PART 2Amendment of the Human Medicines Regulations 2012
Amendment of regulation 60B (submitting of samples and other information: EU marketing authorisations)11
1
Regulation 60B12 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”
.