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Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the
request to the competent authorities for authorization of a clinical trial on a medicinal product
for human
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What is substantial amendment notification form?
The substantial amendment notification form is a document that is used to provide notification of significant changes or alterations to a previous document or agreement.
Who is required to file substantial amendment notification form?
Any individual or entity that is responsible for making substantial amendments to a document or agreement is required to file the substantial amendment notification form.
How to fill out substantial amendment notification form?
To fill out the substantial amendment notification form, you need to provide the required information such as the details of the document or agreement being amended, the nature of the amendments, and any supporting documentation.
What is the purpose of substantial amendment notification form?
The purpose of the substantial amendment notification form is to ensure that all parties involved are aware of any significant changes made to a document or agreement.
What information must be reported on substantial amendment notification form?
The substantial amendment notification form typically requires information such as the original document or agreement details, the nature of the amendments, the reasons for the amendments, and any supporting documentation.
Where do I find substantial amendment notification form?
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