Paragraph 4 Pharmacovigilance in respect of old rules clinical trialsF1

(1)

Part 5 of the new rules applies in respect of old rules clinical trials as it does in respect of new rules clinical trials, subject to the following sub-paragraphs.

(2)

The sponsor of an old rules clinical trial may elect that Part 5 of the old rules is to apply, temporarily, in respect of the clinical trial, rather than Part 5 of the new rules, provided that the licensing authority has received notification of that election—

(a)

unless paragraph (b) applies, within the period of 60 days beginning with the day after the relevant day;

(b)

where, in order to comply with the old rules, a reporting or notification obligation under the old rules needs to be discharged before that 60 day period expires, when or before that reporting or notification obligation is discharged (which must be on or before the latest day on which that reporting notification needs to be discharged in order to comply with the old rules).

(3)

Where a sponsor of an old rules clinical trial has made a valid election pursuant to sub-paragraph (2), once the sponsor has discharged their obligations under regulation 35(1) of the old rules, or the period during which the sponsor is required to do so has expired, whichever is the sooner, the election ceases to have effect.

Annotations

Textual amendments

F1: Sch. 14 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 45