Part 6Amendment to Part 5 (Pharmacovigilance)

Amendment to regulation 35

regulation 26 + 26.—(1) Regulation 35 (annual list of suspected serious adverse reactions and safety report) is amended as follows.

(2) In the heading, omit “list of suspected serious adverse reactions and”.

(3) For paragraph (1) substitute—

“(1) Within the period of 60 days beginning with the day after the day on which the reporting year ends, a sponsor shall, in relation to each investigational medicinal product tested in clinical trials referred to in regulation A32(1), provide the licensing authority with a report on the safety of the participants of those trials.”.

(4) After paragraph (1) insert—

“(1A) A report under paragraph (1) shall include—

(a)the records of, and evaluation relating to, any serious adverse reactions and serious adverse events which have occurred during the reporting year, including suspected unexpected serious adverse reactions, kept or conducted under regulation A32;

(b)the record of the taking of any measures referred to in regulation A32(2)(b);

(c)a description of how any safety concerns in the clinical trial have been assessed and managed; and

(d)a description of the overall safety profile of each investigational medicinal product being tested or used in the trials referred to in regulation A32(1), as well as a summary description of the processes adopted by the sponsor to monitor the overall safety profile of those products.

(1B) The records of serious adverse reactions and serious adverse events referred to in paragraph (1A)(a) may take the form of a list.

(1C) The licensing authority may request that the sponsor provide a list of serious adverse reactions and serious adverse events, including suspected unexpected serious adverse reactions, which have occurred at any time during the reporting year, in relation to a clinical trial referred to in regulation A32(1), where it considers it necessary to do so to investigate specific safety issues—

(a)which emerge from the report under paragraph (1); or

(b)which have otherwise come its attention, and raise concerns about the safety of the trial or the participants.

(1D) The sponsor shall provide the list requested under paragraph (1C) within the period of 30 days beginning with the day of receiving the request, or within such shorter period as the licensing authority may specify in the request.”.

(5) In paragraph (2), at the beginning, for “paragraph (1)” substitute “this regulation”.