Paragraph 59 Matters on-going at IP completion day in respect of periodic safety update reportsF1

a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive;

the procedure described in Article 107e(3) of the 2001 Directive has been completed before IP completion day; but

the licensing authority has not yet taken the steps described in regulation 194 before IP completion day.

a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive; and

the procedure described in Article 107e(3) of the 2001 Directive has not been completed before IP completion day.

may notify a holder falling within sub-paragraph (3)(a) of the need to provide to it such further information that the licensing authority specifies; and

must, subject to sub-paragraph (5), assess the periodic safety update report in accordance with regulation 195 (obligations on licensing authority to assess PSURs) (as amended by the EU Exit Regulations) as soon as reasonably practicable.

any relevant information obtained by it before IP completion day in relation to the periodic safety report and the assessment of that report as a consequence of its involvement in any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

any relevant decision made, or agreement reached, in relation to the periodic safety update report or its assessment before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

any decision made, or agreement reached, in relation to that marketing authorisation or certificate of registration under Section 2 of Chapter III of the 2001 Directive on or after IP completion day, notwithstanding that the United Kingdom did not participate in the making of that decision or agreement.