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.]

  • Yes
  • No

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:

  • Non-annotated Product Monograph (PM)
  • The second language translation of the Product Monograph (PM)
  • The Mock-up Labels and Packages Certification Form
  • Annotated PM against most recent Canadian Reference Product (CRP) PM (CRP Name dated: MM/DD/YYYY)
  • Note: Please complete Table 1 with the differences between your proposed PM and the CRP PM
  • Annotated PM against most recently approved PM for this product (Product Name dated: MM/DD/YYYY)
  • Note: Please complete Table 2 with the differences between your proposed PM and your currently approved PM.

Note:

  • The annotated PMs should highlight the changes between the current proposed PM and the comparators identified above, and be provided as separate documents.
  • The changes identified in the annotated PMs must be summarised in the Document Compare Tables 1 and 2 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 labels and packages been updated?

  • Yes
  • No

(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?

  • No
  • Yes

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:

  • 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:
Differences:
Justification for Differences:

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

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:

  • 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:
Differences:
Justification for Differences:

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

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

  • Summary Product Information
  • Non-medicinal ingredients (NMIs)
  • First inclusion or changes to the NMIs
  • Indications and Clinical Use
  • Not all indications present, dosage forms and/or strengths are included
  • Indications, dosage and strengths are not all approved for this product
  • Contraindications
  • No Changes
  • Warnings and Precautions
  • No Changes
  • Adverse Reactions
  • No Changes
  • Drug Interactions (Precautions)
  • No Changes
  • Dosage and Administration
  • No Changes
  • Overdosage
  • No Changes
  • Action and Clinical Pharmacology
  • No Changes
  • Storage and Stability
  • Differences in storage conditions
  • Product specific
  • Dosage Forms, Composition and Packaging (availability)
  • Composition and packaging differences
  • Product specific

Part II: Scientific Information

  • Pharmaceutical Information
  • Differences in chemical name
  • Product specific
  • Clinical Trials
  • Comparative Bioavailability Studies
  • Product Specific
  • Detailed Pharmacology
  • No Changes
  • Toxicology
  • No Changes
  • References
  • Updated CRP References
  • Product Specific

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

  • Different non medicinal ingredients, dosage forms and storage conditions
  • Product Specific

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

  • Summary Product Information
  • No Changes
  • Indications and Clinical Use
  • No Changes
  • Contraindications
  • Updates to Contraindications (brief summary to be included) That is (i.e.) Contraindicated in breastfeeding or nursing women
  • Changes are made to match the CRP
  • Warnings and Precautions
  • Updates to Warnings and Precautions (brief summary to be included) i.e., Additional Warning added for hypertension
  • Changes are made to match the CRP
  • Adverse Reactions
  • Updates to Adverse Reactions (brief summary to be included) i.e., Additional Adverse Reaction added to include rash
  • Changes are made to match the CRP
  • Drug Interactions (Precautions)
  • Updates to Drug Interactions (brief summary to be included) i.e., New Drug Interaction with metformin
  • Changes are made to match the CRP
  • Dosage and Administration
  • No Changes
  • Overdosage
  • No Changes
  • Action and Clinical Pharmacology
  • No Changes
  • Storage and Stability
  • No Changes
  • Dosage Forms, Composition and Packaging (Availability)
  • No Changes

Part II: Scientific Information

  • Pharmaceutical Information
  • No Changes
  • Clinical Trials
  • No Changes
  • Detailed Pharmacology
  • No Changes
  • Toxicology
  • No Changes
  • References
  • Updated the CRP Reference
  • Product Specific

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

  • Changed "about this medication", "warnings and precautions", "interactions with this medication", "proper use of this medication", reporting suspected side effects" sections and revision date
  • Changes are made to match the CRP

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