PART 11Amendment of Part 11 (Pharmacovigilance)
Amendment of regulation 199 (submission of draft study protocols for required studies)I1159
1
Regulation 199 is amended as follows.
F12
In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute—
to—
a
the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation is a UKMA(NI) or UKMA(UK);
b
the licensing authority, where the authorisation is a UKMA(GB),
before the study is commenced.
F23
In paragraph (4)—
a
after “protocol is submitted” insert “only”;
b
after “paragraphs (2) and (3)(a)” insert “(and is not submitted to the Pharmacovigilance Risk Assessment Committee)”.
F34
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F35
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F36
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