xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"

PART 5U.K.PHARMACOVIGILANCE

Notification of adverse eventsU.K.

32.—(1) An investigator shall report any serious adverse event which occurs in a subject at a trial site at which he is responsible for the conduct of a clinical trial immediately to the sponsor.

(2) An immediate report under paragraph (1) may be made orally or in writing.

(3) Following the immediate report of a serious adverse event, the investigator shall make a detailed written report on the event.

(4) Paragraphs (1) to (3) do not apply to serious adverse events specified in the protocol or the investigator’s brochure as not requiring immediate reporting.

(5) Adverse events, other than those to which paragraphs (1) to (3) apply, that are identified in the protocol as critical to evaluations of the safety of the trial shall be reported to the sponsor in accordance with the reporting requirements, including the time periods for such reporting, specified in that protocol.

(6) The reports made under paragraphs (1), (3) and (5) shall identify each subject referred to in the report by a number assigned to that subject in accordance with the protocol for the trial.

(7) The number assigned to a subject in accordance with the protocol must be different from the number of any other subject in that trial, including any subject at a trial site outside the United Kingdom.

(8) Where the event reported under paragraph (1) or (5) consists of, or results in, the death of a subject, the investigator shall supply—

(a)the sponsor; and

(b)in any case where the death has been reported to the relevant ethics committee, that committee,

with any additional information requested by the sponsor or, as the case may be, the committee.

(9) The sponsor shall keep detailed records of all adverse events relating to a clinical trial which are reported to him by the investigators for that trial.

(10) The licensing authority may, by sending a notice in writing to the sponsor, require him to send the records referred to in paragraph (9), or copies of such records, to the authority.

Notification of suspected unexpected serious adverse reactionsU.K.

33.—(1) A sponsor shall ensure that all relevant information about a suspected unexpected serious adverse reaction which occurs during the course of a clinical trial in the United Kingdom and is fatal or life-threatening is—

(a)recorded; and

(b)reported as soon as possible to—

(i)the licensing authority,

F1(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)the relevant ethics committee,

and in any event not later that 7 days after the sponsor was first aware of the reaction.

(2) A sponsor shall ensure that within 8 days of a report in accordance with paragraph (1)(b), any additional relevant information is sent to the persons or bodies listed in that paragraph.

(3) A sponsor shall ensure that a suspected unexpected serious adverse reaction which occurs during the course of a clinical trial in the United Kingdom, other than those referred to in paragraph (1), is reported as soon as possible to—

(a)the licensing authority;

F2(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)the relevant ethics committee,

and in any event not later that 15 days after the sponsor is first aware of the reaction.

F3(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) A sponsor shall ensure that, in relation to each clinical trial in the United Kingdom for which he is the sponsor, the investigators responsible for the conduct of a trial are informed of any suspected unexpected serious adverse reaction which occurs in relation to an investigational medicinal product used in that trial, whether that reaction occurs during the course of that trial or another trial for which the sponsor is responsible.

(6) The licensing authority shall—

(a)keep a record of all suspected unexpected serious adverse reactions relating to an investigational medicinal product which are brought to its attention, whether pursuant to paragraphs (1) or (3) or otherwise; and

F4(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Clinical trials conducted in [F5countries other than the United Kingdom] U.K.

34.  If a clinical trial is being conducted at a trial site in [F6another country] in addition to sites in the United Kingdom, the sponsor of that trial shall ensure that all suspected unexpected serious adverse reactions occurring at that site are [F7reported as soon as possible to the licensing authority, and in any event—

(a)in the case of a reaction that is fatal or life-threatening, within 7 days beginning with the day after the sponsor was first aware of the reaction; or

(b)in any other case, within 15 days beginning with the day after the sponsor is first aware of the reaction.]

Textual Amendments

Annual list of suspected serious adverse reactions and safety reportU.K.

35.—(1) As soon as practicable after the end of the reporting year, a sponsor shall, in relation to each investigational medicinal product tested in clinical trials in the United Kingdom for which he is the sponsor furnish the licensing authority and the relevant ethics committees with—

(a)a list of all the suspected serious adverse reactions which have occurred during that year in relation to—

(i)those trials, whether at trial sites in the United Kingdom or elsewhere, or

(ii)any other trials relating to that product which are conducted outside the United Kingdom and for which he is the sponsor,

including those reactions relating to any investigational medicinal product used as a placebo or as a reference in those trials; and

(b)a report on the safety of the subjects of those trials.

(2) In paragraph (1), “reporting year”, in relation to an investigational medicinal product, means the year ending on the anniversary of—

(a)in the case of a product which has a marketing authorization, the earliest date on which any such authorization relating to that product was granted or issued; or

(b)in any other case, the earliest date on which any clinical trial—

(i)relating to that product, and

(ii)for which the person responsible for making the report was the sponsor,

was authorised in an [F8any country].

(3) For the purposes of paragraph (2)(b), the date on which a clinical trial was authorised in [F9a country] is—

[F10(a)the date on which the trial was authorised by a regulatory body responsible for authorising clinical trials in that country; or

(b)where the clinical trial was conducted in a country without a formal authorisation process, a date designated by the sponsor that is linked to the commencement of the first clinical trial.]

Textual Amendments