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Transcript - Natural Health Products Ingredients Database (NHPID)

Description: Cover page - NHP Online Solution. Natural health products licensing made quick, easy and secure.

Narrator: Hello, and welcome to NHPD's Web video on the Natural Health Products Ingredients Database. This video will provide a general overview of the NHPID 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.

From Health Canada's home page, the NHPID is easily accessible by the following URL: http://www.healthcanada.gc.ca/nhponline. This brings you to the home page for NHPD's Online Solution.

Description: Graphic of the Health Canada web site home page. The user types out the URL mentioned above and then hits Enter. The home page for the Natural Health Products Online Solution is displayed.

Narrator: From here you select 'Natural Health Product Ingredients Database'. This page will provide you with some background information on the NHPID.

Description: Graphic of the hyperlink for the Natural Health Products Ingredients Database being selected. This takes the user to the Natural Health Products Ingredients Database web page.

Narrator: The NHPID was designed to:

• capture and provide access to a scientific repository of approved medicinal and non-medicinal ingredient information as well as NHPD monograph and abbreviated labelling standards;
• to validate content of product licence applications as they are prepared electronically; and
• serve as a reference standard for internal assessment, and for the natural health products industry.

Here you will also find access to the NHP Online System Standard Terminology Guide, which provides additional information on the terminology used in the NHPID.

By clicking on the purple button we will now 'Launch the Ingredients Database.'

Description: Graphic of the Launch the Ingredients Database button being selected. This launches the online Natural Health Products Ingredients Database.

Narrator: This is the main screen for the NHPID.

The NHPID is a database that contains over 12,000 ingredients in total, including component ingredients, medicinal, non-medicinal, homeopathic, and non-NHPs. Many ingredients have dual roles, both MI and NMI, for use in NHPs. Using the NHPID you can verify an ingredient's classification, if it's an NHP or not, and its role, medicinal or non-medicinal. The NHPID also replaces the previous list of approved non-medicinal ingredients. Remember that ingredients found in the NHPID are not approved for safety or efficacy.

The NHPID has more than just ingredients as it contains standard terminology found under the Controlled Vocabulary section. This section is used for dosage forms, routes of administration, non-medicinal ingredient purposes, and recognized test methods, among others.

Description: Graphic scrolling down the page. An arrow points to the Controlled Vocabulary Search section of the Natural Health Products Ingredients Database.

Narrator: As per the Application Management Policy of August 2010, all medicinal and non-medicinal ingredients used in NHPs must be listed as such in the NHPID.

Description: Graphic scrolling back up to the top portion of the online Natural Health Products Ingredients Database.

Narrator: This means that if they are not listed as such in the NHPID, the applicant is responsible for submitting a request to the NHPID to add these ingredients and/or their role to the database prior to submitting. The same principle can be applied to dosage forms, routes of administration and non-medicinal purposes.

Using the information found in the NHPID helps to reduce the number of product licence application refusals, and helps to reduce the time for initial review.

The NHPID is also the gateway to our published Pre-cleared information, or PCI, such as single ingredient and product monographs, abbreviated labelling standards, and other labelling standards.

Description: Graphic scrolling down the page. An arrow points to the Pre-Cleared Information section of the Natural Health Products Ingredients Database.

Narrator: By clicking on the link for the PCI desired, for example Product Monographs, you will be brought to NHPD's Product Monographs, listed alphabetically. From this page you can also easily navigate to other pieces of PCI by selecting the tab at the top. Clicking on the name will open the monograph.

Description: Graphic of the Product Monographs hyperlink being selected in the Pre-Cleared Information section of the Natural Health Products Ingredients Database. This takes the user to the Product Monographs tab of the Pre-Cleared Information web page. The screen scrolls down the page. A list of Product Monographs is displayed, organized in alphabetical order. An arrow points to the tab section at the top of the page. The Single Ingredient Monographs tab is then selected, displaying a list of Single Ingredient Monographs in alphabetical order. The hyperlink for Alfalfa is selected. This opens the Alfalfa monograph.

Narrator: At any place in the NHPID, you can go back to the homescreen by selecting the link at the top.

Description: Graphic of the breadcrumb link at the very top of the page being selected. This takes the user back to the Natural Health Products Ingredients Database home page.

Narrator: To search for ingredients, type the name of the ingredient in the Search For field. You can select from the drop-down list a role to further define your search results.

Description: Graphic of arrow pointing to the Search For box. The drop-down list under the Role box is displayed and then closed.

Narrator: Wild cards can also be used, an asterix '*' or percent '%' act as placeholders, while quotations will search for an exact match. Please note that queries are not case sensitive, however they are sensitive to spelling and accents, which is important when searching in French.

For example, if we search for Calcium, without specifying a role, we get almost 180 results. If we want to limit to medicinal, we can now change the role to medicinal and select Search, our results are narrowed down to 24 ingredients. If we now include quotations, we get our exact match.

Description: The term calcium is entered in the Search For box and the Search button is selected. The screen displays the search results. The role is then changed to medicinal and the Search button is selected. This narrows the search results. Quotations are added to the term calcium and the Search button is selected. The search result displays one result.

Narrator:

You can see here that when

PCI

is available for an ingredient, it will appear in the Search results screen. This is so that you know when a monograph or abbreviated labelling standard exists for an ingredient.

Description: Graphic of arrow pointing to the Pre-Cleared Information section of the ingredient search result page.

Narrator:

By clicking on the ingredient name you are brought to the ingredient entry. The top portion displays basic information, such as the proper name, common name, the category of ingredient, if there are any

PCI

available. Scrolling down the entry you will find the information on the ingredient's role.

Description: Graphic of the Calcium hyperlink being selected. This takes the user to the ingredient entry. An arrow points to each field mentioned above. The screen then scrolls back up to the beginning of the ingredient entry page.

Narrator:

The ingredient entry information will differ based on the ingredient type. For example, if we search for a herbal ingredient, such as echinacea, and select the ingredient, the ingredient entry has additional information, such as the preparations and source material. By clicking on the source material, we can see that there are different constituents, as well we can see the taxonomical synonyms. By clicking on the constituents, we can see the various sub-ingredients that have been identified. This is important to know as it directly relates to how information can be entered in the electronic

PLA

.

Description: Graphic of the breadcrumb link at the very top of the page being selected. This takes the user back to the Natural Health Products Ingredients Database home page. The term Echinacea is entered in the 'Search For' box and the Search button is selected. The screen displays the search results. The Echinacea angustifolia hyperlink is selected. This takes the user to the ingredient entry, displaying information on the Defined Organism Substance. An arrow points to the Preparations and the Source Material(s) fields. The Source Material(s) hyperlink is selected. This displays results on the Organism, including information on Source Material Constituent(s) and Taxonomical Synonyms. In the Source Material Constituent(s) section, the Flower hyperlink is then selected. This displays sub-ingredients that have been identified.

Narrator:

Now, going back to the

NHPID

main page, we will take a look at the Controlled Vocabulary section. You can search here for controlled vocabulary the same way as searching for ingredients. Here though you must specify a category. If you wish to see a full list of all dosage forms, simply select the category as dosage forms and click on Search. You can see now that there are over 100 dosage forms

NHPD

considers acceptable, with any identified synonyms and a brief description of the dosage form.

Description: Graphic of the breadcrumb link at the very top of the page being selected. This takes the user back to the Natural Health Products Ingredients Database home page. The screen scrolls down to the Controlled Vocabulary Search section. The drop-down list under the Category box is displayed. The user selects Dosage Forms from the list and the Search button is selected. The screen displays the search results.

Narrator:

Another helpful search category is Test Methods.

NHPD

has 400 recognized test methods. These test methods are considered acceptable when used for quality testing of a natural health product and are directly related to the Finished Product Specification template.

Description: From the drop-down list under the Category box, the user selects Test Methods and the Search button is selected. The screen displays the search results.

Narrator:

Back to the

NHPID

main page, there is also a What's New section. Clicking on this button will give you a list of all updates that have been made to the

NHPID

since the last update cycle. The update cycles approximately every 2 weeks and any new, revised or removed information can be found here. Additionally, each What's New is archived for easy access. It is recommended that applicants check the What's New section when waiting for particular updates or requests made.

Description: Graphic of the breadcrumb link at the very top of the page being selected. This takes the user back to the Natural Health Products Ingredients Database home page. An arrow points to the What's New button in the top right hand corner of the screen. The What's New button is selected. The screen displays a list of all updates that have been made to the NHPID since the last update cycle. The hyperlink for Previous What's New is selected. The screen displays a list of archived What's New pages.

Narrator:

As mentioned previously, changes to the

NHPID

may be requested through an Issue Form, which is available at the bottom of the

NHPID

main page. For more information on submitting requests to the

NHPID

, please refer to the Web video on the

NHPID

Issue Form and the associated guides.

Description: Graphic of the breadcrumb link at the very top of the page being selected. This takes the user back to the Natural Health Products Ingredients Database home page. The screen scrolls down to the bottom of the NHPID home page. An arrow points to the link for the NHPID Issue Form. The screen scrolls back up to the top of the page.

Narrator: For further information on the NHPID, you may contact ingredient support, a submission coordination, or the PLA info email account.

Thank you very much.

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