Submission Timelines for Document Review Requests

Under the Human Pathogens and Toxins Act and its associated Regulations, regulated parties are required to notify the Minister and submit documentation to the Public Health Agency of Canada (the Agency) before beginning work in certain situations. This requirement applies to instances such as:

• Initiating unique projects involving regulated materials that fall outside the conditions of the existing Pathogen and Toxin Licence and,
• Making any changes related to Risk Group 3 or 4 work that could impact biocontainment, including modifications to the facility’s physical structure, equipment or to the standard operating procedures.

To avoid delays, submit your documents for review (e.g. local risk assessments or renovation plans) well in advance of your project start date. Reviews may take up to 40 business days*. Early submission ensures the Centre for Biosecurity can fully review the submitted documents, consult if needed, and provide necessary feedback before your work begins.

*The anticipated review time listed by the Agency is approximate and may be affected significantly by the circumstances of each submission, for example, where additional information may be requested by assessors or if all required documentation is not submitted at once.

Following this timeline will help maintain a smooth and efficient review process, which ultimately benefits everyone by preventing any potential delays or issues.

Should you have any questions or require further clarification, please do not hesitate to contact us at biosafety.biosecurite@phac-aspc.gc.ca.