# The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021, Regulation 18: Amendment of regulation 201 (submission and evaluation of final study reports for required studies)


(1) Regulation 201 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).

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/18 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-18
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.