Natural health product licence application form user guide

1. Natural health product licence application form overview
2. Recommendations for optimal results
   1. General
   2. Form-specific
3. Natural health product licence application form
   1. New application
   2. Load saved application from file
4. Applicant or licensee
5. Contact information
6. Site information
7. Application information
8. Product information
9. Medicinal ingredients
   1. Add medicinal ingredient
   2. Ingredient search: general information
   3. Standard dosage unit information
   4. Medicinal ingredients table
   5. Modify medicinal ingredient
10. Non-medicinal ingredients
    1. Add non-medicinal ingredient
    2. Non-medicinal ingredients table
    3. Modify non-medicinal ingredient
11. Recommended use or purpose
12. Recommended dosage
    1. Recommended dosage table
    2. Modify recommended dosage
13. Duration of use
14. Risk information
15. Animal tissue forms
    1. Animal tissue form table
    2. Modify animal tissue form
16. Label text
17. Summary
    1. Validate compendial application
    2. Attestation
    3. Finalized form
18. Submitting to the NNHPD

The web-based Product Licence Application (web PLA) form is the main component of any natural health product licence submission package. The form is designed to be completed online and saved at any time to your workstation. Through an active internet connection, the web PLA form searches and populates data from the Natural Health Products Ingredients Database (NHPID) and links to the Natural and Non-prescription Health Products Directorate (NNHPD)'s new monograph validation service to performin-form real-time validation of compendial (class I) applications.

For information on the terminology used in the form and the appropriate information to be included in a Natural Health Product (NHP) licence application, please review the Product Licensing Guidance Document. For information on NHP licence application requirements and the submission process for each application type please read the Natural Health Products Management of Applications Policy. For information on quality requirements for natural health products, including Finished Product Specifications (FPS) and product testing such as general purity, please consult the Quality of Natural Health Products Guide and the Good Manufacturing Practices Guidance Document.

Prior to submitting a PLA package, if you are uncertain as to the classification of your product (i.e. whether or not it is a NHP), please consult the product classification section of the Natural Health Products Management of Applications Policy for a list of helpful regulations, guidance, and tools. You will also find instructions on how to submit a product classification request to NNHPD.

To report bugs or request additional information not provided in this help text, please contact Natural health products online support.

Recommendations for optimal results

Following the recommendations below will ensure the best possible outcome when using the web PLA form.

General

Become familiar with the Natural Health Products Ingredients Database

It is highly recommended that you become familiar with the Natural Health Products Ingredients Database (NHPID) and its terminology prior to starting an application to ensure each ingredient is represented correctly on the web PLA form. The web PLA form populates information such as medicinal ingredients, non-medicinal ingredients, and monograph data directly from the NHPID. This feature will ensure consistency in ingredient representation by restricting entries to only what is acceptable as per the NHPID.

Become familiar with monographs

Before selecting a monograph in the web PLA form, be sure to review it online (using the Natural Health Products Ingredients Database) to understand any limitations on ingredient(s) and conditions of use. You may find that another monograph more closely meets your needs or that no monograph supports the specifics of your product.

Note: Class I and Class II applications must comply with all monograph parameters. For more information on what constitutes a Class I, II and III submission please see the Natural Health Products Management of Applications Policy.

Become familiar with the Natural Health Products Management of Applications Policy (MAP)

Before using the web PLA form, it is very important to become familiar with application types (compendial, general, traditional, homeopathic) and classes (class I, II, III) in order to know which are appropriate for your product (see the Natural Health Products Management of Applications Policy). Certain changes, such as changing the Application type on the Application Information page, will result in the loss of any information already captured in subsequent sections of the form. Because the form may not behave as intended, applicants should not go back and change the application type during an active session. A warning box will appear when navigating to another page to notify the user that data-loss will occur. Options will be given to either proceed with or cancel the changes.

Web PLA form

Meet the system requirements and enable JavaScript

While the web PLA form will function in most browsers, for best results, we recommend using either Firefox 54+ or Chrome 60+. The web PLA form also requires you to have JavaScript enabled in your browser. When JavaScript is disabled the form will malfunction, e.g. buttons and text fields will be disabled and the French version will be missing some French text.

Click on enable JavaScript to find the instructions to your browser.

If you have concerns with making these changes to your security settings, consult with your IT security advisor first.

Use the Help link to access the help text while filling out the web PLA form

Every page of the form will have a Help link. Clicking on the link will open the help page corresponding to the section of the form you are on. While on the help page, you can scroll up and down to continue reading, or select index to navigate to a list of all sections of the user guide. To exit the help page and return to the form, you can click anywhere outside the help text or click the Esc (escape) key on your keyboard.

Save your progress — sessions will timeout

The web PLA form can be saved at any time on your workstation and resumed later by loading the HTML back into the form. During an active session, any data you enter in the form is temporarily retained. However, after 29 minutes of inactivity your session will timeout and any unsaved progress will be lost. A timeout warning will pop up 5 minutes before the actual timeout. Clicking on "Continue session" will refresh the timer. If you are unable to continue with your session, please remember to save your progress prior to exiting the application by clicking on "Save file" at the top right corner of the form.

Allow web pages to refresh before continuing

If you begin to make selections and enter information before the web page has fully refreshed, the information will be lost. Depending on your internet speed it might take several seconds for the web page to refresh. To prevent entering the same information twice, allow the web page to refresh before continuing.

Validate as you go

The web PLA is continually applying form validation rules to ensure that the information you enter is as accurate and complete as possible. Where applicable, always select the "Continue" button to validate the content of a page before moving onto the next section.

When the information is incorrect or when a required field is empty, an error message will appear above the page indicating which field has missing or incorrect information. An error message highlighted in red will also display above the field(s) causing the error. You may click on the error message or scroll through the page to access the field(s) to be revised. Be sure to review the entire page and correct each instance before selecting the "Continue" button again. The form will not finalize until these fields are revised.

If the page does not have a continue button, then click the "Next" button to move to the next section of the form.

Note: For all NNHPD forms, required fields are indicated by a red asterisk (*) before the field label and the word "(required)", after the field label.

Create templates

When submitting multiple product licence applications to the NNHPD, it is worth saving templates prior to completing and finalizing the form. For instance, you may save a copy of the form with completed contact information, if this information remains consistent across multiple applications. The same can be done for products that have the same list of non-medicinal ingredients across multiple products. Loading a template rather than starting a new form eliminates repetitious data entry.

Use the form's navigation features

The web PLA has several navigation features that are consistent across the entire form. During an active session, it is highly recommended to use the web PLA's navigation features rather than the browser's forward and back buttons, which can result in unpredictable form behaviour.

Table of contents: The table of contents can be accessed from the top right of the web PLA form. It identifies the main sections of the form and allows you to move between them. Use the table of contents if the form doesn't automatically flow to the next section of the form.

Summary: At any time while completing the web PLA form, select "Summary" at the top right to review your information.

Save file: To save your progress or to create a template, select "Save file" to save a copy of the web PLA form to your local drive. The file will be saved in HTML format. You may be prompted to save the file to a specific location, or the file may save automatically to your default download folder. To reopen and continue working on a saved session, select "Load submission from file" from the web PLA landing page, locate the .html file on your local drive, and select "Load data".

Exit: Selecting "Exit" during a session will bring you back to the web PLA form landing page and erase any data from that current session. Only select this option to start a new form without finalizing/saving the current form, or after saving a copy of the current form to your local workstation.

"Back to" links: Certain pages of the web PLA form, such as "Modify medicinal ingredient", will display a link that navigates back to the table of records instead of the usual previous and next buttons, e.g. "Back to medicinal ingredients table". Use the "Back to" links to return to the corresponding table of records without saving new or modified data on the page. If you wish to save the changes made on that page, select "Continue", which will save the changes and take you to the corresponding table of records.

Natural health product licence application form

New applications

From the landing page, select "New application" to open a new Product licence Application form.

Load application form from file

The "Load application form from file" option allows you to load a previously saved web PLA form back into the web application. Only web PLA files saved in HTML format will load. Depending on whether the web PLA form is finalized or not, different load options will appear.

Note: Files saved using web PLA form version 3 will not load into web PLA form version 4 and vice versa.

Loading a non-finalized application form: Load a non-finalized application form from file (i.e. partially completed forms or templates saved to your local drive) to resume your session online. Once a file has been selected, review the file information (brand name and licensee) to confirm your selection and then click on "View summary" to load the application form into the web application.

Loading a finalized application form: Load a finalized web PLA form from file in order to view it online, modify it in response to an Information Request Notice (IRN), or copy all contact information and start a new application. If a finalized application is loaded, the tracking number will appear in the file information view along with the brand name and applicant/licensee.

When a finalized form has been selected, three actions are possible:

• View summary: Opens the finalized summary page without unlocking the form for editing.
• Modify in response to an IRN*: Opens and unlocks the form for editing. This option is used to revise previously submitted data in response to an Information Request Notice. The tracking number remains the same after the form is modified and re-finalized.
• Copy contacts and start new session: Opens a new form and copies all Applicant/licensee and Contact information from the finalized form into the new form.

*Note: The tracking number must be unique for all new product licence applications submitted to the NNHPD. Since the modify function will retain the original tracking number even after re-finalizing, this function cannot be used to revise an existing form and submit a new application if the original form has previously been submitted.

Applicant or licensee

The Applicant or licensee page captures information about the company that the product licence will be registered to (the applicant will be referred to as the licensee once a licence is issued).

The Company name, Company code, Street, City and Country are required in all cases. If the Country is "Canada" or "United States", the Province/State and the Postal/ZIP Code are also required.

Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number).

Company Code

A company code is the unique five-digit code assigned to an individual company by the NNHPD. On the Applicant/Licensee page, the company code must be the one assigned to the applicant/licensee. The form will not verify that the company code is correct, therefore do not use a third party contact's company code as this will cause a delay in the processing of your submission and may result in the refusal of your application. To obtain a company code, submit a request via hc.nnhpd-dpsnso.sc@canada.ca and indicate "Company code request" in the subject line. In the body of the email, please include the same company contact information you will be using to complete your web PLA form such as company name, address, and senior official contact details.

Contact information

The contacts table includes a section for each required contact person: senior official, application contact, and representative in Canada (if the applicant or licensee is outside of Canada). To input or modify contact information, select the "Modify" button next to the corresponding contact. On the next page, input all required contact information and select the "Continue" button to return to the contact information table. To add a contact, click on "Add application contact". To remove a contact, select the "Remove" button next to the corresponding contact.

Senior Official

The senior official is the principal contact person for the applicant or licensee, at the address given. All regulatory mail including the product licence is sent to this person. This is not the contact person for submission-specific questions, but the person who has the authority to represent the company.

Application contact

The application contact is the person to whom NNHPD will direct product-specific questions. This may be an employee of the applicant or licensee, or an individual contracted from another company on behalf of the applicant or licensee (3^rd party consultant). There may be more than one contact indicated per application. A Designated Party Authorization (DPA) form is required for each application contact person (see the Natural Health Products Management of Applications Policy for further details).

Representative in Canada

The representative in Canada is the person to whom NNHPD will direct regulatory mail. There must only be one representative in Canada indicated per application. A Representative in Canada is only required to be indicated on the PLA form if the applicant or licensee address is outside of Canada.

Site information

If the application is for a non-hypothetical product, then site information is required in order to finalize the application form. Indicate the name and address of each site used in the manufacturing, distribution, labelling, packaging, and if applicable the importation of the Natural Health Product (NHP). If the application is for a hypothetical product, this information will remain optional.

To input site information, select the "Add a site" button. Then, in the Site information table, select modify next to the corresponding site. On the Modify site information page, input the company name, address and associated activity/activities e.g.manufacturer, packager, labeller, distributor, and/or importer. For Canadian sites, provide the site licence number if available. Select the "Continue" button to save the information and return to the site information table. To add a new site, select the "Add site" button. To remove a site, select the "Remove" button in the corresponding row.

Application information

Application type

There are four types of applications:

• Traditional
• General (non-traditional)
• Compendial (including compendial homeopathic)
• Homeopathic (non-compendial)

The type of application selected in the Application Information section determines the layout and behaviour of the web PLA. It is important not to change the application type mid-session in order to avoid loss of data.

Monograph

A monograph selection is required for compendial applications where the entire product must comply with the chosen monograph for safety, efficacy and quality. In order to finalize a form in Compendial, the product must pass monograph validation. Do not select Compendial if your product does not comply 100% with monograph specifications. For all other application types, monograph attestation is optional per medicinal ingredient. Applicants can either add medicinal ingredients without attesting to a monograph (class III only), or attest to a monograph and populate the form with the ingredient(s) from that monograph (class II and III). For each attestation to a monograph, applicants must also indicate why they are attesting, i.e. in support of the safety, efficacy and/or quality of the ingredient(s).

Application class

If the application type is compendial, the form will auto-select class I and disable the other two class options. For all other application types, the class I button will be disabled and you will need to identify the appropriate class for your application.

For more information on application classes, please refer to the Natural Health Products Management of Applications Policy.

Is this formulation hypothetical?

Select either yes or no to indicate whether or not this formulation is hypothetical. If no is selected, the Site information section of the form must be completed.

This application is for a kit

If the application is for a kit, please select the button "This application is for a kit". Kit applications are only accepted via class II or III. If your application is for a kit, the class I button will be disabled and you will need to verify that the appropriate class is selected.

Reference submission

The Reference submission section is fillable for all application types except for Compendial. Where related submissions are referenced, provide the applicant/licensee's company code, the submission number, the file number, and if available, the Natural Product Number (NPN), Drug Identification Number (DIN) or Drug Identification Number for Homeopathic Medicines (DIN-HM). Indicate the summary report(s) being referenced by checking the appropriate box for safety, efficacy, and quality. Where applicable, a letter of access must be enclosed with the submission.

To reference more than one submission, select the "Add reference" button to display another reference field.

For more information on referencing a submission and on letter of access requirements, please refer to the Natural Health Products Management of Applications Policy.

NNHPD master file reference

The NNHPD master file reference section is optional for all application types. Where related submission information is contained in a Master file, please indicate the master file number, the information being supported (such as safety, efficacy, quality, or complete submission), and whether a letter of access is enclosed.

To reference more than one NNHPD master file, select the "Add master file reference" button to display another master file reference field. Master file references can be removed by clicking on the "Remove" button.

For more information on NNHPD master files and letter of access requirements, please refer to the Natural Health Products Management of Applications Policy.

For more information on application requirements and information required to complete the Application information section, please refer to the Product licensing guidance document.

Product information

General information about the product is collected on the Product information page. This includes the primary brand name, other brand name(s), route of administration, dosage form, sterility, and whether or not animal tissue was used in processing.

Primary brand name: This is a free text field. Enter the product's primary brand name.

Other brand name(s): This is a free text field. To add more brand names, click on the "Add brand name" button. To remove a brand name, click on the "Remove" button. Enter only one brand name per field.

For more information on brand name requirements, please refer to the Labelling guidance document.

Route of administration: The route of administration section is populated from the Natural Health Products Ingredients Database. For a compendial application, the route(s) of administration is/are pre-determined by the chosen monograph. For all other application types, a complete list of all routes of administration is provided. Only one route of administration may be selected.

Dosage Form: A drop-down list of dosage forms is generated based on the selected route of administration. Only one dosage form can be identified per product.

Note: Acceptable synonyms for dosage forms can be found in the NHPID; synonyms can be used on the marketed label.

Note: The routes of administration and dosage forms are derived from the International Council for Harmonization (ICH) M5 data elements and standards. Please refer to the Natural health products online system standard terminology guide for further explanation.

Sterile: Indicate whether or not your product is sterile by selecting either "Yes" or "No". For compendial and homeopathic applications, the sterile field is set to "No" and locked, except when the route of administration is Ophthalmic. For all application types, and when the route of administration is "Ophthalmic", the sterile field is set to "Yes" and locked. The application type Traditional or general (non-traditional) should be selected for any other sterile product.

Is animal tissue used in processing?: This question relates to whether or not animal tissue was used directly or indirectly in the processing of the product but not present in the finished product. If yes, select "Yes" and fill out the animal tissue form that will be added to the table; otherwise, select "No".

Kit products

Additional information is required for kit products including the primary and other brand name(s) for the kit, the primary and other brand name(s) of the current product and the brand name(s) and product category for each of the other products in the kit.

Primary brand name – Kit: This is a free text field. Enter the kit's primary brand name.

Other brand name(s) – Kit: This is a free text field. To add more brand names, click on the "Add brand name" button. To remove a brand name, click on the "Remove" button. Enter only one brand name per field.

Primary brand name – Product: This is a free text field. Enter the primary brand name for the product in the current application.

Other brand name – Product: This is a free text field. To add more brand names, click on the "Add brand name" button. To remove a brand name, click on the "Remove" button. Enter only one brand name per field. Only enter alternate brand names for the product in the current application, not the other products in the kit..

Other Kit Products table

The Other kit products table allows you to indicate the name and product category for each of the other product(s) in the kit.

Click on "+ Kit Product" to add a product to the table. This action will take you to the Other Kit Product page where you will be required to enter a primary brand name and product category (natural health product, medical device or cosmetic product) for the other product in the kit. Once the required information has been entered, the information will appear in the Other Kit Products table. Repeat this task to add more products to the table.

Medicinal ingredients

This page enables you to search and select medicinal ingredients, attest to monographs for individual ingredients, identify the standard dosage unit of the product, review medicinal ingredient(s) information, and link to the medicinal ingredient modify page.

Note: Before adding your medicinal ingredient(s) to the form, research the ingredient(s) in the Natural Health Products Ingredients Database to:

• Ensure the ingredient(s) already exists in the NHPID.
• Know which ingredient(s) to select. Some ingredients may appear to be the same but have different constituents, extract information, methods of preparation, or source information.

If the required ingredient information cannot be found in the NHPID, you can submit a formal request to add the information using the Natural Health Products Ingredients Database Issue Form. Please consult the Natural Health Products Ingredients Database issue form user guide for details on its use. Completed NHPID Issue forms must be sent to hc.ingredient.support.sc@canada.ca for review and inclusion in the NHPID.

Add medicinal ingredient

The Add medicinal ingredient section will function differently depending on the application type and when applicable, the type of monograph selected.

Compendial applications: the Add medicinal ingredient section will prepopulate with the monograph selected on the Application Information page. If attesting to a single ingredient monograph, the medicinal ingredient will also prepopulate in this section and automatically be added to the form. If attesting to a product monograph, the Add medicinal ingredient section will prepopulate with a list of medicinal ingredients from that monograph. Use the "Add" button next to an ingredient to add it to the form.

Non-compendial applications: The Add medicinal ingredient section enables you to search and select a monograph for individual ingredient attestations and/or search and select medicinal ingredients to be added to the form.

Monograph attestation

For non-compendial applications, begin by indicating whether you are attesting to a monograph. If "Yes", the monograph field will appear with a drop-down list of monographs filtered based on the product's route of administration. If "No", the Medicinal ingredient search field will appear instead.

Monograph selection

Locate the monograph you are attesting to in the drop-down list and click "Select" to confirm your selection. If you select a single ingredient monograph, the medicinal ingredient will auto populate to the right of the search area with associated attestation parameters (safety, efficacy and quality). If you select a product monograph, a list of medicinal ingredients from that monograph will appear to the right, each with their own associated attestation parameters.

Medicinal ingredient search

The medicinal ingredient search field will appear if you are not attesting to a monograph. To search for a medicinal ingredient, enter the full name of the medicinal ingredient in the Medicinal ingredient search field and select the "Search" button. To further refine your search, indicate the type of ingredient you are searching for prior to clicking on the "Search" button. For detailed definitions of the ingredient types, please refer to the Natural health products online system standard terminology user guide.

Search results will appear on the right beginning with the top match followed by the remaining search results in alphabetical order of NHPID approved name. If many search results are returned, a filter will appear to help narrow the search results even further.

For all homeopathic applications, the search includes only homeopathic ingredients referenced in the following five pharmacopoeias: Homeopathic Pharmacopoeia of the United States (HPUS), Encyclopedia of Homeopathic Pharmacopoeia (EHP), German Homeopathic Pharmacopoeia (HAB), European Pharmacopoeia (PhEur), and Pharmacopée française (PhF).

See Ingredient Search: general Information for more information on conducting an ingredient search and what to do if a search returns with no results.

Adding a medicinal ingredient to the medicinal ingredients table

The medicinal ingredient search results will display to the right of the search area. For non-compendial applications, if you are not attesting to a monograph, select the medicinal ingredient from the search results to add it to the medicinal ingredients table.

If a single ingredient monograph is selected, the ingredient will auto populate to the right of the search area. To add it to the form, indicate whether you are attesting to the monograph for the safety, efficacy and/or quality of that ingredient by checking the corresponding checkbox(es). Click "Add" to add the ingredient to the form. Once added, the "Add medicinal ingredient" section will refresh automatically.

If a product monograph is selected, a list of medicinal ingredients from that monograph will auto populate to the right of the search area. To select an ingredient and add it to the form, indicate whether you are attesting to the monograph for the safety, efficacy and/or quality of that ingredient by checking the corresponding checkbox(es). Once selected, click on the corresponding "Add" button to add the medicinal ingredient to the form. Repeat these steps to add more ingredients from the same monograph. When you are done selecting ingredients, click on "Clear search" to refresh the "Add medicinal ingredient" section and start a new search.

Ingredient search: general information

The search field is designed to search and retrieve data from the NHPID. The following fields are searched:

• NHPIDapproved name;
• Proper names
• Common names
• Synonym

Selecting a filter: The search engine has a default of all ingredient types. If you know the type of the ingredient, you may check the type accordingly. For detailed definitions of the ingredient types, please refer to the Natural health products online system standard terminology user guide. Check "Any" to search all types.

Inputting a keyword: Input simple keywords only. Operators such as "and" and "or" are not applied and may cause the search to be unsuccessful. All information that is entered will be treated as a single word.

Using wildcards: Wildcards are acceptable. Use quotation marks "" to search for an exact match (spelling must also be exact). Use '*' or '%' for zero or more continuous characters and '_' for a single character. Example: if you launch a search with 'green*flavour ' or 'green%flavour ', the results will include 'Green Tea Flavour '. For more details, please review the Natural Health Products Ingredients Database web application guide.

Getting detailed information of an entry: Selecting the hyperlinked medicinal ingredient name shows the detailed information of the ingredient found in the NHPID through the web browser.

When a search fails: The failure of a search does not always mean the specified ingredient is missing from the database. The following situation may contribute to a failed search:

• Spelling errors
• Improperly using wildcards, and/or
• Using a spelling variant that is different from the spelling used in the database.

This may happen in cases where there are different spellings of a term among American, Canadian, and British English, and in cases where there is more than one spelling for a Latin binominal name.

The conclusion of "no ingredients found" can only be reached after performing a sufficient and proper search. If you are experiencing difficulty finding ingredients through the search function of the web PLA, it is best to fully explore the ingredient using the Natural Health Products Ingredients Database.

Note: If any name or term cannot be found from the search tool or from pick lists, the user will need to fill out an NHPID Issue form and send it to the NNHPD to request that the missing information be added to the database (see Natural Health Products Ingredients Database issue form guide). An ingredient must appear in the NHPID with the appropriate ingredient role in order to be added to the web PLA form.

Standard dosage unit information

Standard dosage unit refers to a determinate quantity of product, against which each medicinal ingredient quantity is expressed, e.g. 1 capsule, 5mL, 1 tablespoon, etc. In the web PLA form, all medicinal ingredient quantities must be expressed per standard dosage unit or as percentages, depending on the type of dosage form and dose.

• Discrete dosage forms: For natural health products sold in the form of a tablet, capsule, patch, or other discrete dosage form, the standard dosage unit is one dosage form unit (e.g. one capsule).

  In the web PLA form, when a dosage form is discrete, the Standard dosage unit information section will auto populate with the following message: "For discrete dosage forms, medicinal ingredient quantities must be expressed per 1 [insert dosage form].

• Non-discrete dosage forms - Measured dose: For natural health products in the form of a liquid, powder, or other non-discrete dosage form that are measured prior to administration (measured dose), the standard dosage unit is the measured quantity of product used in a standard single dose e.g. 1 teaspoon, 5 mL, 1 drop, etc.

  In the standard dosage unit information section, select the dose type "Measured dose" to reveal the standard dosage unit fields. Enter the measured quantity of product to be taken in a standard single dose.

• Non-discrete dosage forms - Unmeasured dose: Some natural health products in non-discrete dosage forms such as creams and ointments may not require a measured dose. Instead, an unspecified amount of product is to be administered, e.g. "apply to affected area as needed". When the dose type is unmeasured, there can be no standard dosage unit, therefore the medicinal ingredient quantities must be expressed as percentages.

  In the standard dosage unit information section, select the dose type "Unmeasured dose". On the Modify medicinal ingredient page, the unit of measure will default to percent (%).

Medicinal ingredients table

Medicinal ingredients that have been added to the Medicinal ingredients table will be highlighted and marked as "to be completed". To complete the medicinal ingredient entry, click the "Modify" button corresponding to that ingredient. This action will take you to the Modify medicinal ingredient page. Once the required information has been entered for that ingredient, it will appear in the Medicinal ingredients table and the row will no longer be highlighted. All required MI entries must be complete in order to finalize the form.

Modify medicinal ingredient

For all applications except homeopathic, if you are attesting to a monograph for a particular medicinal ingredient, the data available for selection on the Modify medicinal ingredient page will be restricted to the information found in the corresponding monograph. If you are not attesting to a monograph, the data available for selection will include all available data for that ingredient.

For homeopathic applications, the data available for selection is derived from the homeopathic ingredient information found in the NHPID. All textual information will appear in the original language of the pharmacopoeia, meaning English for all pharmacopoeias, except for ingredients coming from the Pharmacopée française where the information is in French only. This is the only situation where ingredient information may not be consistent with the language chosen on the form.

Proper name: Ingredient's proper name. If there is only one applicable proper name, it will be pre-selected, otherwise select one from the pick list. All proper names are pre-populated from the Natural Health Products Ingredients Database and are based on the Natural health products regulations.

Common name: Ingredient's common name. If there is only one applicable common name, it will be pre-selected, otherwise select one from the pick list. All common names in the pick list are pre-populated from the Natural Health Products Ingredients Database and are derived from authorized references.

Standard or grade: If the ingredient conforms to a particular standard or grade (such as United States Pharmacopoeia, British Pharmacopoeia, etc.), it can be stated here. The pick list of pharmacopoeias presents pharmacopoeial grades acceptable to the NNHPD. The Standard or Grade is required for homeopathic applications

Quantity per standard dosage unit: Amount of the ingredient per standard dosage unit. Numerical values only.

Unit of measure: Unit for the quantity. The most popular units - Grams, Micrograms, Milligrams, Millilitres and Percent - are shown first followed by the other units in alphabetical order.

Additional quantity per dosage unit: Click "Additional quantity per dosage unit" to specify the amount of the ingredient using other units.

Animal tissue used: This field is pre-populated based on simple rules but its content should always be verified. If the ingredient is derived from an animal tissue, or if animal tissue was used in processing the ingredient (such as using natural lactose for trituration), check "Yes" and fill out the animal tissue form that will be appended to the table of contents; otherwise check "No". See also the "Animal tissue forms" section for more information.

Homeopathic potency: Appears for homeopathic applications only. The dilution or potency applied in the product in homeopathic units.

Synthetic: A "Yes" or "No" response is required. Check "Yes" if the ingredient is synthetically derived or ""No" if the ingredient is not synthetically derived.

Is it nanomaterial?: If you are unsure, please consult the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials for more information. A "Yes" or "No" response is required. If the answer is "Yes", the nanomaterial is added to the list of nanomaterial ingredients on the summary page. Please note that nanomaterials are not permitted in the compendial application stream.

Source Information

Source material: If applicable, select the source material (Latin binomial name and organism part) from the drop-down lists provided. If there are many source materials included in the formulation, click the "Add a source material" button.

Source ingredient: If applicable, select the source ingredient from which the ingredient was isolated. Multiple selections can be made. For ingredients having both source ingredients and source material, a selection from at least one of the two fields is required.

Method of preparation: The method used to prepare the ingredient for use in the product is required for organisms and defined organism substances. The method of preparation selection will determine what further source information is required. Detailed information on the NNHPD methods of preparation can be found in the Natural health products online system standard terminology user guide.

For homeopathic applications only: An "Add method of preparation" button is available to enable free text entry of method of preparation.

Potency/sub ingredients:

If the method of preparation is standardized, the Potency/sub ingredients section will appear with all fields marked as required. At least one sub ingredient/constituent potency must be declared.

If the medicinal ingredient is a chemical or protein substance with associated sub ingredients, the potency/sub ingredients section will appear with all fields marked as optional.

• Constituent: Choose the constituent/sub ingredient name from the drop-down list provided. This may be pre-selected depending on the ingredient. Add more constituents by selecting "Add Constituent". If a constituent has been added in error, select "Remove" to remove it from the form.
• Amount: A numeric value is required.
• Unit: Select the correct unit of measure from the picklist.

Extract:

The method of preparation selection will determine whether or not extract information is required to be added to the form. For certain standardized extracts, the extract fields may be removed by selecting "Exclude extract information".

• Original material used: Indicate whether the original material used is dry or fresh. If "Fresh" is selected, then the "Fresh to Dry Ratio" is also required.
• Fresh to dry ratio: When the original material used is fresh, indicate the Fresh to dry ratio as X:1, where x is how many parts of fresh material used to obtain 1 part of dry material.
• Quantity crude equivalent: The quantity of crude material equivalent to the final preparation. Both the quantity and unit of measure are required. A range may also be provided.
• Ratio: Ratio of the quantity (mass) of raw material used to the quantity (mass or volume) of final preparation. The web PLA form will automatically calculate the ratio when the quantity per dosage unit and the quantity crude equivalent are both provided. This field cannot be manually edited. More detailed information can be found in the Natural health products online system standard terminology user guide.

Solvents:

The method of preparation selection will determine whether or not solvent information is required to be added to the form.

• Solvent name: The solvent used for the preparation must be chosen from the drop-down list provided. To add more solvents, click on the "Add Solvent" button.

  Note: If the solvent appears in the finished product, it must also be indicated in the Non-medicinal ingredient section of the web PLA.

• Solvent strength (%): A numeric value representing the solvent strength in percentage is required. More detailed information can be found in the Natural health products online system standard terminology user guide.

After the information has been entered, select the "Continue" button to save your changes and return to the Medicinal ingredients table.

Non-medicinal ingredients

Like medicinal ingredients, non-medicinal ingredients are selected by searching the Natural Health Products Ingredients Database. For all application types, the entire set of non-medicinal ingredients in the NHPID is searched.

Add non-medicinal ingredient

Search: In the non-medicinal ingredient search field, enter the full name of the non-medicinal ingredient to be added. The search field will search and retrieve data from the Natural Health Products Ingredients Database. The following fields are searched:

• NHPID approved name
• Proper names
• Common names
• Synonym

See section Ingredient search: General information for information on how to use the search function and what to do if a search returns no results.

Add to non-medicinal ingredients table: Select the desired ingredient from the search results to add it to the non-medicinal ingredients table.

Non-medicinal ingredients table

Ingredients that have been added to the non-medicinal ingredients table must be modified in order to complete the application. To complete the non-medicinal ingredient entry, click the "Modify" button corresponding to that ingredient.

Modify non-medicinal ingredient

On the Modify non-medicinal ingredient page, some fields will be pre-populated based on information found in the Natural Health Products Ingredients Database. If only one value is available, this value will be pre-selected.

Common name: Select the common name of the ingredient from the drop-down list.

Purpose: Select a purpose from the drop-down list of valid non-medicinal ingredient purposes. Please see the NHPID for the controlled list of acceptable non-medicinal ingredient purposes. If the required purpose is not found, complete an Ingredient issue form to add the desired purpose to the ingredient. Please ensure that the purpose is appropriate to the route of administration and the product, for example, certain purposes are only appropriate for topical products.

Standard or grade: Pharmacopoeia or other grade or standard with which the ingredient will comply. The drop-down list of standards and grades represents pharmacopoeia grades acceptable to the NNHPD. This field only needs to be completed as required or if applicable to the ingredient.

Quantity per dosage unit: If applicable, enter the amount of the ingredient used in the product formulation.

Unit of measure: Unit for the quantity. This drop-down list is populated based on the Natural health products online system standard terminology user guide. The most commonly used units (e.g. grams, micrograms, milligrams, milliliters and percent) are shown first followed by the other units in alphabetical order.

Animal tissue used: If the ingredient is derived from non-human animal tissue, check "Yes" and fill out the animal tissue form appended to the table of contents; otherwise check "No".

Is it nanomaterial?: If you are unsure, please consult the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials for more information. A "Yes" or "No" response is required. A "Yes" or "No" response is required. If the answer is "Yes", the nanomaterial is added to the list of nanomaterial ingredients on the summary page. Please note that nanomaterials are not permitted in the compendial application stream.

Source information: If applicable, describe the origin of the non-medicinal ingredient. This field is optional.

After the required information has been entered, select the "Continue" button to save your changes and return to the non-medicinal ingredients table.

Recommended use or purpose

For all application types, at least one use or purpose statement must be indicated.

For compendial and non-compendial applications that reference at least one monograph, the application form will pre-populate the recommended use or purpose statement(s) from the referenced monograph(s) based on the product's route of administration and medicinal ingredients. Select the statement(s) to be added by clicking on the corresponding checkbox(es). Statements with a checkmark next to them will be added to form and visible on the summary page. To deselect a statement, simply click on the corresponding checkbox to remove the checkmark.

For all Class III applications, a free text field is provided to input recommended use or purpose statements that are not derived from a monograph. If inputting more than one use or purpose statement, please indicate them individually in separate fields. To add another statement, click on the "Add a statement" button.

Recommended dosage

The recommended dosage section includes the "Add subpopulation groups" section, the "Subpopulation groups table" and the "Modify dosage" section. At least one recommended dose is required per product.

Add subpopulation groups: Use this section to first define the target subpopulation(s) for the product.

Age group: Options include infants, children, adolescents and adults. Select one or more age groups to define the age groups that make up the target subpopulation group. For compendial applications, these options will be restricted to the target age group identified on the specified monograph.

Sex: Options include Male, Female and N/A. The form will default to N/A. Only one option may be selected. Modify the selection if the product is specific for females or males.

Subgroup: Options include Postmenopausal, Premenopausal, Pregnant, Menopausal, and Breastfeeding. Checkboxes are enabled once "Females" is selected and one or more options may be selected.

Other subgroup: This option is only available for non-compendial applications. Use this free-text field to indicate a target subgroup that does not appear in the available subgroup options.

Age unit: This field is auto-populated with either "Month" or "Year" depending on the age group(s) selected.

Age - min: The minimum subpopulation age. The minimum acceptable value will be displayed in red text above the field. This value is generated based on previous selections for age group(s). A minimum age value is optional if "Adults" is the only age group selected. Note: If a minimum age is not provided for an adult subpopulations, the form will default the minimum age to 18 for validation purposes.

Age - max: The maximum subpopulation age. If the Adult age group has not been selected, the maximum acceptable value will be displayed in red text above the field. This value is generated based on previous selections for age group(s). The maximum age must be less than or equal to the maximum age of the oldest age group selected. A maximum value is not required if the oldest age group is "Adults".

Subpopulation group title: This text is generated from the selections made within the "Add subpopulation groups" section. This is the subpopulation group that will be added to the form. Review the subpopulation group title and click on "Add" to add it to the Subpopulation table. Repeat this task to add more subpopulation groups to the table.

Recommended dosage table

Subpopulations that have been added to the Recommended dosage table will be highlighted and marked as "to be completed". To complete the dosing information for a subpopulation group, click the corresponding "Modify" button. This action will take you to the Modify recommended dosage page (see below). Once the required information has been entered, the information will appear in the subpopulation groups table. All dosage information must be completed in order to complete the application.

Modify recommended dosage

Dosage and frequency: Required for oral and sublingual products as well as other products in discrete dosage forms. Min and max values must be numeric. The dosage form unit is chosen from a pick list based on the dosage form.

The frequency can be indicated per hour, per day, per week or per month.

Additional dosage information: Optional free text field. The additional dosage information becomes mandatory if the dosage form is non-discrete and no dosage information is provided.

Directions for use: Optional free text field and where applicable, pre-populated field(s). For compendial and non-compendial applications referencing at least one monograph, the form will pre-populate and pre-select all directions for use appearing on the referenced monograph(s), where applicable. Select the checkbox(es) corresponding to the statements you want added to the form. Statements with a checkmark next to them will be added to the form and visible on the summary page.

Click on the "Add directions for use" button to add another direction for use statement.

Note: Only the recommended use or purpose statements supported by the corresponding recommended dosage should be selected. A different subpopulation and recommended dosage combination must be added to the form for any use not yet supported by an existing dosage. To add another recommended dosage, repeat the steps to add a subpopulation group and click on "Modify". On the Modify recommend dosage page, add the recommended dosage and select the corresponding recommended use or purpose statements.

Duration of use

Duration statement: Optional free text field and where applicable, pre-populated field(s). For compendial and non-compendial applications referencing at least one monograph, the form will pre-populate and pre-select all duration of use statements appearing on the referenced monograph(s), where applicable. Statements with a checkmark next to them will be added to the form. Remove any duration statement that is not applicable to your product by clicking on the corresponding checkbox to remove the checkmark. Click on the "Add statement" button to reveal a free text field if you need to add another duration of use statement.

Risk information

Risk information consists of:

• Cautions and warnings
• Contraindications
• Known adverse reactions

For compendial and non-compendial applications referencing at least one monograph, the form will pre-populate and pre-select all risk statements found on the referenced monograph(s) based on the product route of administration and medicinal ingredients. Statements with a checkmark next to them will be added to the form. If certain risk statements are not applicable to your product, you can de-select the statement(s) by clicking on the associated checkbox to remove the checkmark. A free text field is available under each risk category in order to add your own risk statement. If additional statements are needed, click on the "Add" button under the appropriate risk category to reveal a free text field. Repeat this step to add more statements as required.

For non-compendial applications where no monograph is referenced, all risk fields are optional and free text. If additional statements are needed, click on the "Add" button under the appropriate risk category to reveal another free text field.

Animal tissue forms

Animal tissue forms table

An animal tissue form is added to the animal tissue forms table of the web PLA form each time "Yes" is selected in response to any of the four Animal Tissue questions:

• Product information page: "Is animal tissue used in processing?"
• Modify medicinal ingredient page: "Animal tissue used"
• Modify medicinal ingredient page (homeopathic ingredients only): "Was animal tissue used in the processing of this ingredient or natural lactose used for trituration?"
• Modify Non-medicinal ingredient page: "Animal tissue used"

If additional animal tissue forms must be provided for an ingredient, click the "Add animal tissue forms" button and select the corresponding ingredient under Medicinal Ingredient (MI), Non-Medicinal Ingredient (NMI), or Ingredient used in processing (IUP).

To remove an animal tissue form, click the "Remove" button beside the animal tissue form you would like to remove from the table. Please note that only additional animal tissue forms can be removed this way. To remove the primary animal tissue form(s), go to the relevant section of the form and change your animal tissue answer to "No".

Animal tissue forms that have been added to the table will be marked as "to be completed". To complete an animal tissue form, click the "Modify" button corresponding to that animal tissue form. This action will take you to the Modify animal tissue form page (see below). Once the required information has been entered, the information will appear in the Animal tissue forms table. All animal tissue form entries must be complete for successful finalization of the web PLA form.

Modify animal tissue form

For medicinal ingredients and non-medicinal ingredients identified as animal tissue, the "Name of ingredient" and "Used as" sections are auto-populated. For ingredient(s) used in processing, the ingredient name must be provided. See the Natural Health Products Management of Applications Policy for further details.

Label text

The "Label text" section of the form is a handy and reliable way to generate a product label directly from the information provided in the web PLA form. If the customization features are insufficient to produce the label information you need, then simply select "Label text submitted separately" and provide your own label as part of your submission package.

The content is organized by panel as per Section 93 of the Natural health products regulations and published in the Labelling guidance document.

As per the labelling guidance, there are five label text sections:

1. Principal display panel
2. Any panel
3. Outer label text only
4. Security package
5. Specialized labelling - inner and/or outer

The field values displayed in each section of the label text generator are populated from the information entered in the web PLA form. Mandatory fields are identified with an asterisk (*).

Once the finished results are satisfactory, click the "Continue" button to validate. Any aspects that are inconsistent with the Natural health products regulations and labelling guidance are highlighted for correction. When the label text validates cleanly, the applicant can then proceed to finalize the web PLA form.

Principal display panel: In the Principal display panel section the "Net amount in container" field is a mandatory field that can be modified by the user. By selecting "Text entry" in the weight/measure/number drop-down, you can input your own container units.

Note: The weight/measure/number field can be used to show multiple container amounts for the same product.

Any panel: The Any panel section includes:

• Applicant or licence holder
• Medicinal ingredient
• Recommended use or purpose
• Duration of use
• Recommended dosage
• Cautions and warnings
• Contraindications
• Known adverse reactions
• Recommended storage conditions
• Lot label

Most fields within this section are fixed based on previously entered information and cannot be revised, with the exception of recommended storage conditions, which is an optional field.

Outer label text only: The Outer label text only section includes Non-medicinal ingredients and an optional mercury statement. The non-medicinal ingredient field is fixed and can only be changed by modifying them in the Non-medicinal ingredient section of the web PLA form. Select "Include [NMI] quantity on label" if you want the NMI quantity(ies) to appear on the final label text. For the mercury statement, the default selection is "No". If the product contains mercury, you must select "Yes", and complete mandatory "Quantity of mercury statement" information. The mercury statement will only appear on the label if "Yes" is selected.

Security package: All fields within the Security package section are mandatory. If the product packaging's security feature is not self-evident then a Security Feature statement must be specified.

Specialized labelling: The content of the specialized labelling section depends on the application type. For compendial, traditional, and general applications, the specialized labelling section contains five optional subsections to be completed as applicable:

1. Pressurized Container
2. Cautionary Statements
3. Organic Product Statements
4. Irradiated Product Statements
5. Eucalyptus/Camphor Product Statement

For Homeopathic applications (compendial and non-compendial), the Specialized labelling section contains the five optional subsections listed above and a Homeopathic medicines labelling subsection.

Other label functions: The label text can be viewed at any time on the summary page. To copy and print the label text alone, select the text by highlighting it within the summary page and clicking Ctrl + "C". The text can now be pasted into any text editing program and printed from there.

Please note that copying and pasting the label text elsewhere in this way is a "one-way" operation. Label text modified within another software application cannot be imported back into the web PLA form. If you wish to include the modified label text in your submission, you must submit it separately and click on "Label text submitted separately" in the Label text section of the web PLA form.

For more information on Natural health product labelling, refer to the Labelling guidance document.

Summary

The Summary page displays the contents of each section of the web PLA form in one consolidated view. The summary can be viewed at any time during an active session by clicking on "Summary" in the top right hand corner of the form or by selecting "Summary" in the table of contents.

Completing the form: Once all sections of the form have been completed and all required information has been entered, click on "Complete" at the bottom of the summary page. Errors will appear if required information is missing. All errors must be resolved in order to complete the form and move forward with either monograph validation in the case of Compendial class I applications, or the attestation section in the case of non-compendial applications.

Validate compendial application

The "Validate compendial application" operation is available for all compendial applications completed using most current web PLA form. Once form-level verification is complete, the "Validate compendial application" button will appear. Click on this button to activate the monograph validation service. The validation service will verify that the information provided in the form complies with the specified monograph. If so, the service will return a message of compliance and the attestation section will appear. If the information does not comply with the specified monograph, the validation service will return a message of non-compliance accompanied by the failure reasons. If this happens, the errors must be revised in order to pass validation and finalize the form.

Different validation results

If you run validation on a previously saved Class I file, you might obtain a different validation result. This can happen when the data saved to your form since your last session is no longer consistent with the data found in the NHPID. Revisions to the NHPID, such as ingredient or monograph updates, can affect functionality in the form if the form has not been updated accordingly. In order to proceed, please review the information in your form, such as medicinal ingredient names, source information, extract information, and monograph statements, and either remove and re-enter the data or revise it in accordance with the monograph or NHPID.

Attestation

Before finalizing the form, carefully review the summary and read the attestation at the bottom of the page. To sign the attestation, select the "I agree" checkbox. This will generate an attestation code which acts as your confirmation that you accept the terms of the attestation.

Finalize Once attestation is complete, the Finalize button will appear. Click on "Finalize" to lock the form, generate a unique tracking number and go to the finalized view.

Finalized form

The finalized form includes the tracking number, complete summary, and a signed attestation. Once finalized, the file is ready to save to your local workstation. The saved .html file is then ready to submit to NNHPD as part of a complete product licence application package. See the Natural Health Products Management of Applications Policy for more information on submission package requirements.

Note: Use the "Save file" link provided in the form to download and save a copy of your web PLA form to file. Do not save using the browser's save function as this will only save the web page not the form.

Modify

The "Modify" button is available after a form has been finalized. Use this button when you are responding to an information request notice from NNHPD or if you are doing any modifications to the form prior to submission. Do not use the modify function to change the content of an application after a refusal is issued or to create new applications as this will result in a duplicate tracking number. New submissions containing a duplicate tracking number cannot be processed and will be refused.

After selecting the "Modify" button and making the desired change(s), be sure to save any modified fields by clicking on the corresponding "Continue" button.

Monograph updates

If your application includes monograph information, be sure to review this information prior to finalizing the form. This includes medicinal ingredient information such as ingredient names, sources and extract information and statements such as use or purposes, directions for use, duration of use, and risk statements. You may notice that some information is no longer available or that statements have been deselected (removed). This will occur when the data saved to your form during your last session is no longer consistent with the ingredient and monograph data found in the NHPID. Revisions to the NHPID, can affect functionality in the form if the form has not been updated accordingly. In order to proceed, please ensure all monograph-related information remains accurate and that all required statements are still included. Once you are certain the data is accurate, you can proceed to the summary page and finalize the form.

Note: See the section "Load application form from file" for more information on how to modify the web PLA form pre and post finalization.

Submitting to the NNHPD

The web PLA form must be submitted in HTML format only. The NNHPD accepts completed submission packages via epost Connect^TM by using the "nhpsn.epostel.applications"" conversation. To use epost Connect^TM you must first enroll as a Trading Partner. For more information on how to become a trading partner, please refer to the Guidance document on how to interact with the NNHPD electronically.