SCHEDULES

SCHEDULE 34Amendments to existing law

PART 5Other United Kingdom, Scotland and Wales Secondary legislation

Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989

69

1

The Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 M1 is amended as follows.

2

In article 1(2) insert after the definition “ the 1987 Act ” the following definition—

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

3

In Schedule 1—

a

in paragraph 1 omit “, II” and “, VI”;

b

after paragraph 1 insert the following paragraph—

1A

Functions of the Ministers under the 2012 Regulations (except those under Part 15 (British Pharmacopeia) of those Regulations), subject to paragraph 11 below.

c

in paragraph 2 for “Part II of the 1968 Act “ substitute “Parts 3 to 8 of the 2012 Regulations”;

d

for paragraph 3 substitute—

3

Functions of the Commission on Human Medicines, whose continuation is provided for in regulation 9 of the 2012 Regulations (except those under Part 15 (British Pharmacopoeia) of those Regulations).

e

for paragraph 4 substitute—

4

Functions of any expert committee appointed by the licensing authority under the 2012 Regulations.

f

for paragraph 8 substitute—

8

Functions of reviewers appointed under the 2012 Regulations.

g

omit paragraphs 9A, 9C and 9D;

h

in paragraph 10(c) for “and of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ and of the 2012 Regulations ” and

i

in paragraph 11—

i

after “Paragraphs 1” insert “ , 1A ”, and

ii

after “under it” insert “ or under the 2012 Regulations ”.