69.—(1) The Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 M1 is amended as follows.U.K.
(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 ”.
Marginal Citations
M1S.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.