Summary: Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs

From: Health Canada

Date adopted: 2017/10/27
Date posted: 2020/10/01
Effective date: 2020/10/01


To clarify the requirements for eligible drug submissions and applications that will be processed under the administrative pathway.

Who this guide is for

  1. Members of the pharmaceutical industry wishing to file drug submissions under the administrative pathway
  2. Members of the public wishing to understand the process for filing drug submissions under the administrative pathway

View complete guide

PDF version (315 KB, 24 pages)

For assistance

Contact us:

Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Finance Building,
101 Tunney’s Pasture Driveway
Ottawa, ON K1A 0K9 A.L. 0202B

Telephone: 613-941-2566
Fax: 613-941-1183

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