Regulation 16 Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report)I1

for “an EEA State” substitute “ a country ”; and

for sub-paragraphs (a) and (b), substitute—

“(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.”.