PART 12Dealings with medicinal products
CHAPTER 3Exemptions
Exemptions relating to supply in specific circumstances
Exemption for supply etc of products under a PGD to assist the police etc234.
(1)
Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product by an individual belonging to one of the classes specified in Part 4 of Schedule 16 in accordance with the following conditions.
(2)
Condition A is that the individual supplies or (as the case may be) administers the product to assist the provision of health care by, on behalf of, or under arrangements made by, one of the following bodies (“the relevant body”)—
(a)
a police force in England and Wales or in Scotland;
(b)
the Police Service of Northern Ireland;
F1(c)
a prison service;
(d)
Her Majesty’s Forces; or
(e)
a contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency.
(3)
Condition B is that the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).
(4)
Condition C is that the PGD relates to the supply or (as the case may be) the administration of a description or class of medicinal product to assist the provision of health care by, on behalf of, or under arrangements made by, the relevant body.
(5)
Condition D is that the PGD has effect at the time at which the product is supplied or (as the case may be) administered.
(6)
Condition E is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).
(7)
Condition F is that the PGD is signed—
(a)
by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for the relevant body; and
(b)
where the relevant body is a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland.
(8)
Condition G is that the individual who supplies the product is designated in writing by or on behalf of the relevant body for the purpose of the supply or (as the case may be) the administration of medicinal products under the PGD.
F2(9)
Condition H is that when the product is supplied F3, either an authorisation by the licensing authority on a temporary basis under regulation 174 or—
(a)
(b)
in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),
is in force in relation to it.