Paragraph 5 I1

For regulation 8 (amendment of Schedule 1 (further provisions for classification of medicinal products)) substitute—

“8

In Schedule 1—

(a)

in paragraph 1—

(i)

in sub-paragraph (b), insert “ UK ” before “marketing authorisation”;

(ii)

in sub-paragraphs (e)(i), (f)(i) and (g)(i), for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence ”; and

(b)

in paragraph 4, for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation, Article 126a authorisation, parallel import licence ”.”.