- 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
18.—(1) Schedule 7 (standard provisions for manufacturing authorisations) is amended as follows.
(2) In Part 2 (provisions which may be incorporated in an authorisation relating to the manufacture or assembly of investigational medicinal products)—
(a)in paragraph 1(a), after “investigational medicinal products” insert “or EAMS medicinal products”;
(b)in paragraph 2, after “investigational medicinal products”, at each place where it occurs, insert “or EAMS medicinal products”;
(c)in paragraph 9(1)—
(i)after “investigational medicinal product” at both places where it occurs, insert “or EAMS medicinal product”, and
(ii)after “clinical trials” insert “or as part of the Early Access to Medicines Scheme”;
(d)in paragraph 10, after “investigational medicinal product” insert “or EAMS medicinal product”;
(e)in paragraph 11, after “investigational medicinal product”, at each place where it occurs, insert “or EAMS medicinal product”;
(f)in paragraph 12, after “investigational medicinal product”, at both places where it occurs, insert “or EAMS medicinal product”;
(g)in paragraph 13(2), after sub-paragraph (a) insert—
“(aa)amending the conditions attached to or revoking an EAMS scientific opinion;”;
(h)in paragraph 14, for “regulation 43(2)” substitute “regulation 43(1A) or (2)”; and
(i)after paragraph 14 insert—
“14A. The holder of the authorisation shall only manufacture or assemble EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.”.
(3) In Part 3 (provisions which may be incorporated in an authorisation relating to the importation of investigational medicinal products)—
(a)in paragraph 1, after “investigational medicinal products”, at each place where it occurs, insert “or EAMS medicinal products”;
(b)in paragraph 3, after “investigational medicinal products” insert “or EAMS medicinal products”;
(c)in paragraph 6(3)—
(i)after “investigational medicinal product”, at both places where it occurs, insert “or EAMS medicinal product”, and
(ii)after “in clinical trials” insert “or as part of the Early Access to Medicines Scheme”;
(d)in paragraph 8, after sub-paragraph (a) insert—
“(aa)amending the conditions attached to or revoking an EAMS scientific opinion;”;
(e)in paragraph 9, for “regulation 43(2)” substitute “regulation 43(1A) or (2)”; and
(f)after paragraph 9 insert—
“9A. The holder of the authorisation shall only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.”.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: