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Literature-based submissions for listed medicines and registered complementary medicines

Formerly included in ARGCM V.8 Part A
20 May 2020
Download Literature-based submissions for listed medicines and registered complementary medicines

Description

Guidance for sponsors and applicants on using literature based submissions for applications for listed medicine and registered complementary medicines:

  • When a literature submission can be used
  • Requirements for a literature based submission
  • Conducting the literature search

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