Label Safety Assessment Update - Sponsor Attestation

Brand (Proprietary) Name of Drug Product:

Proper, Common or Non-proprietary Name of Drug Substance:

Proper, Common or Non-proprietary Name of Drug Substance:

Manufacturer / Sponsor:

Dosage Form(s) and Strength(s):

Reason for Submission: (Response to Advisement dated: MM/DD/YYYY or as per innovator control number XXXXXX)

Summary of Product Labelling Information

Confirm that the following required documents are included:

Annotated and non-annotated Product Monograph (PM) provided (including eCopy)?

• Yes
• No

Document compare performed (Results of document compare must be summarized in the tables below):

• Yes
• No

Against most recent Canadian Reference Product (CRP) PM (dated: MM/DD/YYYY)
Against most recently approved PM for this product (dated: MM/DD/YYYY)

Have inner and/or outer package labels been updated?

• Yes (Please include in submission)
• No (Please include in submission)

Justification (if required):

Description of Proposed Labelling Changes

Document compare against the most recent CRP shows that the Product Monograph has been updated in the following way:

1. There are no differences other than the product brand name and product specific sections (ex. Comparative bioavailability summary table(s), pharmaceutical information, storage and stability, non-medicinal ingredients, references).

And/or:
2. The Product Monograph excludes sections of the CRP's Product Monograph due to a difference in market authorized dosage forms, dosing and administration, strengths and/or indications, which have been previously approved.

And/or:
3. The Product Monograph includes other information, not previously approved, that is different from the CRP Product Monograph.
Attestation

We attest that the proposed revisions to the Product Monograph for <Insert product name > submitted by <Insert sponsor name > contain only the changes outlined.

<Insert name>
<date>
<Title>
<Company>

Document Compare 1:
Summary of differences between proposed PM and most recent Canadian Reference Product PM:

Part I: Health Professional Information
New Product Monograph Format:
Difference:
Justification for Differences:

• Summary Product Information
• Indications and Clinical Use
• Contraindications
• Warnings and Precautions
• Adverse Reactions
• Drug Interactions (Precautions)
• Dosage and Administration
• Overdosage
• Action and Clinical Pharmacology
• Storage and Stability
• Dosage Forms, Composition and Packaging (availability)

Part II: Scientific Information
New Product Monograph Format:
Difference:
Justification for Differences:

• Pharmaceutical Information
• Clinical Trials
• Detailed Pharmacology
• Toxicology
• References

Part III: Consumer Information (Patient Information Sheet)
New Product Monograph Format:
Difference:
Justification for Differences:

Document Compare 2:
Summary of Differences between proposed PM and most recently approved PM:

Part I: Health Professional Information
New Product Monograph Format:
Difference:
Justification for Differences:

• Summary Product Information
• Indications and Clinical Use
• Contraindications
• Warnings and Precautions
• Adverse Reactions
• Drug Interactions (Precautions)
• Dosage and Administration
• Overdosage
• Action and Clinical Pharmacology
• Storage and Stability
• Dosage Forms, Composition and Packaging (availability)

Part II: Scientific Information
New Product Monograph Format:
Difference:
Justification for Differences:

• Pharmaceutical Information
• Clinical Trials
• Detailed Pharmacology
• Toxicology
• References

Part III: Consumer Information (Patient Information Sheet)
New Product Monograph Format:
Difference:
Justification for Differences: