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

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This section of the guidance provides criteria and examples to help you classify a safety or efficacy related change. Examples are not exhaustive and are meant to provide guidance on types of acceptable changes.

Contact the Veterinary Drugs Directorate submission office if you have questions or need help.

Level 1 changes: Supplements


Level 1 changes are changes to a new drug that are "significantly different" as it relates to the matters specified in C.08.003 (2) of the Regulations. These are changes to the label of a drug that have the potential to increase the exposure levels of the drug, either by:

Label changes that can result in increased exposure levels of the drug include the:

This level also includes changes that don't meet the above criteria, but require the filing of a Level 1 change as per C.08.003 and C.08.005.1 of the Regulations. Examples include:

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Examples of Level 1 changes include but are not limited to the following:

Changes to label text

Health Canada initiated label changes that may include, but are not limited to:

Changes to existing label text that reference any potential benefits of the drug (implied or explicit), including references to:

An existing contraindication, warning or cautionary text anywhere in the package insert that has been:

Note: changes from existing contraindications, warnings or cautionary texts may result from a range of supporting data, such as post‐marketing data, safety studies and pharmacokinetic data.

Reordering text on the label necessary for the safe and effective use of the product, such as:

Examples of other label text changes may also include:

Changes based on new data

These changes can include, but are not limited to, the addition of:

Other examples of these changes can also include:

Changes to label design

Changes to label design can include, but are not limited to:

Submission filing

File changes included in this reporting category, along with the recommended supporting data, with Health Canada as a:

Do not implement Level 1 changes until you receive a NOC.

Level 2 changes: Notifiable changes


A Level 2 notifiable change is a change to the label that could improve the management of risks or harms to the population currently indicated for use of the drug, or in any other way exposed to the drug by:


Examples of Level 2 changes include, but are not limited to:

Changes to label text

Text additions that strengthen or clarify information anywhere in these labelling sections:

These additions may include recommended risk or harm management actions such as:

These additions may also include the identification that a specific sub‐population is at greater risk, such as:

These changes can also include:

Changes based on new data

Examples of these changes can include, but are not limited to:

Submission filing

File any changes included in this reporting category to Health Canada as a Level 2 notifiable change. Include your recommended supporting data. Sponsors should not implement Level 2 changes until issued with a No Objection Letter.

Note: Some changes that meet the Level 2 criteria may require sponsors to file a Level 1 change.

Level 3 changes: Annual notifications


Level 3 or annual notifications are changes to a label that have minimal potential to impact the safety, efficacy or effective use of the drug. Sponsors can implement changes included in this reporting category without Health Canada reviewing the data supporting such a change beforehand.


Examples of Level 3 related changes include but are not limited to:

For non‐prescription drug products, examples of Level 3 changes include but are not limited to the following non‐significant label changes:

Submission filing

File your notification of a Level 3 label change:

Only submit a copy of revised annotated labels and package inserts when you file the next Level 1 or 2 changes that necessitate a label or quality change as well. Clearly identify the implementation dates for these Level 3 changes.

Do not submit supporting data for Level 3 changes recommended in this guidance document. However, the data should be available to Health Canada within 30 calendar days of a request.

File your changes using the Post-Notice of Compliance changes: Level 3 form.

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