Notice: Revised guidance documents on Post-Notice of Compliance changes for veterinary drugs

Health Canada is releasing 3 associated revised guidance documents on Post-Notice of Compliance (NOC) changes for veterinary drugs. Note that documents related to drugs for human use are published separately.

These 2 veterinary documents are final and in effect as of the publication date of this notice:

1. Post-Notice of Compliance changes: Framework document for veterinary drugs
2. Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs

This document is a draft for consultation:

3. Post-Notice of Compliance changes: Draft guidance for quality of veterinary drugs

Framework document

This final version of the framework document replaces the "Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document" that had been in effect until March 31, 2020. It links to the safety and efficacy document and quality document, and provides:

• the general classification of post-NOC changes
• general recommendations for supporting documentation
• the basic framework for post-NOC changes for veterinary drugs

Note that the current reporting categories remain the same. Since we have made no substantive revisions, we are not seeking comments at this time.

Safety and efficacy document

This final version of the safety and efficacy document replaces the "Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document" that had been in effect until March 31, 2020. It provides:

• information about the classification of post-NOC safety and efficacy changes
• recommendations for data to support proposed changes to veterinary drugs

Minor revisions include:

• clarification of the conditions for the classification of a change
• clarification of the supporting data for each reporting category

Since we have made no substantive revisions, we are not seeking comments at this time.

Quality document (draft guidance for consultation)

The final quality document will replace Appendix 2 of the "Post-Notice of Compliance (NOC) Changes - Quality Guidance" published in September 2009. It provides information about the:

• classification of post-NOC quality changes
• recommendations for data to support proposed changes to veterinary drugs

Major revisions for consultation are:

• the addition of new quality-related post-NOC change examples
• revisions to conditions and supporting data to provide clear requirements for different reporting categories

Refer to the document change log in the draft document for further details.

The draft guidance is available upon request from Health Canada. Contact us for a copy and to provide feedback. The subject line of your feedback should include "Comments: Consultation on draft Post-Notice of Compliance changes: Guidance for quality of veterinary drugs".

Email: consultationvdd-dmv@hc-sc.gc.ca

The consultation will close on September 26, 2022.