SCHEDULES

SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 1Amendment of Part 2 (amendment of Part 1 (General))

I15

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 ”.