PART 3Manufacture and distribution of medicinal products and active substances

CHAPTER 2Manufacturing and wholesale dealing

Grant etc of licences

Exemptions from requirement for wholesale dealer's licence19.

(1)

Regulation 18 does not apply to the sale or offer for sale of a medicinal product by way of wholesale dealing, or possession for the purpose of such sale or offer, where paragraph (2) applies and the person selling or offering the product for sale is—

F1(a)

the holder of—

(i)

in the case of a product for sale or supply in Great Britain F2(including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland), a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”) which relates to the product, or

(ii)

in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK) F3... or an Article 126a authorisation (an “authorisation”) which relates to the product,

including a holder of an authorisation who manufactured or assembled the product; or

(b)

a person who is not the holder of an authorisation in relation to the product but manufactured or assembled the product F4in the United Kingdom to the order of a person who is the holder of an authorisation relating to the product.

(2)

This paragraph applies if—

(a)

until the sale, the medicinal product has been kept on the premises of the person who manufactured or assembled the product (in this regulation referred to as “authorised premises”); and

(b)

those premises are premises authorised for use for manufacture or assembly by that person's manufacturer's licence.

(3)

For the purposes of this regulation, a medicinal product is regarded as having been kept on authorised premises at a time when—

(a)

it was being moved from one set of authorised premises to another, or from one part of authorised premises to another part; or

(b)

it was being moved from authorised premises by way of delivery to a purchaser.

(4)

Regulation 18 does not apply to a person who in connection with the importation of a medicinal product—

(a)

provides facilities solely for transporting the product; or

(b)

acting as an import agent, handles the product where the product is imported solely to the order of another person who intends to sell the product or offer it for sale by way of wholesale dealing or to distribute it in any other way.

F5(4A)

Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be used for F6vaccination against an infectious disease, where the person distributing the medicinal product F7(Person A)—

(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 F8(Person B); F9...

(c)

is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements; F10and

F11(d)

conditions A and B in paragraphs (4E) and (4F) are met.

F12(4B)

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

(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,

(ii)

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

(iii)

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

F13(4E)

Condition A is that supply between Person A and Person B is agreed with the body making the arrangements to supply the medicinal product and the distribution occurs in exceptional circumstances, which are such that Person A and Person B are satisfied, having made appropriate enquiries, that—

(a)

there is an urgent public health need for a patient to have administered to them the medicinal product on a particular occasion that the distribution would facilitate;

(b)

there is no other way that the patient could receive treatment with the medicinal product without undue delay; and

(c)

there is no suitable alternative medicinal product that the patient could receive treatment with without undue delay.

(4F)

Condition B is that the medicinal product remains in its manufacturer’s original outer packaging, and is stored and transported, in accordance with the terms of its marketing authorisation.

F14(5)

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

F15(6)

Regulation 18 does not apply to a person (“P”) who imports a medicinal product into Great Britain from an approved country for import for administration to P or to any other person who is a member of P’s household.