5) It is the duty of the person carrying on the business to secure that—
(a) the record is properly maintained, and
(b) it is preserved for at least as long as is specified in regulations made by the Health Ministers.
(6) The Health Ministers may make further provision in regulations in relation to the responsible pharmacist.
(7) The regulations may, in particular, make further provision about the matters mentioned in subsections (1) to (4) of this section, and make provision about—
(a) the qualifications and experience which a person must have if he is to be a responsible pharmacist,
(b) the responsible pharmacist’s absence from the premises,
(c) the supervision by the responsible pharmacist, when he is not present on the premises, of relevant activities there,
(d) circumstances in which the responsible pharmacist may supervise relevant activities at a pharmacy of which he is not the responsible pharmacist,
(e) the form in which the procedures referred to in subsection (3) of this section are to be recorded and matters which must be covered by them,
(f) the form in which the record referred to in subsection (4) of this section is to be kept and particulars which must be included in it.
(8) In subsection (7)(c) and (d), “relevant activities” means things mentioned in section 10 and transactions mentioned in section 52(1)(c) of this Act.
(1) The failure by a person to comply with any requirements of section 72A of this Act, or of regulations made under that section, may constitute misconduct for the purposes of section 80 of this Act, section 8 of the Pharmacy Act 1954 and Article 20 of the Pharmacy (Northern Ireland) Order 1976; and the Statutory Committee may deal with such a failure accordingly.
(2) A person who does not have the qualifications and experience required by regulations made by virtue of section 72A(7)(a) of this Act is not to be considered as a responsible pharmacist for the purposes of sections 70 to 72 of this Act.
(3) Subsection (4) of this section applies if a person—
(a) fails to comply with the requirements of subsection (2) of section 72A of this Act, or of regulations made under that subsection,
(b) fails to comply with any requirements as to absence from the premises contained in regulations made by virtue of subsection (7)(b) of that section.
(4) If this subsection applies, the person in question is not to be considered while the failure continues as being in charge of the business at the premises in question (or in a subsection (3)(a) case at any of them) for the purposes of sections 70 to 72 of this Act.”
(2) In section 77 of the Medicines Act 1968 (c. 67) (annual return of premises to registrar), omit paragraph (b) and the “and” immediately preceding it.
(3) In section 84 of the Medicines Act 1968 (offences), before subsection (1) insert—
“(A1) A person who fails to comply with either of the following shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 3 on the standard scale—
(a) subsection (4) of section 72A of this Act (which requires the making of entries in a record relating to the responsible pharmacist),
(b) subsection (5) of that section (which requires the keeping and preservation of the record).”
(1) In section 108 of the Medicines Act 1968 (c. 67) (enforcement in England and Wales)—
(a) in subsection (1), at the beginning insert “Subject to the provisions of subsection (6C) of this section,”,
(b) after subsection (6) insert—
“(6A) The Pharmaceutical Society shall be under a duty, concurrently with the appropriate Minister, to enforce the provisions of subsections (4) and (5) of section 72A of this Act in their application to England and Wales.
(6B) The Pharmaceutical Society shall be under a duty to enforce the other provisions of section 72A of this Act, and any regulations made under them, in their application to England and Wales.
(6C) The appropriate Minister shall be under no duty to enforce those other provisions, or any regulations made under them, in their application to England and Wales.
(6D) Notwithstanding subsection (6C) of this section the appropriate Minister is to be treated for the purposes of sections 111 to 114 of this Act—
(a) as empowered by this section to enforce those other provisions, or any regulations made under them, in their application to England and Wales, and
(b) to that extent as an enforcement authority in relation to those other provisions or those regulations in their application to England and Wales.”,
(c) in subsection (9)(a), after “hospital” insert “(except in relation to so much of the hospital premises as is a registered pharmacy)”,
(d) in subsection (10), for “(4) to (8)” substitute “(4) to (6A), (7) and (8)”.
(2) In section 109 of the Medicines Act 1968 (enforcement in Scotland), in subsection (1), at the beginning insert “Subject to the provisions of section 108(6C) of this Act as applied by subsection (2) of this section,”.
(3) In section 110 of the Medicines Act 1968 (enforcement in Northern Ireland)—
(a) in subsection (1), for “subsection (4)” substitute “subsections (3C) and (4)”,
(b) after subsection (3) insert—
“(3A) The Pharmaceutical Society shall be under a duty, concurrently with the Minister, to enforce the provisions of subsections (4) and (5) of section 72A of this Act in their application to Northern Ireland.
(3B) The Pharmaceutical Society shall be under a duty to enforce the other provisions of section 72A of this Act, and any regulations made under them, in their application to Northern Ireland.
(3C) The Minister shall be under no duty to enforce those other provisions, or any regulations made under them, in their application to Northern Ireland.
(3D) Notwithstanding subsection (3C) of this section the Minister is to be treated for the purposes of sections 111 to 114 of this Act—
(a) as empowered by this section to enforce those other provisions, or any regulations made under them, in their application to Northern Ireland, and
(b) to that extent as an enforcement authority in relation to those other provisions or those regulations in their application to Northern Ireland.”,
(c) in subsection (5)(a), for “and (3)” substitute “to (3D)”,
(d) in subsection (5)(b), for “(4) to (8)” substitute “(4) to (6A), (7) and (8)”.
In section 129 of the Medicines Act 1968 (c. 67) (orders and regulations), in subsection (5)—
(a) after “power to make” insert “an order or”,
(b) after “making the” insert “order or”.
In Schedule 3 to the Health Act 1999 (c. 8) (which makes further provision about orders under section 60 of that Act regulating health care professions), omit paragraph 2(2) (which imposes a limitation on amendment of the Medicines Act 1968).
Health Act 2006