- Draft legislation
This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument: The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 No. 352
4. In regulation 8(1)(1) (general interpretation), at the appropriate places insert—
““EAMS medicinal product” means a medicinal product that—
has been included in the Early Access to Medicines Scheme by means of the licensing authority issuing an EAMS scientific opinion in respect of it; and
remains in the scheme by virtue of the EAMS scientific opinion not ceasing to have effect in respect of it by virtue of regulation 167D;”;
““EAMS scientific opinion” is to be construed in accordance with regulation 167C(2)(b);”;
““EAMS scientific opinion holder” means the holder of a EAMS scientific opinion, and accordingly, is the person who places on the market the product to which the opinion relates;”;
““Early Access to Medicines Scheme” means the scheme of that name established and operated under regulation 167C(1);”; and
““EU Clinical Trials Regulation” means Regulation EU No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products, and repealing Directive 2001/20/EC(2);”.
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