Regulation 4 Applications for a regulatory decision before IP completion day
Subject to paragraph (2), a person (“the applicant”) may make an application (“the application”) to the UK regulator under this regulation for a regulatory decision set out in a paragraph of Schedule 3 specified in the third column of Table 1 in Schedule 1.
An application may only be made—
before IP completion day; and
after an equivalence direction has been made that makes a determination set out in the paragraph of Schedule 1 to the 2019 Regulations specified in the final column of the same row of Table 1.
An application under paragraph (1) must—
be made in such manner as the UK regulator may direct;
be accompanied by such other information as that regulator may direct.
The UK regulator must confirm promptly receipt of the application to the applicant.
The UK regulator must determine, and inform the applicant, within a reasonable time whether the application is complete and meets requirements set out in accordance with paragraph (3).
If the UK regulator determines that the application is not complete and does not meet requirements set out in accordance with paragraph (3), that regulator may—
request that the applicant provide further information; and
set such a time period for the provision of further information requested under sub-paragraph (a) as the regulator considers appropriate.
The UK regulator may at any time request that the applicant provide further information relating to the application.
The applicant must notify the UK regulator promptly of any material changes affecting the application.
The applicant may withdraw the application by giving notice to the UK regulator at any time before the application is determined.