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Information required in an evaluation of a substance for use in listed medicines: guidance for sponsors

Formerly included in ARGCM V 8.0 Part C
20 May 2020
Download Information required in an evaluation of a substance for use in listed medicines: guidance for sponsors

Description

Guidance for sponsors on the information required in an application for evaluation of a substance for use in listed medicines:

  • Application format
  • Administrative information
  • Information required to demonstrate the quality of substance(s) for use in listed medicines
  • Information required to demonstrate safety of a substance for use in listed medicines
  • Compositional guidelines for listed medicine ingredients

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