|
| |
|
(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, |
| 5 |
(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 |
| |
| 10 |
(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 |
| |
| 15 |
(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.” |
| 20 |
(2) | In section 78 of the Medicines Act 1968 (c. 67) (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”. |
| 25 |
26 | Control of pharmacy premises: bodies corporate |
| |
(1) | For section 71 of the Medicines Act 1968 (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— |
| 30 |
(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 |
| 35 |
| |
(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. |
| 40 |
(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 |
| 45 |
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 |
| |
| |
(a) | the name of the responsible pharmacist for the time being, |
| 5 |
(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 |
| |
| 10 |
(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 |
| |
superintendent and who is a pharmacist. |
| 15 |
(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. |
| 20 |
(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 |
| |
the body corporate, specifying his name and stating whether he |
| 25 |
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), |
| 30 |
in subsection (2)(b), for “subsection (1)(a)” substitute “subsection (4)(b)”. |
| |
27 | Control of pharmacy premises: representative of pharmacist in case of death |
| |
| |
In section 72 of the Medicines Act 1968 (representative of pharmacist in case of |
| |
death or disability), for subsection (2) substitute— |
| 35 |
“(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 |
| |
of the pharmacist whose representative he is, have been notified |
| |
| |
(b) | that subsections (2A) and (2B) of this section are both satisfied |
| 40 |
as respects each of the premises at which the business is carried |
| |
on and medicinal products, other than medicinal products on a |
| |
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 |
| 45 |
section, 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. |
| |
(2B) | This subsection is satisfied if a notice is conspicuously displayed at |
| 5 |
| |
(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 |
| |
| 10 |
(c) | the fact that he is for the time being in charge of the business at |
| |
| |
28 | The responsible pharmacist |
| |
(1) | After section 72 of the Medicines Act 1968 (c. 67) insert— |
| |
“72A | The responsible pharmacist |
| 15 |
(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 |
| 20 |
(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. |
| 25 |
(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 |
| 30 |
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 |
| |
| 35 |
(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 |
| 40 |
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 |
| |
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, |
| 5 |
(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 |
| 10 |
| |
(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 |
| 15 |
by regulations under subsection (7)(a) is not to be considered as a |
| |
responsible pharmacist for the purposes of sections 70 to 72 of this Act. |
| |
(9) | Subsection (10) applies if a person— |
| |
(a) | fails to comply with the requirements of subsection (2) or |
| |
regulations made under it, |
| 20 |
(b) | fails to comply with any requirements as to absence from the |
| |
premises contained in regulations under subsection (7)(b). |
| |
(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 |
| |
premises in question (or in a subsection (9)(a) case at any of them) for |
| 25 |
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 |
| 30 |
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— |
| 35 |
(a) | subsection (4) of section 72A of this Act (which requires the |
| |
responsible pharmacist to make entries in the record), |
| |
(b) | subsection (5) of that section (which requires the keeping and |
| |
preservation of a record relating to the responsible |
| |
| 40 |
(4) | In section 108 of the Medicines Act 1968 (enforcement in England and Wales), |
| |
| |
(a) | after paragraph (a) insert— |
| |
“(aa) | the provisions of subsections (4) and (5) of section 72A |
| |
| 45 |
(b) | after “paragraphs (a)” insert “, (aa)”. |
| |
|
| |
|
| |
|
(5) | In section 110 of the Medicines Act 1968 (c. 67) (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 |
| |
| 5 |
(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), |
| 10 |
omit paragraph 2(2) (which imposes a limitation on amendment of the |
| |
| |
| |
The National Health Service |
| |
| 15 |
| |
| |
(1) | After section 42 of the 1977 Act insert— |
| |
“42A | Power to charge: England |
| |
(1) | The Secretary of State may give directions to a Primary Care Trust |
| 20 |
requiring it to charge a fee in cases or descriptions of case specified in |
| |
the directions to persons who make an application referred to in section |
| |
42(2)(c)(i) or (ii) to the Primary Care Trust. |
| |
(2) | The Secretary of State may in the directions— |
| |
(a) | specify the fee himself, or |
| 25 |
(b) | require the Primary Care Trust to determine the amount of the |
| |
fee in accordance with any requirements set out in the |
| |
| |
(3) | Before determining the amount of the fee- |
| |
(a) | in a subsection (2)(a) case, the Secretary of State must consult |
| 30 |
such organisations as he thinks fit that appear to him to |
| |
represent persons providing pharmaceutical services and such |
| |
organisations as he thinks fit that appear to him to represent |
| |
| |
(b) | in a subsection (2)(b) case, the Primary Care Trust must |
| 35 |
undertake any consultation required by the directions. |
| |
(4) | The Secretary of State must publish in such manner as he thinks fit any |
| |
directions he gives under this section. |
| |
(5) | In a subsection (2)(b) case, the Primary Care Trust must publish in such |
| |
manner as it thinks fit the fee which it determines. |
| 40 |
|
| |
|