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The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022
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- UK Statutory Instruments
- 2022 No. 352
- Regulation 5
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Amendment of regulation 37
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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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