C1PART 12Dealings with medicinal products

Annotations:
Modifications etc. (not altering text)

CHAPTER 3Exemptions

Exemptions relating to supply in specific circumstances

Exemption for supply by national health service bodies F1and local authorities229

1

Regulations 214(1) F12and (2), 220 and 221 do not apply to the supply of a medicinal product in accordance with condition A or B by—

a

the Common Services Agency;

b

a health authority or special health authority;

c

an NHS trust;

d

an NHS foundation trust;

F2da

a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); F6...

F7db

Public Health England;

dc

Public Health Agency; or

F3e

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

f

a person who is not a doctor, dentist or person lawfully conducting a retail pharmacy business, where the person supplies the product pursuant to an arrangement with F4F17an integrated care board, F18NHS England or one of the persons specified in paragraphs (a) F5to F8(dc).

2

Condition A is that the product is supplied for the purpose of being administered to a person in accordance with the written directions of a doctor, dentist, nurse independent prescriber, optometrist independent prescriber F9, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriberF10, paramedic independent prescriber or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

F112A

In relation to a medicinal product that is for parenteral administration, condition A only applies if the person who has given the written directions is an appropriate practitioner in relation to that medicinal product.

3

Condition B is that—

a

the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”);

b

the PGD relates to the supply of a description or class of medicinal product by the person by whom the medicinal product is supplied and has effect at the time at which it is supplied;

c

the PGD contains the particulars specified in Part 1 of Schedule 16;

d

the PGD is signed on behalf of the person specified in column 2 of the table in Part 2 of that Schedule (“the authorising person”) against the entry in column 1 of that table for the class of person by whom the product is supplied;

e

the individual who supplies the product—

i

belongs to one of the classes of individual specified in Part 4 of that Schedule, and

ii

is designated in writing, on behalf of the authorising person, for the purpose of the supply or administration of products under the PGD; and

F13f

when the product is supplied F14, either an authorisation by the licensing authority on a temporary basis under regulation 174 or—

i

in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), F15or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB), or

ii

in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.

F164

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