Amendment of Schedule 414
1
Schedule 4 (standard provisions of licences under Part 3) is amended as follows.
2
After paragraph 14A17, insert—
14B
A licence holder may 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 paragraph 2218—
a
in sub-paragraph (5), after “special medicinal products” insert “or EAMS medicinal products”
;
b
in sub-paragraph (7), after “special medicinal product” insert “or EAMS medicinal product”
;
c
in sub-paragraph (8) after “special medicinal product” insert “or EAMS medicinal product”
; and
d
in sub-paragraph (9), after “special medicinal product” insert “or EAMS medicinal product”
.
4
After paragraph 23A19, insert—
23B
A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.
5
After paragraph 33, insert—
33A
A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.
6
In paragraph 37, after “special medicinal products” insert “or EAMS medicinal products”
.
7
In paragraph 39, after “special medicinal product” insert “or EAMS medicinal product”
.
8
In paragraph 40, after “special medicinal product” insert “or EAMS medicinal product”
.
9
In paragraph 41, after “special medicinal product” insert “or EAMS medicinal product”
.