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        Appendix-04L - Format of Chartered Engineer (Chemical) Certificate

        Foreign Trade - Handbook of Procedures, 2023
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        Chartered Engineer certification requirement ensures inputs and DMF/ANDA alignment before advance authorisation for pharmaceutical exports. A Chartered Engineer (Chemical) Certificate must link the importing country regulatory approval to the applicant's DMF/ANDA and certify that inputs, specifications and quantities declared in ANF 4E match those in the DMF/ANDA after technical scrutiny; the certificate lists products and inputs with technical particulars and SION/adhoc norms, notes solvent allowance and deemed export provisions, and warns that incorrect certification attracts penal action under the Foreign Trade (Development & Regulation) Amendment Act and related rules.
                          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 requirement ensures inputs and DMF/ANDA alignment before advance authorisation for pharmaceutical exports.

                                A Chartered Engineer (Chemical) Certificate must link the importing country regulatory approval to the applicant's DMF/ANDA and certify that inputs, specifications and quantities declared in ANF 4E match those in the DMF/ANDA after technical scrutiny; the certificate lists products and inputs with technical particulars and SION/adhoc norms, notes solvent allowance and deemed export provisions, and warns that incorrect certification attracts penal action under the Foreign Trade (Development & Regulation) Amendment Act and related rules.


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