The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 No. 775

PART 4 Amendment of Part 4 (requirement for authorisation)

Amendment of regulation 46 (requirement for authorisation)

45.—(1) Regulation 46 is amended as follows.

(2) In paragraph (2)—

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

(b) at the end of sub-paragraph (b), insert “or”; and

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

(3) In paragraph (3), before “European Economic Area” insert “United Kingdom or the”.

(4) In paragraph (6)—

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

(b) at the end of sub-paragraph (b), insert “or”; and

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

(5) In paragraph (7), omit sub-paragraph (b) (and “and” immediately preceding it).

(6) In paragraph (9), before “European Economic Area” insert “United Kingdom or the”.

(7) In paragraph (11)(a), before “European Economic Area” insert “United Kingdom or the”.

Amendment of regulation 47 (breach of requirement)

46.—(1) Regulation 47 is amended as follows.

(2) In paragraphs (3) and (4), before “European Economic Area”, insert “United Kingdom or the”.

(3) In paragraph (6), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation”, substitute “UK marketing authorisation, certificate of registration or traditional herbal registration”.