Natural health product licence application form user manual
Help index
- Natural Health Product licence Application form: Overview
- Recommendations for optimal results
- General
- Specialized
- Natural Health Product licence Application form
- New application
- Load saved application from file
- Applicant or licensee
- Contact information
- Site information
- Application information
- Product information
- Medicinal ingredients
- Add medicinal ingredient
- Ingredient search: general information
- Medicinal ingredients table
- Modify medicinal ingredient
- Non-medicinal ingredients
- Add non-medicinal ingredient
- Modify non-medicinal ingredient page
- Recommended use or purpose
- Recommended dose
- Sub-population groups table
- Modify recommended dose
- Duration of use
- Risk information
- Animal tissue forms
- Animal tissue forms table
- Modify animal tissue form
- Label text
- Summary
- Attestation
- Finalized form
- Saving the web PLA form
Natural health product licence application form overview
The web-based Product Licence Application (PLA) form is for natural health product licence applications. It is designed to be completed online and saved to the applicant's workstation where it can be retrieved at any time. Through an active Internet connection, the form can automatically access the Natural Health Products Ingredients Database (NHPID) to search medicinal and non-medicinal ingredients and populate fields with ingredient related information as well as to populate pre-cleared information when attesting to monographs in the Compendium of monographs.
This help section provides information on how to successfully complete the web PLA form. For information on the terminology used in this 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 Management of product licence applications for natural Health products 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.
For additional information on the web PLA form 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
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 a help page within the form and take you to the corresponding section of the help text. While on the help page, you can scroll up and down to continue reading, or select index to view a list of all sections of the user guide and navigate to the specific section you are looking for. To exit the help page and return to the form, you can click anywhere outside the help text or click "Esc" (escape) on your keyboard.
Become familiar with monographs
Before selecting a monograph in the web PLA form, be sure to review its attributes online (using the Natural Health Products Ingredients Database) to understand any limitations on conditions of use. You may find that another monograph more closely meets your needs or that no monograph supports the specifics of your product.
Become familiar with the Natural Health Products Ingredients Database
The web PLA pulls information related to the medicinal and non-medicinal ingredients in the product directly from the NHPID. This feature will ensure consistency in ingredient representation by restricting entries to only what is acceptable as per the NHPID. To better understand how to find your ingredient using the web PLA, it will help to become familiar with the Natural Health Products Ingredients Database and its terminology.
Become familiar with the Management of Applications Policy (MAP)
Before using the web PLA form, it is very important to become familiar with the application types for natural health products (see the Management of applications policy). Certain changes - such as changing the Application type on the Application information page after having begun to complete the form - may 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.
Meet the system requirements and enable JavaScript
While the web PLA functions in most browsers, for best results, we recommend using either Firefox 54+ or Chrome 60+. The web PLA also requires you to have JavaScript enabled in your browser. When JavaScript is not enabled, a number of errors or issues occur such as buttons not working, the inability to type in certain text fields, and the absence of French terms when the selected language is French, to name a few.
Click on enable JavaScript to find the instructions specific to your browser.
If you have concerns with making these changes to your security settings, consult with your IT security advisor first.
Save your progress – sessions will timeout
The web PLA form may be saved at any time on your workstation and resumed at a later time. During an active session, any data you enter in the form will be 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 the form, it is important to save your progress before ending the session.
Allow webpages to refresh before continuing
If you begin to make selections and enter information before the webpage has fully refreshed the information will be lost. Depending on your internet speed it might take a few seconds for the webpage to refresh. To prevent entering the same information twice, allow the webpage to refresh before continuing.
Specialized
Validate as you go
Where applicable, always select the "Continue" button to validate the content before moving onto the next section. The web PLA is continually applying validation rules to ensure that the information being captured is as accurate and complete as possible. After the information for a page has been entered, check for all potential errors before proceeding, then select the "Continue" button to validate the content.
Where information is incorrect or where a required field has not been filled, an error message will be displayed above the page indicating which field has missing or incorrect information. The affected field(s) will also be highlighted in red. 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 validated.
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 (required), after the field label.
Create templates
When submitting multiple product licence applications to the NNHPD, it may be worth saving templates of the form. For instance you may save a copy of the form once all the contact information is entered 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 the need to repeatedly fill out the same information.
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 since the results can be unpredictable when using the browser's backward and forward buttons.
Table of contents: The table of contents can be accessed from the top right and bottom center 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, select "Summary" at the top right of the form to review your information.
Save: Select "Save" to save a copy of the PLA to your local drive. The file will be saved in HTML format. 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 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 drive.
Back to list of records: Several subsections of the PLA, such as the "Modify medicinal ingredient" subsection, will display a link that navigates back to the list of records (e.g. "Back to medicinal ingredients table") instead of the usual previous and next buttons. Use this link to return to the corresponding table without saving or modifying any information on the page. If you wish to save the changes made on that page, you must select "Continue" instead.
New application
From the landing page, select "New application" to start a new Product licence Application form.
Load saved application from file
The "Load saved application from file" option allows you to load a previously saved PLA form back into the web application. Only web PLA files saved in HTML format can be loaded back into the web application. Depending on whether the web PLA form is finalized or not, different load options will appear.
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 PLA. From the summary page, use the table of contents to navigate to any section of the 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 name
Once a form has been selected, three actions are possible:
- View summary: Select this to view the finalized summary without unlocking the form for editing.
- Modify: Select modify to open and unlock 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: Select this option to copy all the contact information from a finalized form into a new form. This action copies all information on the Applicant/licensee and Contact information pages and clears the rest of the form, including the tracking number.
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 for the purpose of submitting a new application if the original form has already been submitted.
Applicant or licensee
The Applicant or licensee page captures information about the company in whose name the product licence is to be registered (the applicant will be referred to as the licensee once a licence has been granted).
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).
After the information has been entered, select the "Continue" button to save and navigate to the next section of the form.
Company Code
The company code is a unique five digit code which is 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. Do not use a third party contact's company code on this page as this will cause a delay in the processing of your submission and may result in the rejection of your application. If you do not have a valid applicant/licensee company code, please submit a request via the email address and indicate "Request for a company code" 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 information
The contacts table automatically includes a row 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.
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.
The contact for this application 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 (3rd party consultant). There may be more than one contact indicated per application.
The representative in Canada is the person to whom NNHPD will direct regulatory mail and who is responsible for the sale of this product in Canada. There must only be one representative in Canada indicated per application. Any person with a Canadian address may act as the representative in Canada; however, this person will bear all responsibilities of the applicant or licensee.
Note:A Representative in Canada is only required to be indicated on the PLA form if the applicant or licensee's address is outside of Canada.
Site information
If this information is known/available at the time of applying for a product licence, the applicant should indicate all of the sites used in the manufacturing, distribution, labelling, packaging, and if applicable the importation of the Natural Health Product (NHP). The applicant should provide the name and address of each company.
For each company name and address provided, the associated activity/activities must also be indicated (such as manufacturer, packager, labeller, distributor, and/or importer.) If available, the site licence number assigned by the NNHPD should also be provided.
To input site information, select the "Add a site" button. In the Site information table select modify next to the corresponding site. On the Site page, input all required information and 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.
After the information has been entered, select the "Continue" button to save all entered information and return to the site information table. For more information on completing the site information section of the PLA form, please refer to the Product licensing guidance document.
Application information
Application type
The available types of applications are as follows:
- Traditional;
- General (non-traditional);
- Compendial (including compendial homeopathic); and
- Homeopathic (non-compendial).
The type of application selected in the Application Information section determines the layout and behaviour of the web PLA.
Monograph
A monograph selection is required for compendial applications where the entire product must comply with the chosen monograph for safety, efficacy and quality. For all other application types, attestation to one or more monograph(s) is at the individual medicinal ingredient level where applicants can choose to attest to safety, efficacy and/or potency.
Is this formulation hypothetical?
Select either yes or no to indicate whether or not this formulation is hypothetical. If no is selected, and you intend to market the product shortly after licensing, please complete the Site information section of the form.
Reference submission
The Reference submission section is fillable for all application types except for compendial applications. 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) or Drug Identification Number (DIN, or DIN-HM). Indicate the summary report(s) being referenced by checking the appropriate box for safety, efficacy, and quality. A letter of access must be enclosed with the submission, as applicable.
Should an applicant wish to reference more than one submission, select the "Add reference" button to display another reference submission field. Any of these reference submissions can be removed by clicking on the "Remove" button.
NNHPD master file reference
The NNHPD master file reference section is always displayed. 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, please refer to the Master file procedures guide.
For more information on application requirements and information required to complete the Application information section, please refer to the Product licensing guidance document.
After the information has been entered on the Application information page, select the "Continue" button to save all entered information and navigate to the next section.
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.
Route of administration: The route of administration is a pick list populated from the Natural Health Products Ingredients Database Standard Terminology. For a compendial application referencing a single ingredient monograph, the route of administration is pre-determed by that monograph. For all other applications (including compendial applications referencing a product monograph), 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 Harmonisation (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, when the route of administration is "Ophthalmic", the sterile field is set to "Yes" and locked.
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".
After the information has been entered, select the "Continue" button to save all entered information and proceed to the Medicinal ingredients section.
Medicinal ingredients
The Medicinal ingredients section captures information on the medicinal ingredient(s) associated with the product in the medicinal ingredients table.
Note: The ingredients found in your product, both medicinal and non-medicinal, must be indicated as such in the NHPID prior to completing the web PLA form.
In compendial applications where a single ingredient monograph is selected, the medicinal ingredient will be automatically added to the Medicinal ingredients table. If a product monograph is selected, medicinal ingredients are added one-by-one by searching and selecting an ingredient in the Add medicinal ingredient section of the page. This is also true when the Homeopathy monograph is selected.
For all other application types, ingredients are added one-by-one, by searching and selecting a monograph and/or an ingredient in the Add medicinal ingredient section of the page. The search function is based on the Natural Health Products Ingredients Database Standard Terminology. Please refer to the Natural health product online system standard terminology guide for further information regarding the naming terminology.
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 when filling out the web PLA, as some ingredients may appear to be the same but have differences in constituents, extract information, methods of preparation, etc.
- If the required ingredient information cannot be found in the NHPID, you can submit a formal request to add the information through the Natural Health Products Ingredients Database Issue process (see Natural Health Products Ingredients Database issue form user manual). Please consult the Natural Health Products Ingredients Database issue form user manual for details on its use. For controlled vocabulary listings, please consult the NHPID's controlled vocabulary search. Completed NHPID Issue forms must be sent to ingredient_support for review and inclusion in the NHPID.
Add medicinal ingredient
The Add medicinal ingredient section at the top of the page allows you to attest to a monograph for a specific medicinal ingredient and search for a medicinal ingredient to be added to the form.
compendial applications: The Add medicinal ingredient section is enabled if you are attesting to a product monograph. If attesting to a single ingredient monograph, the medicinal ingredient is automatically added to the form and the Add medicinal ingredient section is disabled.
non-compendial applications: The Add medicinal ingredient section is enabled for all non-compendial applications.
Monograph attestation
For non-compendial applications, begin by indicating whether or not you are attesting to a monograph for the medicinal ingredient to be added. If "Yes", a monograph must be selected from the drop-down list. Click on "Select" to load the chosen monograph. If "No", the Medicinal ingredient keyword search box will be available for input. This step is not required for compendial applications referencing a product monograph since the monograph selection is made on the Application information page.
Monograph drop-down and search
The monograph search field will appear if you are attesting to a monograph for the medicinal ingredient to be added. 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 be automatically displayed to the right of the search area. If you select a product monograph, the Medicinal Ingredient search field will appear.
Medicinal ingredient search
The medicinal ingredient search field will appear if you are not attesting to a monograph or if you are attesting to a product 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. Search results will appear in alphabetical order of NHPID approved name under the "Add to Medicinal ingredients table" header with a message indicating the number of results. If many search results are returned, a filter will appear to help narrow the search results even further.
For general and traditional applications, if you are not attesting to a monograph, the search will include all non-homeopathic medicinal ingredients found in the NHPID.
For compendial, general and traditional applications where a product monograph is selected (excluding the homeopathy monograph), the search will include all non-homeopathic medicinal ingredients that are present in NNHPD monographs. These ingredients are also referred to as pre-cleared information (PCI) ingredients.
For compendial and non-compendial homeopathic applications attesting to the homeopathy monograph, the search includes only homeopathic ingredients seen in the following five references: Homeopathic Pharmacopoeia of the United States (HPUS), Encyclopedia of Homeopathic Pharmacopoeia (EHP), German Homeopathic Pharmacopoeia (HAB), European Pharmacopoeia (PhEur), and Pharmacopée française (PhF).
If you are attesting to a product monograph and your search returns no results, it likely means that the ingredient does not appear in an NNHPD monograph. Review the product monograph to ensure you are entering the correct medicinal ingredient name, or remove the attestation to open the search to all medicinal ingredients in the NHPID. See Ingredient Search: general Information for more information on conducting a search and what to do if a search returns no results.
Add medicinal ingredient to table
The medicinal ingredient search results will be displayed under the "Add to medicinal ingredients" header. For non-compendial applications attesting to a single ingredient monograph or a product monograph, prior to clicking the "Add" button or selecting an ingredient from the returned results, you must specify what in the monograph you are attesting to: safety, efficacy, and/or quality. For non-compendial applications not attesting to a monograph, select the desired medicinal ingredient from the search results to add it to the Medicinal ingredients table.
Ingredient search: general information
The search field is designed to search and retrieve data from the Natural Health Products Ingredients Database. The following fields are searched:
- NHPID name;
- Proper names;
- Common names;
- Synonym;
- Taxonomical synonyms (Taxa); and
- Chemical Abstracts Service (CAS) numbers.
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 manual. 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 that 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).
Medicinal ingredients table
Medicinal ingredients that have been added to the Medicinal ingredients table will be 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, the information will appear in the Medicinal ingredients table. All required MI entries must be complete in order to finalize the form.
Modify medicinal ingredient
For non-homeopathic applications, if you are attesting to a monograph for a particular medicinal ingredient, some of the fields on the Modify medicinal ingredient page will be pre-populated based on a combination of information found in the corresponding monograph and the Natural Health Products Ingredients Database (NHPID). If you are not attesting to a monograph, the ingredient fields will be pre-populated based on information found in the NHPID only.
For all homeopathic applications (compendial and non-compendial), the ingredient fields will be pre-populated based on 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 for the web PLA.
Proper name: Ingredient's proper name. Select one from the pick list. For compendial applications and medicinal ingredients attesting to a monograph, if there is only one applicable Proper name, it will be pre-selected. All proper names are pre-populated from the Natural Health Products Ingredients Database and are based on the Natural health products regulations.
Common name: Common name of the ingredient. 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 pharmacopoeia presents pharmacopoeial grades acceptable to the NNHPD. The Standard or Grade is required for homeopathic applications
Quantity per dosage unit: Amount of the ingredient used in the product formulation per dosage unit. This must be a number 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".
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: Select the source material from the drop-down list provided, if applicable. If there are many source materials included in the formulation, click the "Add a source material" button. When an ingredient is derived from an organism group, the Source Material drop-down will include not only the group, but also the group components. For example, for the ingredient 'Oyster Shell', the source material will consist of not only the 'Oyster' group and the relevant 'Shell' part, but also the individual genus/species associated with this group along with the relevant part. For ingredients having both source ingredients and source material, there must be a selection from at least one of the two fields.
Source: From the pick list, select the ingredient source from which the ingredient was isolated, if applicable. Multiple selections can be made.
Method of preparation: The preparation method used for the ingredient is required only for organism and organism substance types. A drop-down list of methods of preparation is populated for organisms and defined organism substances. Detailed information on the NNHPD methods of preparation can be found in the Natural health products online system standard terminology user manual.
For homeopathic applications only: An "Add method of preparation" button is available to enable free text entry of method of preparation.
This ingredient has a constituent or sub ingredient: Check this box if the medicinal ingredient has a constituent or sub ingredient.
This ingredient is an extract/has a solvent: Check either or both of these boxes if the medicinal ingredient has an extract and/or a solvent. The detailed information about processing organism ingredients is required only for organisms. More detailed information can be found in Section 4.1 - Approved organism substance preparation name of the Natural health products online system standard terminology user manual.
Potency/sub ingredients:
- Constituent: Choose the constituent 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:
- Original material used: It must be indicated whether the original material used is dry or fresh. If "Fresh" is selected, a mandatory field entitled "Fresh to Dry Ratio" appears.
- Quantity crude equivalent: The quantity of crude material equivalent to the final preparation. Both the quantity and unit of measure are required.
- Ratio: Ratio of the quantity (usually weight) of raw material used to the quantity (weight or volume) of final preparation. The web PLA will automatically calculate the ratio, which is not editable, when the quantity per dosage unit and the quantity crude equivalent are both provided. More detailed information can be found in the Natural health products online system standard terminology user manual.
Solvents:
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 percentages is required. More detailed information can be found in the Natural health products online system standard terminology user manual.
After the information has been entered, select the "Continue" button to save all entered information 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 keyword 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 name;
- Proper names;
- Common names;
- Synonym;
- Taxonomical synonyms (Taxa); and
- Chemical Abstracts Service (CAS) numbers.
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 page
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 name of the ingredient from the drop-down list of common names.
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.
Standard or grade: Pharmacopoeia or other grade or standard with which the ingredient will comply. The drop-down list of standards and grades represents pharmacopoeial 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 manual. The most commonly used units (e.g. grams, micrograms, milligrams, millilitres and percent) are shown first followed by the other units in alphabetical order.
Animal tissue used: If source material is non-human animal, 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 information 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). Select the statement(s) you want 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 non-compendial 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 dose
At least one recommended dose is required for all products. One set of dosing information is captured for each sub-population group as shown below.
Sub-population group: Either select one of the provided sub-population groups or enter your own subpopulation, including age range, by selecting "Add other sub-population". Once selected or entered, click on "Add" to add it to the Sub-population table. Repeat this task to add more sub-population groups to the table.
Sub-population groups table
Sub-populations that have been added to the Sub-population groups table will be marked as "to be completed". To complete the dosing information for a sub-population group, click the corresponding "Modify" button. This action will take you to the Modify recommended dose page. Once the required information has been entered, the information will appear in the sub-population groups table. All entries must be complete in order to complete the application.
Modify recommended dose
Dosage and frequency: Required for oral products and other discrete dosage forms. Min and Max values must be numeric. Dosage unit is chosen from a pick list based on the dosage form.
The frequency default is "per day".
Note: If dose is 1 capsule 1x/day, enter '1' in the min and max fields for dosage and frequency.
Additional dosage information: This is an optional free text field. The additional dosage information becomes mandatory if the dosage form is non-discrete and no dosage information is provided.
Directions of use: This is an optional free text field. For compendial and non-compendial applications referencing at least one monograph, the form will pre-populate and pre-select all directions of use appearing on the referenced monograph(s), where applicable. Statements with a checkmark next to them will be added to the form and visible on the summary page. You can remove any directions of use statement that is not applicable to your product by clicking on the corresponding checkbox to remove the checkmark.
Duration of use
Duration statement: This is an optional free text field. For compendial and non-compendial applications referencing at least one monograph, the form will pre-populate and pre-select all duration statements appearing on the referenced monograph(s), where applicable. Statements with a checkmark next to them will be added to the form and visible on the summary page. You can 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 statement.
Risk information consists of:
- Cautions and warnings;
- Contraindications; and
- 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). Statements with a checkmark next to them will be added to the form and visible on the summary page. 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. If additional statements are needed, click on the Add statement button under the appropriate risk category to reveal a free text field. Repeat this step to add more statements as required. If inputting more than one risk statement, please indicate them individually in separate fields. To add another statement, click on the "Add statement" button.
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 Statement" button under the appropriate risk category to reveal another free text field.
An animal tissue form is added to the animal tissue forms table of the web PLA 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 triturations?"
- 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 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. 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.
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...
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. 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 generated label text is assembled from the information entered in the web PLA. The content is organized by panel as per Section 93 of the Natural health products regulations and published in the Labelling guidance document. 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.
As per the labelling guidance, there are five label text sections:
- Principal display panel;
- Any panel;
- Outer label text only;
- Security package; and
- Specialized labelling - inner and/or outer.
The field values displayed in the sections are from previous sections of the web PLA form. Mandatory fields are identified with an asterisk (*). Some field values can be either included on or removed from the label text by selecting or deselecting the corresponding "Include on Label "checkbox.
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 dose;
- Cautions and warnings;
- Contraindications;
- Known adverse reactions;
- Recommended storage conditions; and
- 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 and lot label, which are optional fields that may be completed.
Outer label text only: The Outer label text only section includes Non-medicinal ingredients and a 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. For the mercury statement, select either "Yes" or "No" depending if the product contains mercury or not. If the product contains mercury, a mandatory field entitled "Quantity of mercury statement" will appear and must be completed.
Security package: All fields within the Security package section are mandatory fields on the label. If the security feature is not self-evident in the product packaging, 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:
- Pressurized Container;
- Cautionary Statements;
- Organic Product Statements;
- Irradiated Product Statements; and
- Eucalyptus/Camphor Product Statement
For Homeopathic applications (compendial and non-compendial), the Specialized labelling section also contains the five optional subsections listed above along with an additional 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 Control "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. This means that if you wish to use the modified label text for the Product licence Application, you must submit the modified text separately from the web PLA 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 open session by clicking on "Summary" in the top right hand corner of the form or by selecting "Summary" in the table of contents.
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 or incorrect. All errors must be resolved in order to finalize the form.
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. After agreeing with the attestation statements 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 be saved in HTML format to your local workstation. The saved .html file is then ready to be submitted to NNHPD as part of a complete product licence application package. See the Management of applications policy for more information on what consists of a complete submission package.
Submitting to the NNHPD
The web PLA form must be submitted in HTML format. The NNHPD accepts completed submission packages (including the web PLA in HTML format) via epost ConnectTM by using the "nhpsn.epostel.applications"" conversation. To use epost ConnectTM you must first enrol 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.
Warning: Do not print and then scan the web PLA form. Submitting a scanned web PLA form to the NNHPD will result in lengthy processing delays and may result in a rejection of your submission.
Modify
The "Modify" button must only be used when responding to an information request notice from NNHPD or if you're doing any modifications to the form prior to submission. It should not be used to change the content of refused web PLAs or to create new applications from previously finalized applications with similar content. The latter actions will result in duplicate tracking numbers at NNHPD which causes serious delays in file processing.
After selecting the "Modify" button in order to respond to an information request as part of the application process and making the desired change(s), be sure to save any modified fields by click the "Continue" button at the end of the section (i.e. Applicant and contact information, Application type, Site information, Product information). The "Complete" button will need to be selected again in the Summary section in order to validate that all required fields have been filled. The label text also needs to be re-validated, and the application form needs to be successfully finalized before the updated form can be submitted.
Saving the web product licence application form
To save your progress or to create a template, click the "Save" link at the top right of the web PLA form. This will create an HTML file which can then be saved to your workstation. You may be prompted to save the file to a specific location, or the file may save automatically to your default download folder.