Regulation 11A Definition of notifiable trialF1

(1)

In these Regulations, “notifiable trial” means a trial—

(a)

where there are no significant safety concerns with any of the investigational medicinal products, as far as the sponsor is aware having made reasonable enquiries;

(b)

which meets either Condition A, Condition B or Condition C; and

(c)

which does not involve either—

(i)

participants who are—

(aa)

under the age of 18 years,

(bb)

pregnant, or

(cc)

breastfeeding, or

(ii)

an investigational medicinal product that is—

(aa)

an advanced therapy medicinal product, or

(bb)

used for the first time in humans.

(2)

Condition A is that the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is authorised for use in the United Kingdom and either—

(a)

the product is used in accordance with that authorisation; or

(b)

the use of the product in the trial is supported by established clinical practice.

(3)

Condition B is that a trial relating to the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, has been approved in the United Kingdom within the preceding 2 years of the date of request for approval whereby—

(a)

the product was investigated at—

(i)

the same or higher dose,

(ii)

the same or higher frequency, and

(iii)

the same or longer duration;

(b)

the same manufacturing process was utilised for the product; and

(c)

the approved trial—

(i)

utilised the same route of administration for the product, and

(ii)

investigated the product for the same indication.

(4)

Condition C is that the trial has undergone assessment, and been approved, by the appropriate authority responsible for the licensing of clinical trials in one or more of the following—

(a)

the European Union;

(b)

an EEA State;

(c)

the United States of America.

Annotations

Textual amendments

F1: Regs. 11A, 11B inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 11