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All the information mentioned in this guidance must be summited as full text and summarized in:
- Form (A) for General Requirement.
- Form (B) for EEs Requirement.
Forms are attached in the appendix should be to be submitted to the SFDA as part of the eCTD section 1.8.2 (Other documents related).
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Disclaimer: Translation into other languages depends on the Google translation, Therefor the NCC is not responsible for the accuracy of the information in the new language.