Service standard for the issuance of a risk group 2 Pathogen and Toxin Licence under the Human Pathogens and Toxins Act
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Service description
In Canada, individuals are required to apply for a licence under the Human Pathogens and Toxins Act (HPTA) to conduct controlled activities (possessing, handling, using, producing, storing, permitting any person access, transferring, importing, exporting, releasing, abandoning, disposing of a human pathogen or toxin), unless they are excluded or exempted.
Those requiring a Risk Group 2 Pathogen and Toxin Licence should follow the instructions outlined on the Public Health Agency of Canada's (PHAC) Licensing Program webpage.
Additional information on the HPTA exclusions and Human Pathogens and Toxins Regulations (HPTR) exemptions can be found on the Human Pathogens and Toxins Act web page.
Additional information on Roles and Responsibilities of Individuals Associated to a Pathogen and Toxin Licence is available to help organizations better understand the implications of holding a licence.
PHAC publishes service standards and performance information for high-volume regulatory authorizations, such as licences, which includes this service for licensing program applicants.
Service standard
Our standard is to issue a final decision for a Risk Group 2 Pathogen and Toxin Licence within 80 business days of receiving a complete application that does not require PHAC to seek additional information from the applicant.
Processing times may be longer for incomplete applications, applications that require additional information to be provided to PHAC, or those related to emerging pathogens or any pathogens with unknown risk group classifications.
Performance target
We aim to meet our service standard for at least 80% of Risk Group 2 Pathogen and Toxin Licence applications submitted to PHAC.
Performance results in fiscal year 2023-2024
The service standard for issuing a final decision for a Risk Group 2 Pathogen and Toxin Licence was met 99% of the time.
Service feedback
PHAC is committed to excellence in its processes and practices, and strives to continually improve its interactions with regulated parties. The Agency has therefore established a multi-step approach to efficiently receive, track, analyze, and respond, to address issues in the following sequence:
- Receipt of a formal request or feedback in writing to the Centre for Biosecurity by email at pathogens.pathogenes@phac-aspc.gc.ca
- Creation of file - An Agency representative assigns a file number to the request and establishes an anticipated resolution date.
- Information gathering - After the file is reviewed, the Agency representative may request follow-up information from the correspondent via email or telephone.
- Action redress - Following established processes, the Agency representative carries out all necessary steps to achieve a decision on the redress request.
- Final resolution - The Agency representative informs the correspondent of the organization's final decision regarding the redress request.
Departmental contact
Centre for Biosecurity
Regulatory, Operations and Emergency Management Branch
Public Health Agency of Canada
Telephone: 613-957-1779
Email: pathogens.pathogenes@phac-aspc.gc.ca