SCHEDULES

SCHEDULE 34Amendments to existing law

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

62

In Schedule 7 (standard provisions for manufacturing authorisations)—

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 ”.