# The Human Medicines Regulations 2012, Regulation 167A: NIMAR supply to Northern Ireland


(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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/167A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-167A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.