Regulation 229 Exemption for supply by national health service bodies and local authoritiesF19

United Kingdom

(1)

Regulations 214(1) F1and (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;

F2(da)

a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); F3...

F4(db)

the United Kingdom Health Security Agency;

(dc)

Public Health Agency; or

F5(e)

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

(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 F6F7an integrated care board, F8NHS England or one of the persons specified in paragraphs (a) F9to F10(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 F11, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber F12, paramedic independent prescriber or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

F13(2A)

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

F14(f)

when the product is supplied F15, either an authorisation by the licensing authority on a temporary basis under regulation 174 or—

(i)

in Northern Ireland, a UKMA(NI), UKMA(UK)F16..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), F17or, 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.

F18(4)

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