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Amendment to regulation 189

80.  In regulation 189 (signal detection: licensing authority obligations)(1)—

(a)in paragraph (2), for the words from the beginning to “UKMA(UK)” substitute “In relation to medicinal products subject to a UKMA(UK)(Category 2)”;

(b)in paragraph (3), for the words from the beginning to “UKMA(UK)” substitute “In relation to medicinal products subject to a UKMA(UK)(Category 2)”.

(1)

Paragraphs (2) and (3) of regulation 189 were amended by S.I. 2019/775 as amended by S.I. 2020/1488; there was a typographical error in those amendments which is rectified by these amendments.