Regulation 152 Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements)
(1)
Regulation 192 is amended as follows.
(2)
In paragraph (1)(a), insert “UK” before “marketing authorisation”.
(3)
In paragraph (3), for “EMA” substitute “licensing authority”.
(4)
Omit paragraphs (9) to (11).