Regulation 11 Amendment of regulation 60B (submitting of samples and other information: EU marketing authorisations)
(1)
Regulation 60Bf1 is amended as follows.
(2)
In paragraph (1), in the definition of “the batch testing exemption”, in paragraph (b)(ii), after “United Kingdom” insert “or the European Union”
(3)
In paragraph (2)(a), in each place where it occurs, for “immunological product” substitute “immunological medicinal product”.
Annotations
Footnotes
- f1
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Regulation 60B was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).