PART 15Consequential Amendments

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 200455

1

The Medicines for Human Use (Clinical Trials) Regulations 200425 are amended as follows.

2

In regulation—

a

17(2)(b)(ii) (request for authorisation to conduct a clinical trial),

b

24(10) (amendments by the sponsor),

c

38(3)(b) (application for manufacturing authorisation),

d

44(8) (variation of manufacturing authorisation),

for “Medicines (Products for Human Use) (Fees) Regulations 2010” substitute “Medicines (Products for Human Use) (Fees) Regulations 2012”.

Amendment of the Homoeopathic Regulations56

The Homoeopathic Regulations are amended by omitting the following definitions in regulation 1(2)26 (citation, commencement and interpretation)—

a

“administrative variation”,

b

the Board”,

c

“concerned member State”,

d

“set of applications”, and

e

“standard variation”.