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Drugs and Health Products

Clinical Trials Forms and Template

Phase I-III clinical trials involving natural health products on human subjects must be authorized by Health Canada's Natural Health Products Directorate (NHPD) before commencement of the trial. This process requires the sponsor or a designated representative of the sponsor to submit an application package with detailed information about the proposed trial.

Please use the PDF or Microsoft Word versions to fill the forms out - the HTML format should only be used for viewing the forms. The Natural Health Products Directorate no longer accepts hand-written applications.

Forms

The Natural Health Product Directorate strongly encourages applicants to submit applications and replies to deficiency/information requests by courrier service (when the response is too large to fax) because of its greater reliability. Please note that we do not accept the submission of applications by fax.

Applicants will be required to provide all CTA documents in an acceptable electronic format (CD or USB drive) similar to the Notice of Electronic Specifications for CTAs and CTA-As for Clinical Trial Sponsors.

NHPD encourages applicants to register for a PosteCS account to conduct business electronically with the NHPD as part of the Natural Health Products Online Solution (NHP-OLS). Please note that enrolling as a Trading Partner is not mandatory to submit an electronic submission package; however, it does facilitate corresponding with the NHPD electronically through PosteCS, including the submission of new application packages.

Please send your submissions by courrier service to the Natural Health Product Licensing.