Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: Overview
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Organization: Health Canada
Published: 2022-07-28
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Objectives
This guidance helps to classify safety and efficacy changes made to new drugs that have received a Notice of Compliance (NOC) pursuant to section C.08.004 of the Food and Drug Regulations (the Regulations).
This guidance shows sponsors how to provide us with data that lets us:
- support a proposed label change
- determine the impact of the change on a new drug's safety, efficacy or effective use
Scope and application
This guidance document applies to sponsors intending to make changes to new drugs for veterinary use.
Read this guidance document in conjunction with:
- Post-Notice of Compliance changes: Framework document for veterinary drugs
- Post-Notice of Compliance changes: Quality guidance
- A revised guidance for veterinary drugs is currently under consultation: Post-Notice of Compliance changes: Draft guidance for quality of veterinary drugs
Learn more about:
Background
This guidance applies to drugs for veterinary use only. This guidance document replaces the provisions in the Post-Notice of Compliance changes: Safety and efficacy document (2015).
Note about guidance documents in general
Guidance documents help industry and health care professionals comply with governing statutes and regulations. They also show Health Canada staff how to fairly, consistently and effectively meet mandates and objectives.
Guidance documents are administrative instruments, not legal ones. This means that they allow for flexibility. However, you must support alternate approaches to the principles and practices described in this document with adequate justification for Health Canada to accept them. Discuss your approaches with the relevant program area in advance to make sure you meet all statutory and regulatory requirements.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document. This helps us adequately assess the safety, efficacy or quality of a therapeutic product. We're committed to ensuring that such requests are justifiable and that we clearly document our decisions.
You should read this document along with the relevant sections of the Regulations and other applicable guidance documents
- The other applicable guidance documents are listed above under Scope and Application and Guidance for Industry: Preparation of Veterinary New Drug Submissions