9.—(1) Regulation 175 (offences relating to exceptions) is amended as follows.
(2) In paragraph (3)(a), after “required by regulation” insert “167G(1)(g)(ii) (EAMS medicinal products: pharmacovigilance) or”.
(3) In paragraph (3)(b), after “required by regulation” insert “167G(1)(g)(iii) or”.
(4) In paragraph (3)(c), after “regulation 170(3)” insert “or of any relevant changes as required by regulation 167G(1)(f)”.