Regulation 167B List of NIMAR productsF1
The licensing authority must maintain a list for the purposes of regulation 167A(4).
In relation to each listed NIMAR product, the list must specify the date the NIMAR product was added to the list.
The licensing authority must publish the list and keep it up to date.
A product may only be included on the list if the following conditions are satisfied—
Condition A is that the Secretary of State has in relation to Northern Ireland been provided with at least one of the following—
information requested under regulation 28 (provision of information about availability of health service medicines) of the 2018 Regulations;
information under regulation 29 (requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines) of the 2018 Regulations;
Condition B is that the holder of a UK marketing authorisation, has notified the Secretary of State that—
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
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);
Condition C is that the licensing authority considers that clinical needs in Northern Ireland for the product may be unmet.
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.
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