SCHEDULES

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

PART 4 U.K. Amendment of Part 5 (amendment of Part 5 (marketing authorisations))

65.  For regulation 88 (omission of regulation 79 (failure to provide information on marketing authorisations to EMA)) substitute— U.K.

Amendment of regulation 79 (failure to provide information on marketing authorisations to EMA)

88.   In regulation 79 (failure to provide information on marketing authorisations to EMA)—

(a) in paragraph (1), for the first reference to “a marketing authorisation” substitute “ a UKMA(NI) or UKMA(UK) ”;

(b) in paragraph (2), for the first reference to “a marketing authorisation” substitute “ UKMA(NI) or UKMA(UK) ”.”.

Commencement Information

I1 Sch. 2 para. 65 in force at 31.12.2020 immediately before IP completion day, see reg. 1