Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report)I116
1
Regulation 35 is amended as follows.
2
In paragraph (2)(b), for “EEA State” substitute “
any country
”
.
3
In paragraph (3)—
a
for “an EEA State” substitute “
a country
”
; and
b
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.