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SCHEDULES

SCHEDULE 34U.K.Amendments to existing law

PART 4U.K.The Medicines for Human Use (Clinical Trials) Regulations 2004

62.  In Schedule 7 (standard provisions for manufacturing authorisations)—U.K.

(a)in Part 2—

(i)in paragraph 5 for “the Act” substitute “ the 2012 Regulations ”,

(ii)in paragraph 9 for “the Act or any regulations under the Act” substitute “ or the 2012 Regulations ”, and

(iii)in paragraph 13—

(aa)for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb)for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”; and

(b)in Part 3—

(i)in paragraph 6 for “the Act” in the first place where it occurs substitute “ the 2012 Regulations ”, and

(ii)in paragraph 8—

(aa)for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb)for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”.