Regulation 4 Amendment of regulation 19I1

In regulation 19 M1 (exemptions from requirement for wholesale dealer's licence), after paragraph (4) insert—

“(4A)

Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be used for vaccination or immunisation against coronavirus or influenza virus, where the person distributing the medicinal product—

(a)

was supplied with the medicinal product for the purposes of the administration of it under relevant arrangements;

(b)

is supplying the medicinal product for the purposes of the administration of it by the person to whom it is being supplied (or by a person employed or engaged by them) under relevant arrangements; and

(c)

is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements.

(4B)

Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be supplied or administered in accordance with a protocol of the type mentioned in regulation 247, where the person distributing the medicinal product—

(a)

was supplied with the medicinal product for the purposes of the supply or administration of it to a patient under relevant arrangements;

(b)

is supplying the medicinal product for the purposes of the supply or administration of it to a patient by the person to whom it is being supplied (or by a person employed or engaged by them) under relevant arrangements; and

(c)

is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements.

(4C)

In this regulation, “relevant arrangements” means—

(a)

arrangements for the provision of services as part of—

(i)

in England, the health service as defined by section 275(1) of the National Health Service Act 2006 M2,

(ii)

in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978 M3,

(iii)

in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006 M4, and

(iv)

in Northern Ireland, the system of health and social care promoted under section 2(1) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 M5; or

(b)

arrangements for the provision of services (otherwise than as mentioned in sub-paragraph (a)) as part of the medical services of Her Majesty's Forces.

(4D)

Paragraphs (4A) to (4C) cease to have effect on 1st April 2022.”.