Type-II Variation [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2024-07-02 11:37 (15 d 16:16 ago) – Posting: # 24053
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Hi QA,

IMHO, this is Type-II Variation (according to the EMA’s Q&Aa change that may have a significant impact on the quality, safety or efficacy of the medicinal product’), and, thus, an in-vivo study is required. See also EC 2013/C 223/01, Section B.II.b.3.b).

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