The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021 No.

PART 2 Amendment of the Human Medicines Regulations 2012

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

16.—(1) Regulation 199(1) is amended as follows.

(2) For paragraph (2)(a), substitute—

“(a) the licensing authority; and”.

(3) 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,”.

(4) Omit paragraph (3).

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

(1)

Regulation 199 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).