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Non-submission of complete Appendix 4E, containing technical details, chemical reactions and data sheet for advance authorisation applications on self declaration basis under Para 4.04 and 4.07 of HBP for cases relating to NC-4
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Appendix 4E compliance requires full technical disclosure to prevent deferment of chemical advance authorisation applications. Non-submission of complete Appendix 4E is causing deferment of advance authorisation applications for chemicals filed on a self declaration basis. Applicants must provide step wise manufacturing processes, full chemical reactions with molecular and structural formulas and weights, stage wise molar yields, material balance, solvent requirement and recovery, by product/co product details, finished product purity and standard technical literature so Regional Authorities can forward complete dossiers to the Norms Committee for time bound processing.
Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
Provisions expressly mentioned in the judgment/order text.
Appendix 4E compliance requires full technical disclosure to prevent deferment of chemical advance authorisation applications.
Non-submission of complete Appendix 4E is causing deferment of advance authorisation applications for chemicals filed on a self declaration basis. Applicants must provide step wise manufacturing processes, full chemical reactions with molecular and structural formulas and weights, stage wise molar yields, material balance, solvent requirement and recovery, by product/co product details, finished product purity and standard technical literature so Regional Authorities can forward complete dossiers to the Norms Committee for time bound processing.
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