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

On this page

• Filing formats for submission supporting data
• Supporting data for Level 1 and 2 changes
• Contextual information
• Additional contextual information: Level 1 changes
• Additional contextual information: Level 2 notifiable changes
• Supporting data for Level 3 changes

Health Canada is responsible for:

• assessing drug submissions received for a changes to new drugs
• making decisions based on evidence and context within a specified time frame

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:

• the sponsor's interpretation of the data
• the interpretation by other major international agencies (for example, as per labels approved by that jurisdiction)
• information that no other major agency has rendered an opinion on at the time of the evaluation or if discussions are currently underway
• characterization of the treated population in question
• regional clinical practice standards
• the availability of alternative therapies
• The presence of an information category in these lists does not necessarily mean the data is required. However, when a specific topic is relevant to a submission, the sponsor should acknowledge and address it by providing the information or a rationale as to the absence of the information.

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:

• Guidance for Industry: Preparation of Veterinary New Drug Submissions
• Guidance Document: Preparation of regulatory activities in non‐eCTD format

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:

• bioequivalence studies
• risk management plans
• pharmacokinetic studies
• pharmacodynamic studies
• pharmacovigilance plans
• pharmacovigilance studies
• epidemiological data and study results
• Periodic Safety Update Report data
• clinical studies (whether focused on efficacy or safety)
• review reports and analyses of specific safety concerns

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

• rationales
• real world information regarding drug use
• publications in peer‐reviewed scientific journals
• conference presentations
• drug utilization information
• opinion papers
• declarations and attestations

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

• inner labels
• outer labels
• package insert
• all sizes of labels

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:

• highlight additions to the text
• indicate deletions using strikeouts
• make sure there are no comment bubbles

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:

• NZ Ministry for Primary Industries
• UK Veterinary Medicines Directorate
• European Union European Medicines Agency
• Australian Pesticides Veterinary Medicines Authority
• US Food and Drug Administration Center for Veterinary Medicine

Contextual information may also include:

• relevant correspondence or communications from other major VICH regulatory jurisdictions or
• a statement confirming that such communications have not been required by any authorities

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:

• rejected
• approved
• not submitted
• currently under review

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

• summary of any significant issues raised and how they were addressed and resolved, or
• statement confirming that there were no significant issues identified by those authorities

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:

• wording of any related instructions or communications to veterinarians that may have been or is currently required in other major VICH regulatory jurisdictions or
• a statement confirming that authorities do not require such instructions or communications

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.