Regulation 16 Amendment of regulation 199 (submission of draft study protocols for required studies)

Regulation 199^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 to be 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)”.