Are Probiotic Sodas, Stress-Relieving Tonics, and Other So-Called Healthy Drinks Good ingredieent You? All rights reserved. Vitamin C mg Caplets.

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Please contact ARL or info arlok. com with questions. Potency Testing Benefits and Requirements. Potency Testing Benefits and Requirements Potency testing measures the concentration of the active pharmaceutical ingredient API.

This essential test ensures the API concentration matches its intended amount and provides value-added benefits to pharmacies including: Supports product compliance checks.

Establishes compounding process controls. Confirms the preparation is accurate and precise. Provides documentation references for regulatory audits and patient questions. Supports sales tools demonstrating a dedication to quality. Check out Continue shopping.

WE CARE ABOUT. Purity We care about the quality, purity, and efficacy of our products. Where It Starts. Related Stories. LEARN MORE. Third-Party Testing. VISIT ISURA. Clean Ingredients Quality vitamins and supplements begin with quality ingredients.

Therefore, it is only natural that our approach to product safety and quality starts with farmers and suppliers, and continues up the entire supply chain All ingredients are extensively tested before they are accepted for use in our products.

Clean Manufacturing We are one of the very few in our industry to insist on controlling the manufacturing process from start to finish.

In-House Testing We are obsessive about testing. Making a Difference We use these products ourselves and give them to our loved ones. Related ARTICLES. mins read. Our Nature. The Source. Learn more. The Planet. Repeat this task to add more subpopulation groups to the 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. 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. 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. 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 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. 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.

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. 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:.

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. 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. 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.

The field values displayed in each section of the label text generator are populated from the information entered in the web PLA form.

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.

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:. 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. 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. 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.

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.

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.

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.

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. 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.

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. 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.

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. Warning: Do not provide a scanned or PDF copy of the web PLA form.

Submitting a scanned or PDF web PLA form instead of the. html version to the NNHPD will result in the refusal of your submission. If they are submitted in addition to the. html form, the NNHPD will not consider these during screening and review.

Help index. Skip to main content Skip to "About this site". 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.

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.

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.

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. 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.

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. 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.

Create templates When submitting multiple product licence applications to the NNHPD, it is worth saving templates prior to completing and finalizing the form. Use the form's navigation features The web PLA has several navigation features that are consistent across the entire form.

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.

When a finalized form has been selected, three actions are possible: View summary : Opens the finalized summary page without unlocking 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. 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.

Company Code A company code is the unique five-digit code assigned to an individual company by the NNHPD. 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.

Senior Official The senior official is the principal contact person for the applicant or licensee, at the address given. Application contact The application contact is the person to whom NNHPD will direct product-specific questions.

Representative in Canada The representative in Canada is the person to whom NNHPD will direct regulatory mail. Site information If the application is for a non-hypothetical product, then site information is required in order to finalize the application form.

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.

Monograph A monograph selection is required for compendial applications where the entire product must comply with the chosen monograph for safety, efficacy and quality. Application class If the application type is compendial, the form will auto-select class I and disable the other two class options.

This application is for a kit If the application is for a kit, please select the button "This application is for a kit". Reference submission The Reference submission section is fillable for all application types except for Compendial. NNHPD master file reference The NNHPD master file reference section is optional for all application types.

Product information General information about the product is collected on the Product information page. 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.

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. 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.

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

Monograph attestation For non-compendial applications, begin by indicating whether you are attesting to a monograph. Monograph selection Locate the monograph you are attesting to in the drop-down list and click "Select" to confirm your selection. Medicinal ingredient search The medicinal ingredient search field will appear if you are not attesting to a monograph.

Adding a medicinal ingredient to the medicinal ingredients table The medicinal ingredient search results will display to the right of the search area. Ingredient search: general information The search field is designed to search and retrieve data from the NHPID.

The following fields are searched: NHPID approved name; Proper names Common names Synonym Selecting a filter: The search engine has a default of all ingredient types. Standard dosage unit information Standard dosage unit refers to a determinate quantity of product, against which each medicinal ingredient quantity is expressed, e.

Medicinal ingredients table Medicinal ingredients that have been added to the Medicinal ingredients table will be highlighted and marked as "to be completed".

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.

The Standard or Grade is required for homeopathic applications Quantity per standard dosage unit: Amount of the ingredient per standard dosage unit. Source Information Source material: If applicable, select the source material Latin binomial name and organism part from the drop-down lists 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. 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.

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