SCHEDULES

SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 6Amendment of Part 7 (amendment of Part 7 (Traditional Herbal Registrations))

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In regulation 123 (amendment of regulation 140 (withdrawal of traditional herbal medicinal product from the market) for “140(1)(a)” to the end substitute “140(1) for sub-paragraph (a) substitute—

a

under—

i

regulation 135 or 136, in the case of a THR(GB);

ii

regulation 135 or 136 or Article 34(3) of the 2001 Directive, in the case of a THR(NI) or THR(UK),

the licensing authority revokes or suspends the registration; or