Regulation 51 Amendment of Schedule 8A (material to accompany an application for a parallel import licence)I1

in sub-paragraph (a), after “pharmacovigilance” insert “ who resides and operates in the United Kingdom ”;

omit sub-paragraph (b); and

in paragraph (e) at the end inset “or, if kept in electronic form, from which it can be accessed, which in either case, must be in the United Kingdom”.