Submission of information in conformity with provisions contained in Annexure I to Appendix 10 of Hand Book of procedures (Vol.I) in respect of applications for grant of Advance Licences under Para 4.7 of Hand Book of Procedures (Vol.I)
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Advance licence documentation compliance: submit Annexure I technical and licence documents or risk administrative return of application.
Submission of complete technical and commercial information in conformity with Annexure I to Appendix 10 is required for Advance Licence applications under Para 4.7. The Advance Licensing Committee noted deficiencies, especially non submission of Annexure I documents for Chemicals & Plastics and missing self certified Drug Manufacturing Licence copies. A revised Annexure I checklist is attached; applicants must provide the specified product specific technical disclosures, process flow, material balances, yields, solvent recovery, purity data and relevant licences, otherwise applications may be returned or rejected.