Foreign Review Attestation

Complete parts 1, 2, and 7 for all products and parts 3, 4, 5, and 6 as applicable. Delete parts that are not applicable.

Part 1 - Canadian Product Information

Brand or Proprietary or Product Name (should be the same as the brand name on the product label):
Marketing Authorization Holder Name:
Application / Submission / Data Package Type:
Filing Date:

Part 2 - Foreign Product Information

European Medicines Agency (EMEA)

European Product Name:
Date of Filing:
1. Data package filed? Yes/No
2. Regulatory decision issued? Yes/No
3. Review provided? If yes, go to part 3 (electronic , paper, none)
4. Is / Are indication(s) for use filed with the foreign regulator identical to that requested in Canada? (Yes, No, Not Applicable)

United States Environmental Protection Agency (EPA)

American Product Name:
Date of Filing:
Data package filed? Yes/No
2. Regulatory decision issued? Yes/No
3. Review provided? If yes, go to part 4 (electronic, paper, none)
4. Is / Are indication(s) for use filed with the foreign regulator identical to that requested in Canada? (Yes, No, Not applicable)

United States Food and Drug Administration (FDA)

American Product Name:
Date of Filing:
1. Data package filed? Yes/No
2. Regulatory decision issued? Yes/No
3. Review provided? If yes, go to part 5 (electronic, paper, none)
4. Is / Are indication(s) for use filed with the foreign regulator identical to that requested in Canada? (Yes, No, Not applicable)

Other (specify):

Other Product Name (specify):
Date of Filing:
1. Data package filed? Yes/No
2. Regulatory decision issued? Yes/No
3. Review provided? If yes, go to part 6 (electronic, paper, none)
4. Is / Are indication(s) for use filed with the foreign regulator identical to that requested in Canada? (Yes, No, Not applicable)

Part 3 - European Medicines Agency Review (Human and Veterinary Drugs)

EMA documents provided (see Appendix I of Guidance Document on The Use of Foreign Reviews by the Health Products and Food Branch):
Differences between EMA and Health Canada data packages:

Part 4 - Environmental Protection Agency (Disinfectants)

EPA documents provided (see Appendix I of Guidance Document on The Use of Foreign Reviews by the Health Products and Food Branch):
Differences between EPA and Health Canada data packages:

Part 5a - Food and Drug Administration (Medical Devices)

FDA documents provided (see Appendix I of Guidance Document on The Use of Foreign Reviews by the Health Products and Food Branch):
Differences between FDA and Health Canada data packages:

Part 5b - Food and Drug Administration (Human Drugs)

FDA documents provided (see Appendix I of Guidance Document on The Use of Foreign Reviews by the Health Products and Food Branch):
Differences between FDA and Health Canada data packages:

Part 5c - Food and Drug Administration (Biologics)

FDA documents provided: See Appendix I of Guidance Document on The Use of Foreign Reviews by the Health Products and Food Branch
Differences between FDA and Health Canada data packages:

Part 5d - Food and Drug Administration (Veterinary Drugs)

FDA documents provided (see Appendix I of Guidance Document on The Use of Foreign Reviews by the Health Products and Food Branch):
Differences between FDA and Health Canada data packages:

Part 6 - Other Regulatory Authority (specify and repeat as necessary)

Other regulatory authority documents provided:
Differences between other regulatory authority and Health Canada data packages:

Part 7 - Signed Attestation

I, the undersigned, certify that

  1. the information and material included in this attestation is accurate and complete;
  2. the foreign review(s) provided is (are) the complete and unaltered review(s) provided to us by the foreign regulator;
  3. all differences between the data packages filed with Health Canada and the foreign regulator(s) (upon which the foreign review(s) and marketing authorization decision(s) was (were) based) have been identified.

Name of Authorized Signing Official:
Signature:
Date:
Title, Company:
Email Address:
Telephone Number:

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