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The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022
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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
Amendment of regulation 37
5.—(1) Regulation 37(1) (manufacturing and assembly) is amended as follows.
(2) In paragraph (6)—
(a)omit “and” at the end of sub-paragraph (a); and
(b)after sub-paragraph (a) insert—
“(aa)in the case of a product for supply as an EAMS medicinal product, the conditions attached to the EAMS scientific opinion in respect of the product; and”.
(3) In paragraph (10), after “applies” insert “or an EAMS medicinal product to which regulation 167E(1) to (4) (EAMS medicinal product: manufacture, assembly, importation, distribution and supply) applies”.
(1)
Amended by S.I. 2013/1855, 2019/775 and 2021/1452.
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