PART 5Amendment of Part 5 (marketing authorisations)

Amendment of regulation 80 (urgent safety restrictions)89.

(1)

Regulation 80 is amended as follows.

(2)

In the introductory words, insert “UK” before “marketing authorisation”.

(3)

In sub-paragraph (a) for “or the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008”substitute “in accordance with paragraph 14(1) of Schedule 10A”.

(4)

In sub-paragraph (b) from “or the European Commission” to the end substitute “in accordance with paragraph 14(3) of Schedule 10A; or”.

(5)

For sub-paragraph (c) substitute—

“(c)

fails to submit an application for variation of the UK marketing authorisation to the licensing authority in accordance with paragraph 14(4) of Schedule 10A before the end of the period of fifteen days beginning with the day after—

(i)

the taking under paragraph 14(1) of Schedule 10A or, as the case may be,

(ii)

the imposition under paragraph 14(3) of that Schedule,

of an urgent safety restriction.”.