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        DGFT

        APPENDIX 32C - FORMAT OF CHARTERED ENGINEER (CHEMICAL) CERTIFICATE

        Foreign Trade Procedure (RE - 2012) / 2009-14 (From 5-6-2012 to 31-3-2015)

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        Chartered Engineer certification required to verify ANDA/DMF inputs and quantities for pharmaceutical export authorisations under export control. Appendix 32C mandates a Chartered Engineer (Chemical) certificate for advance authorisation applications, requiring the engineer to confirm registration and that the overseas regulator's approval pertains to the applicant's DMF or ANDA. The engineer must verify and certify technical descriptions, specifications and quantities of inputs in the ANDA/DMF against the ANF 4 J declaration, provide tabulated details comparing inputs with SION or adhoc norms, apply the specified solvent allowance rule, and accept penal liability for incorrect certification; deemed exports follow ANDA/DMF-based verification.
                          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.

                                Chartered Engineer certification required to verify ANDA/DMF inputs and quantities for pharmaceutical export authorisations under export control.

                                Appendix 32C mandates a Chartered Engineer (Chemical) certificate for advance authorisation applications, requiring the engineer to confirm registration and that the overseas regulator's approval pertains to the applicant's DMF or ANDA. The engineer must verify and certify technical descriptions, specifications and quantities of inputs in the ANDA/DMF against the ANF 4 J declaration, provide tabulated details comparing inputs with SION or adhoc norms, apply the specified solvent allowance rule, and accept penal liability for incorrect certification; deemed exports follow ANDA/DMF-based verification.


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