Summary Report Template

FOR VIEWING PURPOSES ONLY - Licence applicants must use the available WORD or PDF versions of this form when submitting it to the Natural Health Products Directorate (NHPD).

General Guidance

Applicants are encouraged to devote sufficient time necessary to prepare a clear and precise Summary Reports. The filling of an inaccurate or an incomplete Report will result in greater expenditure of NHPD's time in reviewing the submission.

The NHPD will ensure that all information provided in the summary reports will be protected.

It is expected that additional space will be required and the applicant may add pages, for the relevant sections, as required. Nonetheless, the titles/parameters listed in the default tables must be retained. The applicant must provide some of the information directly in the space provided in certain areas of the template and for other areas, additional pages must be attached directly following the relevant section.

The applicant must print clearly or type and must refer to the relevant sections in Chapter 9.1 (Evidence Summary Report), Chapter 9.2 (Safety Summary Report), Chapter 9.3 (Combination Rationale), Chapter 9.4 (Non-Medicinal Ingredient Information, if applicable), and Chapter 9.5 (References)of the Evidence for Safety and Efficacy of Finished Natural Health Products guidance document in order to successfully complete the reports. The relevant sections/chapters are also provided within the template to aid the applicant. The applicant should refer to those sections/chapters for further clarification on how to fill that particular section.

The applicant must complete all relevant sections and indicate "not applicable" in sections that are irrelevant for a particular type of submission.

Please refer to the relevant chapters for instructions on how to complete the templates.

Please Print Clearly or Type.

1. Evidence Summary Report (see Chapter 9.1)

1.1 Recommended use or purpose (health claim):

1.2 Critical Overview:

1.3 Dosage and other Conditions of Use:

2. Safety Summary Report (see Chapter 9.2)

2.1 Safety Overview:

2.2 Risk Informationand Risk Mitigation:

3. Combination Rationale, if applicable (see Chapter 9.3)

4. Non-Medicinal Ingredient Information, if applicable (see Chapter 9.4)

5. References (see Chapter 9.5)