Consultation on Post-Notice of Compliance changes: Draft guidance for quality of veterinary drugs
From Health Canada
Current status: Open
Opened on July 28, 2022 and will close to new input on September 26, 2022.
Health Canada is seeking feedback on a proposed draft guidance document for veterinary drug industry which has been transitioned from the Appendix 2 of the current Post-Notice of Compliance (NOC) Changes: Quality Document. The proposed draft guidance is intended to provide:
- guidance specific to veterinary drugs for easy and efficient navigation
- sufficient information on filing or notifying any post-market quality changes to veterinary drugs
- examples that help identify proposed quality changes with proper reporting categories and corresponding supporting data
The outcome will be a final guidance document that assists industry in classifying changes that affect product quality and submitting the appropriate supporting information, as applicable.
Join in: how to participate
- Email us to request a copy of the Post-notice of compliance (NOC) changes: Draft guidance for quality of veterinary drugs.
- Email us your feedback with the subject line "Comments: Consultation on Post-notice of compliance (NOC) changes: Draft guidance for quality of veterinary drugs".
Who is the focus of this consultation
This consultation is intended for veterinary drug industry stakeholders.
Key questions for discussion
We are seeking feedback to ensure that this technical guidance is as clear as possible.
- Post-Notice of compliance (NOC) changes: Framework document for veterinary drugs
- Post-Notice of compliance (NOC) changes: Guidance for safety and efficacy of veterinary drugs
- Veterinary drugs - Management of regulatory submissions guidance
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