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        DGFT

        Appendix -4L - FORMAT OF CHARTERED ENGINEER (CHEMICAL) CERTIFICATE

        Foreign Trade Procedure 2015-2020 (From 5-12-2017 to 31-3-2023) Revised

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        Chartered Engineer Certification verifies ANDA/DMF conformity with export inputs and triggers liability under FTP Act for inaccuracies. Chartered Engineer (Chemical) certifies that the exporting pharmaceutical product and its inputs conform to the importing regulatory approval referencing the DMF/ANDA, and that technical descriptions, specifications and quantities in ANF 4E match those in the DMF/ANDA. The certificate requires tabulated product and input details, comparison with SION/adhoc norms (or 'NIL'), and adherence to the solvent allowance rule. The engineer confirms verification of approvals and inputs and acknowledges penal liability for any incorrect statements; deemed export certification uses recipient ANDA and supplier DMF.
                          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 verifies ANDA/DMF conformity with export inputs and triggers liability under FTP Act for inaccuracies.

                                Chartered Engineer (Chemical) certifies that the exporting pharmaceutical product and its inputs conform to the importing regulatory approval referencing the DMF/ANDA, and that technical descriptions, specifications and quantities in ANF 4E match those in the DMF/ANDA. The certificate requires tabulated product and input details, comparison with SION/adhoc norms (or "NIL"), and adherence to the solvent allowance rule. The engineer confirms verification of approvals and inputs and acknowledges penal liability for any incorrect statements; deemed export certification uses recipient ANDA and supplier DMF.


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