The Human Medicines Regulations 2012

69.—(1) The Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989(1) 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”.

(1)

S.I. 1989/684, as amended by S.I. 1995/871, S.I. 2004/1031 and S.I. 2005/2754. There are other amendments, but none is relevant.