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 and Non-prescription Health Products Directorate (NNHPD) 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 and Non-prescription Health Products Directorate no longer accepts hand-written applications.
Forms
- Animal Tissue Form
- Adverse Reaction Report Form for Clinical Trials
- Authorization for a Third Party to Import a Natural Health Product for a Clinical Trial Form
- Clinical Application and Attestation Form
- Clinical Trial Site Information Form
- Protocol Synopsis and Evaluation Review Template
- Quality Overall Summary - Natural Health Products
- Qualified Investigator Undertaking Form
- Research Ethics Board (REB) Attestation Form
The Natural and Non-prescription Health Products 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.
NNHPD encourages applicants to register for a PosteCS account to conduct business electronically with the NNHPD 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 NNHPD electronically through PosteCS, including the submission of new application packages.
Please send your submissions by courrier service to the Natural Health Product Licensing.
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