DGFT clarifies about the technical details to be submitted in Appendix 4E for Chemical Products ,Drugs and Pharmaceuticals.

May 14, 2018 | by Avantis RegTech Legal Research Team

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General Compliance

Director General of Foreign Trade vide trade notice dated May,14,2018 has clarified  the technical details to be submitted  containing technical details, chemical reactions and data sheet for advance authorisation applications on self declaration basis which  reads as follows-

·         The applicant shall submit complete documents as provided in Appendix 4B which include step-wise manufacturing process, complete chemical reactions with molecular and structural formula and molecular weights along with stage wise % yields on molar basis, material balance, requirement and recovery of solvents, details of byproduct/co—products formed, percentage purity of finished product, standard technical literature, etc., wherever applicable.

·         Applicants are requested to ensure that all relevant documents are forwarded to the Norms Committee in time so that the cases are processed in a time bound manner.

[Trade Notice 07/2018-19]



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