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.