HI All,
I was readying the "fundamentals of pharmaceutical and Biologics 3rd edition, and it mentions that when submitting substantial amendment to needs to be assessed by national authority only, one should also notify Ethic Committee, however, in the Communication from the commission 2010/C 82/01, it says if the substantial amendment only goes to national authority, only should only notify national authority. notification ' for Information only ' is not necessary.
Could someone be so kind to clarify this part, or what is the best practice ? (we have always submit a notice to EC whenever we have a substantial amendment to national competent authority)
thank you
Best,
Kristy
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Kristy Lu
San Diego CA
United States
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