Part 6Amendment to Part 5 (Pharmacovigilance)

Amendment to regulation 33

regulation 25 + 25.—(1) Regulation 33 (notification of suspected unexpected serious adverse reactions) is amended as follows.

(2) For paragraph (1)(1) substitute—

“(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 reported as soon as possible to the licensing authority, and in any event no later than 7 days after the sponsor was first aware of the reaction.”.

(3) In paragraph (2)—

regulation 25 3 a + (a)for “paragraph (1)(b)” substitute “paragraph (1)”;

regulation 25 3 b + (b)for “persons or bodies listed in that paragraph” substitute “licensing authority”.

(4) For paragraph (3)(2) substitute—

“(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 the licensing authority, and in any event no later than 15 days after the sponsor is first aware of the reaction.”.

(5) Before paragraph (5) insert—

“(4A) Paragraphs (1) to (3) do not apply to suspected unexpected serious adverse reactions specified in the protocol as not requiring immediate reporting.

(4B) The sponsor shall report suspected unexpected serious adverse reactions to which paragraph (4A) applies to the licensing authority in accordance with the reporting requirements, including the time periods for such reporting, that are specified in the protocol.”.

(6) Omit paragraph (5).