Guidance for completing the Drug Submission Application Form

Description

For Drug Identification Number applications, a separate completed HC/SC 3011 must be provided for each formulation, strength and dosage form. For all other submission types, only a separate completed Part 2 must be provided for each formulation, strength and dosage form.

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Name Format Description Link
Guidance for completing the Drug Submission Application Form HTML Open resource
Guidance for completing the Drug Submission Application Form HTML Open resource

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