The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

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

PART 4 Amendment of Part 5 (amendment of Part 5 (marketing authorisations))

79.  After regulation 101 (amendment of regulation 108 (application for renewal of certificate)) insert—

“Amendment of regulation 109 (failure to place on the market etc.)

101A.— (1) Regulation 109 (failure to place on the market etc.) is amended as follows.

(2) In paragraph (1) after “in the United Kingdom” insert “(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)”.

(3) In paragraph (2) after “in the United Kingdom” insert “(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)”.”.