Notice: Revisions to the Administrative Guidance Document

June 28, 2019
Our file number: 19-111818-14

Health Canada revised the Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs. This document provides information for industry on how submissions and applications involving human or disinfectants drugs may be submitted for administrative processing.

The guidance is being updated at this time to clarify submission requirements for submissions processed administratively. Minor updates were made throughout to clarify requirements and update outdated information (e.g., contact information and web links). In addition, the following additions were made to clarify:

• That for all drug submissions and applications for cross-licensed products, an Administrative Certification Form and a Letter of Authorization must be filed when applicable;
• Requirements around when a Drug Notification form is required and when it will be issued/reissued; and
• Labelling requirements including that for cross licensed products where an administrative submission is filed for labelling updates to match the licensor, mock ups do not need to be filed if certain parameters are met (refer to section 2.6).

This guidance document comes into effect immediately. Questions or concerns related to this guidance document should be directed to:

Bureau of Gastroenterology, Infection and Viral Diseases
Health Products and Food Branch
Therapeutic Products Directorate
Address Locator: 0201A1
101 Tunney's Pasture Driveway
Ottawa Ontario
K1A 0K9

Email: hc.bgivd.enquiries.sc@canada.ca
Telephone: 613-941-2566
Fax: 613-941-118