25. Notifications of unexpected serious adverse drug reactions

Where any USADR occurs in a subject during a clinical trial which results in death or is life‑threatening, the sponsor must ensure that —

all relevant information about the USADR is —

recorded; and

reported to the Authority as soon as possible and in any event not later than 7 days after the sponsor first becomes aware of the event; and

any additional relevant information about the USADR is —

recorded; and

sent to the Authority within 8 days of making the record referred to in sub‑paragraph (i).

Where any USADR occurs in a subject during the clinical trial, other than a USADR referred to in paragraph (1), the sponsor must ensure that all relevant information about the reaction is —

recorded; and

reported to the Authority as soon as possible and in any event not later than 15 days after the sponsor first becomes aware of the event.

Upon a request made by the Authority, the sponsor must furnish to the Authority a report of —

the sponsor’s assessment of the risks associated with a USADR; and

the steps proposed to be taken —

to mitigate the risk; and

to inform the person whose consent is required for a person to be a subject or to continue to be a subject in the clinical trial, of the risk.

The sponsor must furnish the report referred to in paragraph (3) as soon as possible and in any event no later than 14 days after the Authority’s request.

Where any USADR occurs in a subject during a clinical trial which results in death or is life‑threatening, the sponsor must ensure that —

all relevant information about the USADR is —

recorded; and

reported to the Authority as soon as possible and in any event not later than 7 days after the sponsor first becomes aware of the event; and

any additional relevant information about the USADR is —

recorded; and

sent to the Authority within 8 days of making the record referred to in sub‑paragraph (i).

Where any USADR occurs in a subject during the clinical trial, other than a USADR referred to in paragraph (1), the sponsor must ensure that all relevant information about the reaction is —

recorded; and

reported to the Authority as soon as possible and in any event not later than 15 days after the sponsor first becomes aware of the event.

Upon a request made by the Authority, the sponsor must furnish to the Authority a report of —

the sponsor’s assessment of the risks associated with a USADR; and

the steps proposed to be taken —

to mitigate the risk; and

to inform the person whose consent is required for a person to be a subject or to continue to be a subject in the clinical trial, of the risk.

The sponsor must furnish the report referred to in paragraph (3) as soon as possible and in any event no later than 14 days after the Authority’s request.