Completing the "Application for Permit to Import Human Pathogen(s)"

PDF Version
(Revised: April 2007)

Introduction

Importation permits are issued by the Office of Laboratory Security, Public Health Agency of Canada, after review of a completed application form. Completed application forms may be returned to the Pathogen Regulation Directorate by mail or fax. If the application is submitted by fax, please forward the original signed application by mail.

Application forms may be handwritten or typed. Handwritten forms must be readable. Unreadable forms or incomplete information will delay permit issuance. If more space is needed for a block, you may attach additional information providing the block number(s) you describe is(are) noted on the extra page(s).

Instruction

Block 1. The person requesting the permit (applicant) 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, and (3) should be located at the address within Canada where work with the infectious material will be performed. Regulatory affairs or other general administrative personnel are generally not acceptable as applicants. Enter your complete name and address. The name appearing in this block, and in Block 11 should be the same. One or more names may be used here, however for each name used in Block 1, there must be a corresponding signature in Block 11.

Block 2. Enter complete name and address of the sender.

Block 3. Complete as indicated, noting the following:

• If you are ordering from ATCC, please provide the name and catalogue number.
• If this is the first time ordering a specific product from a commercial supplier other than ATCC, please provide the catalogue number and other relevant descriptive information.
• If the product is coming from a researcher, please provide background product information (references, etc.).

Block 4, 5, 6. Complete as indicated.

Block 7. Describe (briefly) the containment level of the laboratory where the work will occur and include any other information pertinent to your facilities. Please note that we require a completed CL2 checklist (http://www.phac-aspc.gc.ca/ols-bsl/containment/pdf/cl2-checklist_e.doc) if it is the first time that application for a permit is being made, or if there are changes to your laboratory address since your last application. Failure to provide this information could cause unnecessary delays in the processing of the application.

Block 8.Complete as indicated. For importation of Risk Group 3 or 4 material, please include the actual room number (and also the building name/number if applicable) where the imported human pathogen will be used.  In order to facilitate correspondence and documentation exchange, please include the ID# that was previously assigned to your facility.

Block 9. Complete as indicated.

Block 10. In describing work objectives, please state the intended use(s): in vitro or in vivo (include animal model) activities, infectious disease research or diagnosis, genetic studies or analysis, chemical or biochemical analysis, enzyme assays, population profiles, kit development, etc.
NOTE: If you are importing samples containing HIV, HTLV or Mycobacterium tuberculosis, please indicate if these organisms will be cultured. Failure to provide this information will cause unnecessary delays in the processing of the application.

Block 11. Remember to sign the form before it is faxed or mailed. The signature should be that of the person requesting the permit. Applications cannot be processed if the containment level is not indicated.

When completed, please forward the original application to:

Pathogen Regulation Directorate
Centre for Emergency Preparedness and Response
Public Health Agency of Canada
100 Colonnade Road, Loc.: 6201A
Ottawa, Ontario K1A 0K9

Tel.: (613) 957-1779
Fax.: (613) 941-0596

Upon receipt of your application and its satisfactory assessment, a permit will be issued and faxed to you. Your original permit will follow by regular mail.

If you have any questions regarding this matter, please do not hesitate to contact our office.