Regulation 18 Amendment of regulation 201 (submission and evaluation of final study reports for required studies)

(1)

Regulation 201^f1 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 was conducted in an EEA State, the Pharmacovigilance Risk Assessment Committee,”

(4)

Omit paragraph (3).

Annotations

f1: Regulation 201 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).