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RegisterType-II Variation [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2024-07-02 11:37 (325 d 11:10 ago) – Posting: # 24053
Views: 2,503
Hi QA,
IMHO, this is Type-II Variation (according to the EMA’s Q&A ‘a 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).
IMHO, this is Type-II Variation (according to the EMA’s Q&A ‘a 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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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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Ing. Helmut Schütz