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Transcript - Finished Product Specifications Form

Description: Cover page - NHPD - Natural Health Products Directorate.

Narrator: Hello, and welcome to NHPD's Web video on the Finished Product Specification template. This video will provide a general overview of the FPS and how to use it when preparing for a natural health product licence application. This Web video is not meant to provide complete instructions, but to provide an introduction to the tool; it is recommended to read all associated user guides and guidance documents, and attend other webinars and workshops offered by NHPD.

Description: Graphic of the Finished Product Specifications Form.

Narrator: The Finished Product Specifications Form is a form developed by the Natural Health Products Directorate to help applicants meet the requirements of paragraph 5 (i) of the Natural Health Products Regulations, under which a copy of the specifications to which the natural health product will comply must be provided with each application for a product licence, as well as the quality requirements set out in section 44 of the Natural Health Products Regulations. Use of the form makes it possible to ensure uniform presentation of all the data pertaining to the quality of the natural health product, which speeds up the quality assessment process and reduces the number of Information Request Notices issued. The specifications form and its associated user guide are available online through the NHPD web site.

The FPS form is presented in the form of a table containing all the information needed for assessment of the quality of the product, such as the quantity, the identity and the general and specific test parameters.

Description: Graphic of arrow pointing to each section mentioned above.

Narrator: Only a few exceptions are not covered by the form and may be added in the spaces provided for that purpose.

Description: Graphic scrolling down to Section 2 - Finished Product Specifications Form - Ingredient specific parameters. An arrow points to the 'Other (must specify)' box. Screen scrolls up to the beginning of Section 2.

Narrator: The form was developed using an attestation format, rather than a fixed format in which all the tests must be described in detail; this reduces the amount of work that has to be done to complete the form. When the applicant carries out the recommended or mandatory tests using a NHPD recognized test method and a NHPD approved tolerance limit, the applicant can attest to meeting NHPD's requirements by selecting the appropriate box.

Description: Graphic of arrow pointing to the Yes box under the column 'Test methods meet those set out in the List of NHPD Recognized Methods (if No, provide test method in Section E)'.

Narrator: When a test is done using a NHPD recognized test method and tolerance limit, it is not necessary to submit a certificate of analysis for this test; this reduces the quantity of documents that have to be submitted in connection with the application.

To determine which analysis methods are recognized by NHPD and to obtain more information on the tolerance limits, it is necessary to consult the Natural Health Products Ingredients Database and the Finished Product Specifications Form User Guide.

Description: Graphic of the online Natural Health Products Ingredients Database.

Narrator: The Natural Health Products Ingredients Database is available on the NHPD web site. The test methods are available in the "Controlled Vocabulary Search" section, in the "Test Methods" category. From this location, it is possible to do a search covering the name, type, subtype, restriction and description sections.

Description: Graphic scrolling down to the Controlled Vocabulary Search section of the Natural Health Products Ingredients Database. The drop-down list under the Category box is displayed. A selection is made and the Search button is selected. The screen displays the search results.

Narrator: For example, a search using the term "microbial" yields the following results.

Description: The term microbial is entered in the 'Search For' box and the Search button is selected. The screen displays the search results.

Narrator: When the test method used for the product is in the Natural Health Products Ingredients Database, the applicant can attest to using a NHPD recognized test method on the Finished Product Specifications form. Note that no test method is suitable for all products. By choosing one of the test methods found in the database, you are indicating that you use that test method or a validated equivalent in-house method, and that the test method is suitable for the analysis of your product or raw material. As an example, the limits of this test method are highlighted here.

Description: Graphic of arrow pointing to the limits of a test method.

Narrator: The User Guide and the form are available in the Guidance Document section of the web site.

Description: Graphic showing the Guidance Document section of the Health Canada web site.

Narrator: The acceptable tolerance limits are available in the User Guide. If the limits used for the product fall within the tolerance limits set out in the User Guide, you can attest to meeting NHPD's acceptable limits on the FPS form.

Description: Graphic showing the Finished Product Specifications Form User Guide on the Health Canada web site. The PDF icon is selected. This opens the PDF version of the User Guide. The screen scrolls down to Appendix 2: Acceptable Tolerance Limits for Quality Test Parameters. The screen then displays Section 2 - Finished Product Specifications Form - Ingredient specific parameters.

Narrator: In cases where, for specific reasons, a test does not apply, a test method used is not an NHPD recognized method or a tolerance limit does not reflect the tolerance limits indicated in the User Guide, the applicant must provide a justification in sections E, F or G, depending on the situation.

Description: Graphic scrolling down the form. Sections E, F and G are highlighted.

Narrator: Therefore, when necessary, other documents, for example, certificates of analysis or production documents, may or must be submitted, as the case may be.

The form must be signed before it is submitted.

Description: Graphic scrolling down to the bottom of the form and displaying the Signature Block.

Narrator: If you have any questions about the Finished Product Specifications Form, answers may be found in the Finished Product Specifications Form User Guide or the Evidence for Quality of Finished Natural Health Products" guidance documents available on the NHPD web site.

For further information please send an email to the PLA info email account, or to a submission coordinator.

Thank you.

For more information please visit: www.healthcanada.gc.ca/nhp
or email: pla.info.dlmm@hc-sc.gc.ca