Summary: Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
Date adopted: 2017/10/27
Date posted: 2020/10/01
Effective date: 2020/10/01
Overview
To clarify the requirements for eligible drug submissions and applications that will be processed under the administrative pathway.
Who this guide is for
- Members of the pharmaceutical industry wishing to file drug submissions under the administrative pathway
- Members of the public wishing to understand the process for filing drug submissions under the administrative pathway
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
Email: hc.bgivd.enquiries.sc@canada.ca
Useful Resources
- Administrative Certification Form For Human or Disinfectant Drugs
- Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs
- Guidance Document: Questions and Answers: Plain Language Labelling Regulations for non- Prescription Drugs
- Guidance Document: Management of Drug Submissions and Applications
Related acts and regulations
Page details
- Date modified: