Regulation 222 Amendment of regulation 331 (findings and reports of inspections)

(1)

Regulation 331 is amended as follows.

(2)

In paragraph (1)—

(a)

insert “UK” before “marketing authorisation”; and

(b)

omit sub-paragraph (c) (and “and” immediately preceding it).

(3)

In paragraph (4) for sub-paragraph (c) substitute—

“(c)
in the case of a holder of a UK marketing authorisation or traditional herbal registration, Part 11 (pharmacovigilance).”.