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

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 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.

Please send your submissions by courrier service to the Submission Management Division:

Natural Health Products Directorate
Submission Management Division
Qualicum Tower A
2936 Baseline Rd.
Ottawa, Ontario
K2H 1B3

Questions regarding submissions should be emailed to: nhpd_dpsn@hc-sc.gc.ca