|
| |
|
(2) | No contravention by the Crown of any provision of this Chapter shall make the |
| |
Crown criminally liable; but the High Court (or, in Scotland, the Court of |
| |
Session) may declare unlawful any act or omission of the Crown which |
| |
constitutes such a contravention. |
| |
(3) | The provisions of this Chapter apply to persons in the public service of the |
| 5 |
Crown as they apply to other persons. |
| |
| |
(1) | This section applies to functions conferred on the relevant authority by this |
| |
| |
(2) | Subject to subsection (4), any functions to which this section applies are |
| 10 |
exercisable in relation to England by the Secretary of State. |
| |
(3) | Subject to subsection (4), any functions to which this section applies are |
| |
exercisable in relation to Wales by the National Assembly for Wales. |
| |
(4) | Any power of the relevant authority to make regulations under this Chapter is |
| |
exercisable in relation to cross-border bodies by the Secretary of State after |
| 15 |
consultation with the Assembly. |
| |
(5) | A “cross-border body” is a body which— |
| |
(a) | performs (and only performs) functions in respect of England and |
| |
| |
(b) | does not perform functions mainly in respect of England or mainly in |
| 20 |
| |
(6) | Any functions to which this section applies are exercisable in relation to |
| |
Scotland by the Secretary of State after consultation with the Scottish Ministers. |
| |
(7) | Any functions to which this section applies are exercisable in relation to |
| |
Northern Ireland by the Department of Health, Social Services and Public |
| 25 |
| |
| |
| |
“accountable officer” is to be read in accordance with section 16(2); |
| |
“body” includes an unincorporated association; |
| 30 |
“controlled drug” has the meaning given by section 2 of the Misuse of |
| |
| |
“designated body” has the meaning given by section 16(3); |
| |
| |
(a) | services provided to individuals for or in connection with the |
| 35 |
prevention, diagnosis or treatment of illness, and |
| |
(b) | the promotion and protection of public health; |
| |
“health care professional”— |
| |
(a) | in relation to England and Wales, has the meaning given by |
| |
section 28X(3)(a) of the National Health Service Act 1977 (c. 49) |
| 40 |
(referred to in this Act as “the 1977 Act”), |
| |
(b) | in relation to Scotland, has the meaning given by section 17D(2) |
| |
of the National Health Service (Scotland) Act 1978 (c. 29), and |
| |
|
| |
|
| |
|
(c) | in relation to Northern Ireland, has the meaning given by |
| |
Article 15C of the Health and Personal Social Services |
| |
(Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I. 14)); |
| |
| |
(a) | in relation to England and Wales, has the meaning given by |
| 5 |
section 128(1) of the 1977 Act, |
| |
(b) | in relation to Scotland, has the meaning given by section 108(1) |
| |
of the National Health Service (Scotland) Act 1978 (c. 29), and |
| |
(c) | in relation to Northern Ireland, has the meaning given by |
| |
Article 2(2) of the Health and Personal Social Services (Northern |
| 10 |
| |
“relevant authority” is to be read in accordance with section 22; |
| |
“relevant records” has the meaning given by section 18(8); |
| |
“responsible body” has the meaning given by section 17(2). |
| |
(2) | In this Chapter any reference to the management or use of controlled drugs |
| 15 |
| |
(a) | the storage, carriage and safe custody of such drugs, |
| |
(b) | the prescribing and supply of such drugs, |
| |
(c) | the administration of such drugs, |
| |
(d) | the recovery of such drugs when no longer needed, and |
| 20 |
(e) | the disposal of such drugs. |
| |
| |
| |
24 | Requirements about supervision |
| |
(1) | In section 10 of the Medicines Act 1968 (c. 67) (which provides for exemptions |
| 25 |
for pharmacists in relation to certain dealings with medicinal products), after |
| |
| |
“(7A) | The Health Ministers may make regulations prescribing conditions |
| |
which must be complied with if a thing is to be considered for the |
| |
purposes of this section as done under the supervision of a pharmacist. |
| 30 |
(7B) | Conditions prescribed under subsection (7A) may relate to supervision |
| |
in the case where the pharmacist is not at the place where the thing is |
| |
being done, and in that case the thing is not to be so considered if no |
| |
such conditions are prescribed. |
| |
(7C) | In any case, compliance with any applicable conditions is sufficient for |
| 35 |
the thing to be so considered.” |
| |
(2) | In section 52 of that Act (sale or supply of medicines not on general sale list)— |
| |
(a) | the existing text is to be subsection (1), |
| |
(b) | after that subsection insert— |
| |
“(2) | The Health Ministers may make regulations prescribing |
| 40 |
conditions which must be complied with if a transaction |
| |
mentioned in subsection (1)(c) is to be considered for the |
| |
purposes of this section as done under the supervision of a |
| |
| |
|
| |
|
| |
|
(3) | Conditions prescribed under subsection (2) may relate to |
| |
supervision in the case where the pharmacist is not on the |
| |
premises, and in that case the transaction is not to be so |
| |
considered if no such conditions are prescribed. |
| |
(4) | In any case, compliance with any applicable conditions is |
| 5 |
sufficient for the transaction to be so considered.” |
| |
25 | Control of pharmacy premises: individuals and partnerships |
| |
(1) | For section 70 of the Medicines Act 1968 (c. 67) (pharmacy business carried on |
| |
by individual pharmacist or by partners) substitute— |
| |
“70 | Business carried on by individual pharmacist or by partners |
| 10 |
(1) | The conditions referred to in section 69(1)(a) of this Act are that |
| |
subsections (2) and (3) of this section are both satisfied as respects each |
| |
of the premises where the retail pharmacy business is carried on and |
| |
medicinal products, other than medicinal products on a general sale |
| |
list, are sold by retail. |
| 15 |
(2) | This subsection is satisfied if a responsible pharmacist who satisfies the |
| |
requirements of subsections (4) and (5) of this section is in charge of the |
| |
business at those premises, 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 |
| 20 |
(b) | the supply at those premises of such products in circumstances |
| |
corresponding to retail sale. |
| |
(3) | This subsection is satisfied if a notice is conspicuously displayed at |
| |
| |
(a) | the name of the responsible pharmacist for the time being, |
| 25 |
(b) | the number of his registration under the Pharmacy Act 1954 or |
| |
(in relation to Northern Ireland) the Pharmacy (Northern |
| |
| |
(c) | the fact that he is for the time being in charge of the business at |
| |
| 30 |
(4) | The responsible pharmacist must be— |
| |
(a) | the person carrying on the business, or |
| |
(b) | if the business is carried on by a partnership, one of the partners |
| |
or, in Scotland, one of the partners who is a pharmacist, or |
| |
| 35 |
(5) | In relation to premises in Great Britain that have been registered |
| |
pharmacies for less than three years, the responsible pharmacist may |
| |
not be a person who is a pharmacist by virtue of section 4A of the |
| |
Pharmacy Act 1954 (qualification by European diploma) or any |
| |
corresponding provision applying to Northern Ireland.” |
| 40 |
(2) | In section 78 of the Medicines Act 1968 (restrictions on use of titles, descriptions |
| |
and emblems), in subsection (7), for the words from “under whose” to the end |
| |
substitute “who is in charge of the business at those premises (so far as |
| |
concerns the retail sale of medicinal products or the supply of such products in |
| |
circumstances corresponding to retail sale) is also a pharmacist”. |
| 45 |
|
| |
|
| |
|
26 | Control of pharmacy premises: bodies corporate |
| |
(1) | For section 71 of the Medicines Act 1968 (c. 67) (pharmacy business carried on |
| |
by body corporate) substitute— |
| |
“71 | Business carried on by body corporate |
| |
(1) | The conditions referred to in section 69(1)(b) of this Act are— |
| 5 |
(a) | that the retail pharmacy business, so far as concerns the |
| |
keeping, preparing and dispensing of medicinal products other |
| |
than medicinal products on a general sale list, is under the |
| |
management of a superintendent in respect of whom the |
| |
requirements specified in subsection (6) of this section are |
| 10 |
| |
(b) | that subsections (2) and (3) of this section are both satisfied as |
| |
respects each of the premises where the business is carried on |
| |
and medicinal products, other than medicinal products on a |
| |
general sale list, are sold by retail. |
| 15 |
(2) | This subsection is satisfied if a responsible pharmacist who satisfies the |
| |
requirements of subsections (4) and (5) of this section is in charge of the |
| |
business at the premises mentioned in subsection (1)(b) of this section, |
| |
| |
(a) | the retail sale at those premises of medicinal products (whether |
| 20 |
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. |
| |
(3) | This subsection is satisfied if a notice is conspicuously displayed at |
| |
| 25 |
(a) | the name of the responsible pharmacist for the time being, |
| |
(b) | the number of his registration under the Pharmacy Act 1954 or |
| |
(in relation to Northern Ireland) the Pharmacy (Northern |
| |
| |
(c) | the fact that he is for the time being in charge of the business at |
| 30 |
| |
(4) | The responsible pharmacist must be— |
| |
(a) | the superintendent mentioned in subsection (1)(a) of this |
| |
| |
(b) | a manager or assistant subject to the directions of the |
| 35 |
superintendent and who is a pharmacist. |
| |
(5) | In relation to premises in Great Britain that have been registered |
| |
pharmacies for less than three years, the responsible pharmacist may |
| |
not be a person who is a pharmacist by virtue of section 4A of the |
| |
Pharmacy Act 1954 (qualification by European diploma) or any |
| 40 |
corresponding provision applying to Northern Ireland. |
| |
(6) | The requirements referred to in subsection (1)(a) of this section in |
| |
relation to a superintendent are that— |
| |
| |
(b) | a statement in writing signed by him, and signed on behalf of |
| 45 |
the body corporate, specifying his name and stating whether he |
| |
is a member of the board of that body or not, has been sent to |
| |
| |
|
| |
|
| |
|
(c) | he does not act in a similar capacity for any other body |
| |
| |
(2) | In section 124 of the Medicines Act 1968 (c. 67) (offences by bodies corporate), |
| |
in subsection (2)(b), for “subsection (1)(a)” substitute “subsection (4)(b)”. |
| |
27 | Control of pharmacy premises: representative of pharmacist in case of death |
| 5 |
| |
In section 72 of the Medicines Act 1968 (representative of pharmacist in case of |
| |
death or disability), for subsection (2) substitute— |
| |
“(2) | The conditions referred to in section 69(1)(c) of this Act are— |
| |
(a) | that the name and address of the representative, and the name |
| 10 |
of the pharmacist whose representative he is, have been notified |
| |
| |
(b) | that subsections (2A) and (2B) of this section are both satisfied |
| |
as respects each of the premises at which the business is carried |
| |
on and medicinal products, other than medicinal products on a |
| 15 |
general sale list, are sold by retail. |
| |
(2A) | This subsection is satisfied if a responsible pharmacist is in charge of |
| |
the business at the premises mentioned in subsection (2)(b) of this |
| |
section, so far as concerns— |
| |
(a) | the retail sale at those premises of medicinal products (whether |
| 20 |
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. |
| |
(2B) | This subsection is satisfied if a notice is conspicuously displayed at |
| |
| 25 |
(a) | the name of the responsible pharmacist for the time being, |
| |
(b) | the number of his registration under the Pharmacy Act 1954 or |
| |
(in relation to Northern Ireland) the Pharmacy (Northern |
| |
| |
(c) | the fact that he is for the time being in charge of the business at |
| 30 |
| |
28 | The responsible pharmacist |
| |
(1) | After section 72 of the Medicines Act 1968 insert— |
| |
“72A | The responsible pharmacist |
| |
(1) | It is the duty of the responsible pharmacist mentioned in sections 70, 71 |
| 35 |
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 |
| 40 |
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. |
| 45 |
|
| |
|
| |
|
(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 |
| 5 |
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 |
| |
| 10 |
(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 |
| 15 |
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 |
| |
| |
(a) | the qualifications and experience which a person must have if |
| 20 |
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 |
| 25 |
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 |
| |
| 30 |
(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 |
| |
| |
(8) | A person who does not have the qualifications and experience required |
| |
by regulations made by virtue of subsection (7)(a) is not to be |
| 35 |
considered as a responsible pharmacist for the purposes of sections 70 |
| |
| |
(9) | Subsection (10) applies if a person— |
| |
(a) | fails to comply with the requirements of subsection (2) or |
| |
regulations made under it, |
| 40 |
(b) | fails to comply with any requirements as to absence from the |
| |
premises contained in regulations made by virtue of subsection |
| |
| |
(10) | 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 |
| 45 |
premises in question (or in a subsection (9)(a) case at any of them) for |
| |
the purposes of sections 70 to 72 of this Act. |
| |
|
| |
|
| |
|
(11) | In subsection (7)(c) and (d), “relevant activities” means things |
| |
mentioned in section 10 and transactions mentioned in section 52(1)(c) |
| |
| |
(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. |
| 5 |
(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 |
| 10 |
making of entries in a record relating to the responsible |
| |
| |
(b) | subsection (5) of that section (which requires the keeping and |
| |
preservation of the record).” |
| |
(4) | In section 108 of the Medicines Act 1968 (enforcement in England and Wales), |
| 15 |
| |
(a) | after paragraph (a) insert— |
| |
“(aa) | the provisions of subsections (4) and (5) of section 72A |
| |
| |
(b) | after “paragraphs (a)” insert “, (aa)”. |
| 20 |
(5) | In section 110 of the Medicines Act 1968 (enforcement in Northern Ireland), in |
| |
subsection (2), after “paragraphs (a)”, in both places, insert “, (aa)”. |
| |
| |
In section 129 of the Medicines Act 1968 (orders and regulations), in subsection |
| |
| 25 |
(a) | after “power to make” insert “an order or”, |
| |
(b) | after “making the” insert “order or”. |
| |
30 | Orders under s.60 of the Health Act 1999 |
| |
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), |
| 30 |
omit paragraph 2(2) (which imposes a limitation on amendment of the |
| |
| |
|
| |
|