PART 3Amendment of Part 4 (amendment of Part 4 (requirement for authorisation))
33. In regulation 45 (amendment of regulation 46 (requirement for authorisation))—
(a)for paragraph (2)(b) and (c) substitute—
“(b)after sub-paragraph (a) insert—
“(aa)an EU marketing authorisation;”.”;
(b)for paragraphs (4)(a) to (c) substitute—
“(a)after “in force for the product” insert “in the country in which the product is intended to be sold or supplied, or offered for sale or supply”;
(b)in sub-paragraph (a), before “marketing authorisation”, insert “UK”; and
(c)after sub-paragraph (a) insert—
“(aa)an EU marketing authorisation;”.”;
(c)omit paragraph (5).
34. In regulation 46 (amendment of regulation 47 (breach of requirement)), omit paragraph (3).