Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: Documentation

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Health Canada is responsible for:

This section highlights the range in categories of data and contextual information that may be relevant to the evaluation of a particular submission.

We can optimize our regulatory decision‐making if you provide us with contextual information, such as:

This will help to minimize delays that can result when a submission is silent on a relevant topic. Health Canada may accept alternate approaches to the principles and practices described in this document if they're supported by adequate justification.

Include or comment on the recommended data in the submission package for Level 1 and 2 changes, where applicable.

Filing formats for submitting supporting data

Prepare and file the data that supports the changes as prescribed in:

Supporting data for Level 1 and 2 changes

Provide clinical and/or non-clinical study data relevant to the submission. This may include but is not limited to:

Provide other data which may be relevant to the submission. This may include, but is not limited to:

Where applicable, sponsors should submit a complete set of labelling in both official languages, including:

Submit these labels as an annotated electronic copy of the labels in a Microsoft Word document with tracked changes, comparing the previous approved labelling version. This includes tracking in a new version date, which should appear in the footer or header of each page.

If you provide the proposed labelling as a PDF, you must submit an annotated and non-annotated version. In the annotated version:

Provide supporting data and explanations for the proposed changes in a separate document within the submission.

Contextual information

Contextual information may include copies of the most recent labels authorized in other major regulatory jurisdictions. These jurisdictions must be within the International Council for Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), including:

Contextual information may also include:

For subsequent entry products (generic drugs), include the revision date of the package insert of the Canadian reference product used in preparation of the generic sponsor's package insert.

Additional contextual information: Level 1 changes

Include the current submission status with other major VICH regulatory jurisdictions. For example, at the time of submitting the proposed change to Health Canada, specify if the changes are:

If other major VICH regulatory jurisdictions have finished their review, include a:

Where available, include copies of any foreign review reports, correspondence or communications (including questions and answers) which may be relevant to the submission.

If other major VICH regulatory jurisdictions have not completed their review, include a summary of any significant issues being raised.

Additional contextual information: Level 2 changes

Additional contextual information can include:

Include the most recent electronic or hard copy of the Periodic Safety Update Reports. Health Canada can cross-reference them against previous versions, if relevant.

Supporting data for Level 3 changes

Do not submit any data that supports a Level 3 change with your notification. However, make sure it is available to Health Canada within 30 calendar days of a request.

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