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Regulation 158 Amendment of regulation 198 (post-authorisation safety studies: general provisions)

Original text. Later amendments are not shown.

(1)

Regulation 198 is amended as follows.

(2)

In paragraph (2), for “competent authorities of the EEA States in which the study is conducted” substitute “licensing authority”.

(3)

In paragraph (3)—

(a)

in sub-paragraph (c), for “relevant competent authorities” substitute “licensing authority”;

(b)

in sub-paragraph (d), for “competent authorities of the EEA States in which the study was conducted” substitute “the licensing authority if the study is conducted in the United Kingdom”.