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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):

Is the Canadian Reference Product currently on the Patent Registry and does the Patent apply to your product? [that is (i.e.), Strength, dosage form, indication etc.]

If Yes, Abbreviated New Drug Submissions (ANDS) Control number:

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 labels and packages been updated?

(Please include annotated labels in submission)

If Yes, please provide a justification for revisions:

If labels have been updated, have the required Mock-ups of the inner and outer labels and packages been submitted?

Description of Proposed Labelling Changes

A document compare against the most recent CRP shows that the Product Monograph has been updated in the following way; please select the most appropriate option.
Note: only one option should be selected

1. There are no differences between our proposed PM and the CRP PM other than the product brand name and product specific sections (for exemple: comparative bioavailability summary table(s), pharmaceutical information, storage and stability, non-medicinal ingredients, references). Details are provided in tables below.

2. There are some differences between our proposed PM and the CRP PM, such as; a difference in market authorized dosage forms, dosing and administration, strengths and/or indications, which have been previously approved. These differences are in addition to differences in product brand name and product specific sections. Details are provided in tables below.

3. The proposed PM includes revisions, not previously approved, that are different from the CRP PM Details are provided in tables below.

See Appendix for examples of document compare tables

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>
<Title>
<Company>
<Date>

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

CRP name:
CRP PM Date:
CRP control number:

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

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

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

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

Most recently approved PM date:
Most recently approved PM control number:

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

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

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

Appendix. Examples of document compare tables. These pages should not be included in the submission.

Please note the examples provided below are not all inclusive, it is recognized that these tables will vary by submission.

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

CRP name:
CRP PM date:
CRP control number:

New Product Monograph Format
Differences
Justification for Differences

Part I: Health Professional Information

Part II: Scientific Information

Part III: Consumer Information (Patient Information Sheet) / Patient Medication Information

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

Most recently approved PM date:
Most recently approved PM control number:

New Product Monograph Format
Differences
Justification for Differences

Part I: Health Professional Information

Part II: Scientific Information

Part III: Consumer Information (Patient Information Sheet) / Patient Medication Information

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