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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:
Note:
Have inner and/or outer package labels been updated?
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:
Part II: Scientific Information
New Product Monograph Format:
Difference:
Justification for Differences:
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:
Part II: Scientific Information
New Product Monograph Format:
Difference:
Justification for Differences:
Part III: Consumer Information (Patient Information Sheet)
New Product Monograph Format:
Difference:
Justification for Differences: