Regulation 142 Amendment of regulation 182 (obligation on holder to operate a pharmacovigilance system)

Regulation 182^f1 is amended as follows.

In paragraph (2)(a), for “resides and operates in the EU” substitute “is ordinarily resident, and operates, in the United Kingdom”.

In paragraph (3), insert at the beginning “Without prejudice to the requirements set out in regulation 65C and Schedule 10A (variations to a UK marketing authorisation)”.

Omit paragraph (6).