Regulation 17 Amendment of regulation 200 (amendment to study protocols for required studies)

Regulation 200^f1 is amended as follows.

For paragraph (2)(a), substitute—

“(a)

the licensing authority; and”

For paragraph (2)(b), substitute—

“(b)

where the authorisation is a UKMA(NI) or UKMA(UK) and the study is being conducted in an EEA State, the Pharmacovigilance Risk Assessment Committee,”

Omit paragraph (3).

In paragraph (4), for “paragraphs (2) and (3)(a)” substitute “paragraph (2)(a)”.

In paragraph (6), for “paragraphs (2) and (3)(b)” substitute “paragraph (2)(b)”.