53. In regulation 2(1) (interpretation)—U.K.
(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—
the Commission on Human Medicines; or
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,”; and
(f)for the definition “medicinal product” substitute—
““medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.”