# The Human Medicines Regulations 2012, Paragraph 53


In regulation 2(1) (interpretation)—
(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—
(a)the Commission on Human Medicines; or
(b)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.”

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/34/paragraph/53 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-34/paragraph-53
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.