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Drugs and Health Products

Label Safety Assessment Update - Sponsor Attestation

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Brand (Proprietary) Name of Drug Product:

Drug Substance / Medicinal Ingredient:

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 provided:

  • Non-annotated Product Monograph (PM)
  • Annotated PM against most recent Canadian Reference Product (CRP) PM (CRP Name dated: MM/DD/YYYY)
  • Annotated PM against most recently approved PM for this product (Product Name dated: MM/DD/YYYY)

Note:

  • The annotated PMs should highlight the changes between the current proposed PM and the comparators identified above, and be provided as stand-alone documents.
  • The changes identified in the annotated PMs must be summarised in the tables below.
  • All changes must have a justification (for example, update as per the reference product, not approved for this dosage form, level 3 change, type, etc.)

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 (CRP) PM:

CRP name:
CRP PM date:

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:

Most recently approved PM date:

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: