SCHEDULES

SCHEDULE 34Amendments to existing law

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

53

In regulation 2(1) (interpretation)—

a

before the definition “the Act” insert the following definition—

“the 2012 Regulations” means the Human Medicines Regulations 2012;

b

for the definition “appropriate committee” substitute—

“appropriate committee” for the purposes of any provision of these Regulations under which a function falls to be performed means whichever the licensing authority considers to be appropriate of—

  1. a

    the Commission on Human Medicines; or

  2. b

    an expert committee appointed by the licensing authority;

c

insert in the appropriate position in alphabetical order the following definition—

    • “the Commission on Human Medicines” means the Commission on Human Medicines within the meaning of regulation 9 of the 2012 Regulations;

d

in the definition “licensing authority” for “section 6 of the Act” substitute “ regulation 6 of the 2012 Regulations ”;

e

for sub-paragraph (a) of the definition “marketing authorisation” substitute—

a

a UK marketing authorisation granted by the licensing authority under the 2012 Regulations,

f

for the definition “medicinal product” substitute—

“medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.