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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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:

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:

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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

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