NIMAR supply to Northern Ireland167A

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.

List of NIMAR products167B

1

The licensing authority must maintain a list for the purposes of regulation 167A(4).

2

In relation to each listed NIMAR product, the list must specify the date the NIMAR product was added to the list.

3

The licensing authority must publish the list and keep it up to date.

4

A product may only be included on the list if the following conditions are satisfied—

a

Condition A is that the Secretary of State has in relation to Northern Ireland been provided with at least one of the following—

i

information requested under regulation 28 (provision of information about availability of health service medicines) of the 2018 Regulations;

ii

information under regulation 29 (requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines) of the 2018 Regulations;

b

Condition B is that the holder of a UK marketing authorisation, has notified the Secretary of State that—

i

in relation to a medicinal product to which a UKMA(UK) relates, the qualified person who is at the disposal of the holder of a manufacturer’s licence is unable to secure the matters mentioned in paragraph 12A of Schedule 7 for the purpose of supplying the product into Northern Ireland from Great Britain; or

ii

in relation to a medicinal product to which a UKMA(GB) relates, the inability of a qualified person who is at the disposal of the holder of a manufacturer’s licence to secure the matters mentioned in paragraph 12A of Schedule 7 prevents the holder of the UKMA(GB) from converting it into a UKMA(UK);

c

Condition C is that the licensing authority considers that clinical needs in Northern Ireland for the product may be unmet.

5

The licensing authority must remove a product from the list if the licensing authority considers that medicinal products, not including listed NIMAR products, available in Northern Ireland are capable of meeting clinical need.