Paragraph 53

before the definition “the Act” insert the following definition—

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

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—

1. (a)

   the Commission on Human Medicines; or

2. (b)

   an expert committee appointed by the licensing authority;”;

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;”;

in the definition “licensing authority” for “section 6 of the Act” substitute “ regulation 6 of the 2012 Regulations ”;

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

for the definition “medicinal product” substitute—

““medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.”