INSTRUCTIONS FOR PATHOGENS TRANSFER APPLICATION
Due to the nature of the material requested for Import, additional conditions may be identified on the Importation Permit for Risk Group 3 and 4 pathogens, and also for specified Risk Group 2 pathogens and restricted toxins. Importation Permits issued for Risk Group 3 and Risk Group 4 pathogens under the Human Pathogens Importation Regulations (HPIR) contain the additional condition #6. This condition states that “No Human Pathogen belonging to Risk Group 3 or 4 may be removed to another location, or transferred into the possession of a person other than the importer, without the permission of the director [of the Pathogen Regulation Directorate, Public Health Agency of Canada]”. Similarly, due to the nature of the material requested for import, Importation Permits issued for selected Risk Group 2 pathogens and restricted toxins under the HPIR contain the additional condition #9. This condition states that “No imported material may be removed to another location, or transferred into the possession of a person other than the importer, without the permission of the director [of the Pathogen Regulation Directorate, Public Health Agency of Canada]”.
Transfer Letters are issued by the Pathogen Regulation Directorate (PRD), Public Health Agency of Canada (PHAC), after review of a completed Transfer Application form.
- Transfer Application forms may be handwritten or typed. Handwritten forms must be legible. If more space is needed for a block, additional information may be attached on a separate sheet.
- The recipient person should be (1) knowledgeable and skilled in the handling of the infectious substance or biological material, (2) be directly responsible for work with the infectious material, (3) should be located at the address within Canada where work with the infectious material will be performed, and (4) be compliant with HPIR regulations.
- Each field on the Transfer Application form must be completed.
- Work objectives, proposed plan of work and additional pertinent information must be provided (i.e. is the work intended for diagnostic purposes, will the pathogen be cultured, is the work in vitro or in vivo , etc.)
- In order for a Transfer Application to be approved, the recipient information provided in the Transfer Application form must be the same as the information present on the recipient’s Compliance Letter (for selected Risk Group 2 pathogens), or on the Certification Letter (for Risk Group 3 or 4 pathogens).
- If the recipient laboratory holds a valid PHAC Compliance Letter, the completion and submission of a new Containment Level 2 (CL2) Checklist is not required. The information provided in the Transfer Request form is sufficient for PRD to process the request. Please attach a copy of the recipient’s Compliance Letter with the Transfer Application form or indicate the Compliance Letter number.
- If the recipient laboratory does not hold a valid PHAC Compliance Letter, a CL2 Checklist must be submitted to our office.
- Ideally, the recipient CL2 Checklist can be submitted with the Transfer Application form , or
- The recipient laboratory can choose to independently submit a CL2 Checklist directly to our office. In this case, a cover letter explaining that a Compliance Letter has been requested in order to receive a Transfer Letter must accompany the CL2 Checklist. The cover letter should contain the name of the transferring lab (Permit Holder and entity name). Without such information, PRD will be unable to identify that the submitted CL2 Checklist is linked to a Transfer Request.
- For the Transfer of Risk Group 3 and 4 pathogens, please indicate the ID Number and/or provide a copy of the Certification Letter of the recipient facility.
- Both the Permit Holder and the recipient person must sign and date the Transfer Application form before it is faxed or mailed to PRD. Furthermore, if the recipient facility has a registered Biological Safety Officer (BSO), this individual must also sign and date the Transfer Application.
- Upon receipt of a Transfer Application form, and subsequent to its satisfactory assessment, a Transfer Letter will be issued to the Permit Holder. It is the responsibility of the Permit Holder to send a copy of the Transfer Letter to the recipient person.
- In you apply for a subsequent transfer, please indicate the Transfer Letter number instead of the permit number.
- Transfer Application and/or CL2 Checklists must be submitted by fax or mail to the Pathogen Regulation Directorate, Public Health Agency of Canada, 100 Colonnade Road, Loc.: 6201A, Ottawa, Ontario, K1A 0K9.Tel.: (613) 957-1779 Fax.: (613) 941-0596.
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Transfer Application Form
PERMIT HOLDER:Permit Number: / P-
Permit Holder Name:
Entity Name:
Department (if any):
Address:
City: / Province:
Postal Code:
Phone: / Fax:
Email address:
Description of material to be transferred:
RECEPIENT LABORATORY:
Recipient Name:
Entity Name:
Department (if any):
Address:
City: / Province:
Postal Code:
Phone: / Fax:
Email address:
Room number(s)/name(s) where material will be used or stored:
Work Objectives, Plan of Work:
In vitro, In vivo, Diagnostic, Culture, Recombinant DNA Technologies.
Does the recipient laboratory hold a valid PHAC CL2 Compliance Letter Or Certification Letter? / Yes No
If "Yes" attach a copy of the Compliance Letter or provide the Compliance Letter number C-______; or ID number or a copy of the Certification Letter.
If "No" answer question below
Is a completed CL2 Checklist attached to this request or is Certification in progress? / Yes No
Permit Holder Signature and date / Biological Safety Officer (BSO) and date / Recipient Signature and date
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