Part 12Amendment to the Schedules

Amendment to Schedule 5

regulation 41 + 41.—(1) Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials) is amended as follows.

(2) In paragraph 1(1), for “regulation 26(1)” substitute “regulation 23(2)”.

(3) In paragraph 2—

regulation 41 3 a + (a)in sub-paragraph (1)—

regulation 41 3 a i + (i)in the opening words, for “an amendment to the clinical trial authorisation” substitute “a substantial modification”;

regulation 41 3 a ii + (ii)in paragraph (a), for “amendment” substitute “modification”;

regulation 41 3 a iii + (iii)in paragraph (b), for “amendment to the clinical trial authorisation” substitute “modification”;

regulation 41 3 b + (b)in sub-paragraph (2), for “notice of amendment to a clinical trial authorisation” substitute “valid modification request”.