S.L. 458.34 Art. 4ADerogation for products from the United Kingdom.

(1) By way of derogation from regulation 4(2), until the

31st December 2024, in the absence of a marketing authorisation or of a pending application for a marketing authorisation, the

Licensing Authority may authorise for justified public health reasons the placing on the market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland:

Provided that the Licensing Authority may also maintain in force or, until the 31st December 2024, extend marketing authorisations that were granted pursuant to this sub-regulation before the 20th April 2022 which authorise the placing on the market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland:

Provided further that authorisations that are granted, extended or maintained in force pursuant to the provisions of this sub-regulation shall not be valid after the 31st December 2026.

(2) By way of derogation from regulation 5(1)(b), the Licensing Authority may grant marketing authorisations as referred to in regulation 4(2), to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

(3) Where the Licensing Authority grants or extends a marketing authorisation as referred to in sub-regulation (1), it shall ensure compliance with the requirements of this regulation.

(4) Before granting a marketing authorisation pursuant to sub-regulation (1), the Licensing Authority:

(a) shall notify the marketing authorisation holder in parts of the United Kingdom other than Northern Ireland of the proposal to grant a marketing authorisation or to extend a marketing authorisation under this regulation in respect of the medicinal product concerned;

(b) may request the competent authority in the United Kingdom to submit the relevant information regarding the marketing authorisation of the medicinal product concerned.