Regulation 167A NIMAR supply to Northern IrelandF1

(1)

If the following conditions are met—

(a)

the prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product sold or supplied, or offered for sale or supply, in Northern Ireland, and

(b)

that product is classified in Northern Ireland as a prescription only medicine.

(2)

Condition A is that a UK marketing authorisation of a following type is in force for the product—

(a)

a UKMA(UK);

(b)

a UKMA(GB).

(3)

Condition B is that the product is classified as a prescription only medicine in accordance with regulation 5(3) for the purposes of sale and supply in Great Britain.

(4)

Condition C is that the product is a listed NIMAR product.

(5)

Condition D is that if the product is to be distributed by wholesale dealing by a person (“P”) in Northern Ireland, P must be a holder of a wholesale dealer’s licence.

(6)

Condition E is that if the product is manufactured or assembled in Great Britain, it is supplied to Northern Ireland—

(a)

by the holder of a manufacturer’s licence in respect of that product; or

(b)

by the holder of a wholesale dealer’s licence.

(7)

Condition F is that if the product is manufactured outside of the UK and imported into Great Britain, it is supplied to Northern Ireland—

(a)

by a holder of a manufacturer’s licence in respect of that product; or

(b)

by the holder of a wholesale dealer’s licence.

Annotations

Textual amendments

F1: Regs. 167A, 167B inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 14