Human Cells, Tissues And Organs (CTO) For Transplantation Registration Application Form (FRM-0171)

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Our Mandate:
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

  • Supersedes: June 27, 2007
  • Date issued: April 11, 2011
  • Date of implementation: April 11, 2011

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Information

Please refer to the "Guidance Document for Cell, Tissue and Organ Establishments" for instructions on completing this form.

Please send completed Registration Form to:

Health Products and Food Branch Inspectorate
Establishment Licence Unit
250 Lanark Avenue
Address Locator: 2002A
Ottawa, ON K1A 0K9
Fax: 613-957-4147

Part 1 - Reason for Application

  • Initial Registration
  • Change of Information
  • Registration Renewal
  • Current Health Canada Registration Number if available:
  • For New Establishments: Date to begin processing, distributing and/or importing CTO:
  • For Active Establishments: Date began processing, distributing and/or importing CTO:

For importer or distributor, specify name and Current Health Canada Registration Number of source establishment(s)

Use an additional page if required.

Part 2 - Establishment Information

  • Name of Establishment:
  • Previous Name of Establishment (if applicable):
  • Source Establishment  Importer Distributor

Civic Address

  • Street
  • City
  • Province/State
  • Postal /Zip Code:
  • Country:

Postal Address (same as Civic Address)

  • Street
  • City
  • Province/State
  • Postal /Zip Code:
  • Country:

Contact Person for this Establishment

  • Name:
  • Title:
  • Telephone:
  • Fax:
  • Email:

Part 3 - Statement of Compliance

I hereby certify that the establishment named in this application is in compliance with the Safety of Human Cells, Tissues and Organs for Transplantation Regulations.

  • Medical / Scientific Director:
  • Name:
  • Title:
  • Signature:
  • Date:
  • Correspondence preference:
    • Surface mail
    • Fax
    • Email
  • Language preference for correspondence
    • English
    • French

Part 4 - Activity and CTO Information Deceased Donors

Activity for Organs (Heart, Kidney, Liver, Lung, Gastrointestinal, Pancreas)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Activity for Tissues (Bone, Cartilage, Tendon, Skin, Fascia, Veins, Arteries, Pericardium)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Activity for Ocular Tissues (Aortic/Pulmonary Conduits, Cornea, Scelera, Whole globes)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Activity Other (please specify: for examples A: islet cells, B, C or D)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Part 4 - Activity and CTO Information Live Donors

Activity for Organs (Kidney, Liver, Lung, Pancreas)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Activity for Tissues (Bone)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Activity for Lympho-hematopoetic Cells (from Peripheral Blood, From Bone Marrow, from Cord Blood)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Activity Other (please specify: for examples A: islet cells, B, C or D)

  • Donor Screening
  • Donor Testing
  • Donor Suitability Assessment
  • Retrieval
  • Testing and measurements performed on the cells, tissues or organs after they are retrieved
  • Preparation for use in transplantation
  • Preservation
  • Quarantine
  • Banking
  • Labelling and Packaging
  • Import
  • Distribute
  • Storage

Part 4A - Additional Activity Information

Description of Activities performed:

Part 4B - Additional CTO Information (check if not applicable)

Proprietary name

CTO

Part 5 - Other Entity Information (check if not applicable)

Business Name, Address and Contact Person

  • Business Name:
  • Business Address:
  • Contact Name:
    • Title:
    • Telephone:
    • Fax:
    • Email:

Activity Other Entity Performs on behalf of your Establishment

CTO

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