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FIEF SAMENESS FORM References: ECHO “Guidance on preregistration and data sharing (Sept 2007×, section 4.5.1 ECHO “Guidance for identification and naming of substances under Reach “, p.88 (Section
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What is sief sameness form?
Sief sameness form is a form used to report any changes in manufacturing processes or specifications of a drug product.
Who is required to file sief sameness form?
Manufacturers, sponsors, or applicants of drug products are required to file sief sameness form.
How to fill out sief sameness form?
Sief sameness form can be filled out electronically or on paper and requires detailed information about the changes in manufacturing processes or specifications.
What is the purpose of sief sameness form?
The purpose of sief sameness form is to ensure that any changes made to drug products do not affect their safety, efficacy, or quality.
What information must be reported on sief sameness form?
Information such as the nature of the changes, rationale for the changes, and any supporting data must be reported on sief sameness form.
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