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Schedule D, Schedule D(I), Schedule D(II)

Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y

Schedule D (Rule 43) is related to import of drugs into India. Schedule D provides information about extent and condition of exemption for a class of drug in case of import.

Schedule D(I)(Rule 21D and 24A): Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40.

The detailed information, secret in nature, may be furnished on a Computer Floppy.

Schedule D(II) (Rule 21D and 24A): Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India.

The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy.

Annexure A: Information to be Submitted In Schedule D-II: Specific information required for the Blood Product

Annexure B: Information to be submitted in schedule D-II: specific information required for the diagnostic kits

Annexure C: Information to be submitted in schedule D-II: Specific information required for the vaccines

Schedule D(III)(Rule 129A): Information and undertaking required to be submitied by the manufacturer or his authorised importer/distributor/agent with the application form for a registration certificate.


For more detail refer Drug and Cosmetic Act
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