Exemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agencies12D

1

The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine in the course of the business of—

a

in England, Wales or Scotland—

i

an independent hospital,

ii

an independent clinic, or

iii

an independent medical agency; or

b

in Northern Ireland, a nursing home,

where the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (2) are satisfied.

2

The conditions referred to are that—

a

the Patient Group Direction relates to the supply or, as the case may be, the administration, by the person who supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

b

the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

c

the Patient Group Direction is signed—

i

by or on behalf of the registered provider, and

ii

if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager;

d

the individual who supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing—

i

by or on behalf of the registered provider, or

ii

if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager,

for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and

e

at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forces12E

1

The restrictions imposed by section 58(2) (sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by an individual belonging to one of the classes specified in Part III of Schedule 7 to this Order where—

a

the individual supplies or, as the case may be, administers the medicine in order to assist the provision of health care by, on behalf of, or under arrangements made by—

i

a police force in England, Wales or Scotland,

ii

the Police Service of Northern Ireland,

iii

a prison service, or

iv

Her Majesty’s Forces;

b

the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, in accordance with a Patient Group Direction; and

c

the conditions specified in paragraph (2) are satisfied.

2

The conditions referred to are that—

a

the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine in order to assist the provision of health care by, or on behalf of, or under arrangements made by the police force or service, the prison service or, as the case may be, Her Majesty’s Forces;

b

the Patient Group Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

c

the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

d

the Patient Group Direction is signed—

i

by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the police force or service, the prison service or Her Majesty’s Forces by whom, or on whose behalf, the health care is provided, or with whom arrangements are made for the provision of such care; and

ii

in the case of a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland;

e

the individual referred to in paragraph (1) is designated in writing, by or on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and

f

at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.