The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 130 (consideration of application)

This section has no associated Explanatory Memorandum

116.—(1) Regulation 130 is amended as follows.

(2) In paragraph (6), insert “UK” before “marketing authorisation”.

(3) In paragraph (7), for “Article” to the end substitute “regulation 130A.”.

(4) In paragraph (8), for “list referred to in Article 16f(1) of the 2001 Directive” substitute “relevant list”.

(5) Omit paragraph (9).

(6) In paragraph (10)(a) for “Article 16h(3) of the 2001 Directive” substitute “regulation 143A”.

(7) Omit paragraphs (12) and (13).