Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/natural-health-products/electronic-product-licence-application-user-manual.html
Timestamp: 2017-07-26 02:44:51
Document Index: 41915338

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Natural Health Product Licence Application Form User Manual - Canada.ca
The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change. Thank you for your patience and understanding. (PDF Version - 2640 K)
Natural Health Products Online Solution Natural Health Products Ingredients Database Electronic Product Licence application form Related Guidance Documents Table of Contents
1.0 Natural health product licence application form overview 2.0 Recommendations for optimal results 2.1 General 2.2 Specialized 3.0 Natural health electronic Products Licence Application form 3.1 Overview 3.2 Applicant and contact information (Part 1) 3.3 Application type (Part 2) 3.4 Site information (Part 3) 3.5 Product information (Part 4) 3.5.1 Product information overview 3.5.2 Non-homeopathic applications 3.5.3 Homeopathic applications 3.5.4 Applications with non-oral routes of administration 3.6 Label text (Part 5) 3.6.1 Label text editor 3.6.2 Edit and validate label text 3.6.3 Label text submitted separately 3.7 Animal tissue form 3.8 Product licence application (finalize) 3.8.1 Product information summary 4.0 Using the ePLA form after submission 4.1 Corrections to a submitted form 4.2 Post-licence activity 4.3 New application activity 4.4 Importing an application List of figures
Figure 1 - Progressive Assembly of an ePLA Figure 2 - Applicant or Licensee Information Figure 3 - Senior Official Information Figure 4 - Contact for this Application Information Figure 5 - Representative in Canada Information Figure 6 - Example of Type of Application Figure 7 - Reference Submission Information Figure 8 - Master File Information Figure 9 - Site Information Figure 10 - Heading for Product Information Figure 11 - Remove an existing Medicinal Ingredient Figure 12 - New (empty) Ingredient Figure 13 - Example of a Successful Ingredient Search Result Figure 14 - Ingredient names Figure 15 - Basic Information of the Ingredient Figure 16 - Source ingredient Figure 17 - Source Material Figure 18 - Source Material and Strain Figure 19 - Methods of Preparation Figure 20 - Potency Figure 21 - Extracts and Solvents Figure 22 - Subingredient Figure 23 - Non-medicinal Ingredient Information Figure 24 - Ingredient(s) Used in Processing Figure 25 - Recommended Use(s) or Purpose Figure 26 - Recommended Dose Figure 27 - Duration Statement Figure 28 - Risk Information Figure 29 - Nanomaterial Ingredients Information Figure 30 - Homeopathic Medicine Labelling Standard (HMLS) Attestations Figure 31 - Homeopathic Specific Attestations Figure 32 - Homeopathic Non-Specific Attestations Figure 33 - Example of a Homeopathic Ingredient Search Result Figure 34 - Successful Ingredient Selection for Homeopathic Application Figure 35 - Example of topical product - Part 4A Figure 36 - Example of a Topical product - Part D Figure 37 - Front Panel Section Figure 38 - Product License Holder Subsection Figure 39 - A - Medicinal Ingredient Subsection Figure 40 - D - Recommended Conditions of Use Subsection Figure 41 - Recommended Dose Subsection Figure 42 - Risk Information Subsection Figure 43 - Provided by Applicant Subsection Figure 44 - Outer Label Text Only Section Figure 45 - Security Package Subsection Figure 46 - Successful Label Text Validation Result Figure 47 - Successful Label Text Validation in ePLA Figure 48 - Label Text Submitted Separately Checkbox Figure 49 - Animal Tissue Form Added Message Figure 50 - Attestation block common to all application types Figure 51 - Attestation block for Compendial applications Figure 52 - Successful Form Finalization Message Figure 53 - Product information summary report Figure 54 - D. Post-Licence Change List of tables
Table 1 - Types of ePLA applications 1.0 Natural health product licence application form overview
The Electronic Product Licence Application (ePLA) form is for Natural Health Product Licence Applications and for post-licence changes. The ePLA is designed to be completed on the applicant's workstation where it can be saved and retrieved at any time. Through an active Internet connection, the form can automatically access the Natural Health Products Ingredients Database (NHPID) to provide drop-down selections of medicinal and non-medicinal ingredients and related information.
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After doubling clicking on the form saved to your workstation, an initial screen will warn you that various connection tests will take place when you start the form. If any of these tests fail, it is most likely because of improper security settings.
Save two versions of your form The NHPD recommends applicants save a copy of their ePLA prior to finalizing the form. This allows applicants to use the form as a template if they have similar products they wish to use, or if they need to make modifications to a refused file. The "Modify" button in the ePLA should neverbe used to prepare a new application as this will result in a duplicate tracking number which can severely slow the processing of an application.
After successfully completing Part 1; Before starting Part 4; After selecting a monograph in Part 4 Check for all potential errors before proceeding
NOTE: For all NHPD
forms, required information fields are indicated by an * after the field label. Become familiar beforehand with monographs you may wish to invoke
Before selecting an ingredient from a monograph in the ePLA, be sure to review the attributes of the monograph beforehand to understand any limitations on dosage forms, conditions of use, and especially dosage ranges. Please note that all monographs are found in the NHPID and that each ingredient that has a monograph is linked to the monograph in the NHPID's ingredient entry. You may find that another monograph more closely meets your needs or that no monograph supports the specifics of your product.
NOTE: This recommendation may be especially relevant for Homeopathic application types. 3.0 Natural health electronic Product Licence Application form
Before using the electronic application form, it is very important to become familiar with the application types for natural health products (see the Product Licensing guidance document).
The ePLA Form is divided into five parts which are completed progressively. When Part 1 is completed, Part 2 is displayed and so on (see Figure 1 below.) A Part is completed successfully when the "Continue" button is selected and no errors are found. The "Continue" button then transforms into a "Modify Form" button, and the completed Part is locked to prevent further changes and the next Part is displayed.
NOTE: Certain changes - such as returning to change the Type of Application in Part 2 after having begun to complete Part 4 - can have a major impact on any information already captured in Part 4. Because the form may not behave as intended, applicants should not go back and change the application type. The ePLA Form may be saved at any time on the workstation and resumed at a later time.
TIP: The ingredients found in your product, both medicinal and non-medicinal, must be indicated as such in the Natural Health Products Ingredient Database prior to completing the ePLa. Figure 1: Progressive Assembly of an ePLA This image shows a multi-part side-by-side progressive assembly of the ePLA Form that will be displayed during the online application process and for post-licence updates. When Part 1 is completed, Part 2 is displayed and so on. Depending on the information captured in Part 4, an additional subform named the Animal Tissue Form (ATF) may be appended automatically to the ePLA. After completion of Part 5, an Attestation section appears before a Finalize button does. Back For more information on completing Part 1 – Applicant and Contact Information, refer to Section 3.2 For more information on completing Part 2 – Application Type, refer to Section 3.3 For more information on completing Part 3 – Site Information, refer to Section 3.4 For more information on completing Part 4 – Product Information, refer to Section 3.5 For more information on completing Part 4 – Product Information for non-homeopathic applications, refer to Section 3.5.2 For more information on completing Part 4 – Product Information for homeopathic applications, refer to Section 3.5.3 For more information on completing Part 5 – Label Text, refer to Section 3.6 For more information on completing the Animal Tissue Form, refer to Section 3.7
For more information on finalizing the Product Licence Application, refer to Section 3.8 For more information on using the ePLA form after its submission, refer to Section 4
Figure 2: Applicant or Licensee Information This figure is a snapshot of the Applicant or Licensee Information. The figure consists of 9 segments. From top to bottom and left to right, the first segment has the text ‘PART 1 – Applicant or Licensee Information’. Next segment below contains the text ‘A. – APPLICANT OR LICENSEE (This is the product licence holder)’. Below this, there are 2 segments. The one on the left hand side contains the text ‘4. Applicant/Company Name*’ and the right hand side is the segment with the text ‘5. Company Code (if known)’. Below this is a segment with the text ‘6. Address: Street/Suite/Land Location*’. Below this are four segments. For left to right, the segments have the text ‘7. City-Town*’, ‘8. Country*’ with a dropdown menu button, ‘9. Province-State *’ with a dropdown menu button, ’10. Postal/ZIP Code*’ Back Block A is to capture information about the company in whose name the Natural Health Product application is submitted and the product licence is to be registered (the applicant will be referred to as the licensee once a licence has been granted).
Figure 3: Senior Official Information This figure is a snapshot of the Senior Official Information. The figure consists of 16 segments in total. Back A senior official must always be designated for the applicant company. The principal contact person for the licensee/applicant, at the address given, is the person to whom regulatory mail is sent. This is not the contact person for submission-specific questions, but the person who has the authority to represent the company.
Figure 4: Contact for this Application Information This figure is a snapshot of the Contact for this Application Information. The figure consists of 18 segments. From top to bottom and left to right, the first segment has the text ‘C.-CONTACT FOR THIS APPLICATION (This is the contact person for product-specific questions) followed by an ‘Add a Contact’ button. Below this, there is one segment with the text ’24.Contact same as Senior Official’ with a dropdown menu button. Below this, there are 4 segments. The texts are ’25.Name*’ with a dropdown menu button, ‘Surname*’, ‘Given Name*’, ’26.Title’, and ’27.Language preferred:*’ with a dropdown menu button. Below this, there are 2 segments. The texts are ‘28.Company Name (*if different from Applicant/Licensee)*’ and ’29.Address same as Applicant/Licensee’ with a dropdown menu button for the latter. Below this, there is 1 segment with the text ’30.Street/Suite/PO Box*’. Below this, there are 4 segments with the texts ’31.City-Town*’, ’32.Country*’ with a dropdown menu button, ’33.Province-State*’ with a dropdown menu button, and ‘34.Postal/ZIP Code*’. Below this, there are 4 segments with the texts ’35.Telephone No.*’, ‘Ext.’, ’36.Fax No.*’, and ’37.E-mail*’. Back The contact for this application is the person to whom the NHPD will direct submission-specific questions. This may be an employee of the licensee/applicant, or an individual contracted from another company on behalf of the licensee/applicant (3rd party consultant). There may be more than one contact indicated per application. Additional contacts may be added by selecting the "Add a Contact" button.
Figure 5: Representative in Canada Information This figure is a snapshot of the Representative in Canada Information. The figure consists of 16 segments. From top to bottom and left to right, the first segment has the text ‘D.-REPRESENTATIVE IN CANADA (Only required where Address in “A” is not in Canada). Below this, there is one segment with the text ’38.Representative in Canada same as Contact’ with a dropdown menu button. Back The Representative in Canada block will be shown and is mandatory only if the Country indicated in the licensee/applicant's address (Block A) is not "Canada".
TIP: At this point, you may find it useful to save a version of the ePLA
with a completed Part 1, which you can then reuse whenever you need to start a new application. 3.3 Application type (Part 2)
The available types of application are as listed below and shown in Figure 6:
Compendial NHPD Labelling Standard - Homeopathic Medicine Labelling Standard (HMLS) Homeopathic Medicine with Specific Claim Homeopathic medicine with Non-Specific Claim Non-Traditional TPD Category IV/Labelling Standard Traditional Figure 6: Example of Type of Application This figure is a snapshot of an Example of Type of Application. From top to bottom, the first segment has the text ‘PART 2 – APPLICATION TYPE’. Below this, there is a segment with the text ‘A. PRODUCT LICENCE APPLICATION’. Below this, there is a segment with the text ’53. Type of Application*’. This segment has a dropdown menu button. In this example, the dropdown menu options are visible, from top to bottom, with the texts ‘Compendial’, ‘NHPD Labelling Standard – Homeopathic Medicine Labelling Standard (HMLS)’, ‘Homeopathic Medicine with Specific Claim’, ‘Homeopathic Medicine with Non-Specific Claim’, ‘Non-Traditional’, ‘TPD Category IV / Labelling Standard’, and ‘Traditional’. Back Reference submission (Block 'B')
The Reference Submission block header is shown for all application types except for Compendial applications. To see the full block, click on the "Add a Reference" button. Where related submissions are referenced in the subject submission, provide the company code of the applicant/licensee of the reference submission, the file number, the submission number, and the NPN/DIN-HM number (if available). 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.
Figure 7: Reference submission information This figure is a snapshot of the Reference Submission Information. The figure consists of 9 segments. From top to bottom and right to left. The first segment contains the text ‘F.-REFERNCE SUBMISSION’. At the far right, an ‘Add a Reference’ button is found. The next segment below has the text ’60. Other Supporting Submission’. At the far right a ‘remove’ button is found. Below, there are 4 segments with the text ‘60a. Company Code’, ‘60b. File Number*’, ‘60c. Submission Number*’, and ‘60d. NPN/DIN-HM number’. Below this, there are 3 segments with the texts ‘60e. Contains Information to Support’ along with 3 check boxes underneath labelled ‘Safety’, ‘Efficacy’, and ‘Quality’; ‘60f. Letter of Access Enclosed*’ with a dropdown menu button; and the last segment is empty. Back Should an applicant wish to reference more than one submission, selecting the "Add a Reference" button displays another Block F. Any of these blocks can be removed by clicking on the "Remove Supporting Submission" button.
NHPD master file (Block 'C')
The NHPD Master File block header is always shown. To see the full block, click on the "Add Master File Reference" button. 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.].
Figure 8: Master File Information This figure is a snapshot of the Master File Information. This figure consists of 5 segments. From top to bottom and right to left, the first segment contains the text’G. –NHPD MASTER FILE’ with an ‘Add a Master File’ button on the far right. The next segment below has the text ’61.Supporting Master File’ along with a ‘remove’ button on the far right. Below, there are 3 segments. The first segment has the text ‘61a.Master File Number*’. The second segment has the text’61b. Contains information to support*’ along with 4 check boxes with the texts ‘61e. Quality only’, ‘61c. Safety only’, ‘61d. Efficacy only’, and ‘61f. Complete submission’. The last segment has the text ‘61g.Letter of Access Enclosed*’ along with a dropdown menu button. Back Should an applicant wish to reference more than one NHPD Master File, selecting the "Add Master File Reference" button displays another Block G. Any of these blocks can be removed by clicking on the "Remove Supporting Master File" button.
Figure 9: Site Information This figure is a snapshot of the Site Information. This figure consists of 15 segments. From top to bottom and right to left, the first segment contains the text ‘PART3 – SITE INFORMATION’ along with an ‘Add a Site’ button on the far right. The next segment below contains a ‘remove’ button on the far right. Below, there is a segment with the text ’62.Company Name’. Below, there is a segment with the text ’64.Number, Street – Suite –PO Box’. Below, there are 4 segments. They contain the text ’65.City’, ’66.County’ along with a dropdown menu button, ’67. Province-State’ along with dropdown button, and ’68.Postal code – Zip Code’. Below, there are 7 segments. The first segment contains the text ’63. Site Activity Type’. Underneath this segment there are 5 sub-segments, all with a dropdown menu button and contain the texts ’63a.Manufacturer’, ‘63b. Packager’, ‘63c. labeller’, ‘64d. Importer’, and ‘63e.Distributor’. On the right of the sub-segments, there is a segment with the text ’69. Site Licence Number’. Back 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 NHPD can also be provided.
Additional Sites blocks can be added by selecting the "Add a Site" button. Any of these blocks can be removed by clicking on the "Remove Site" button.
Tip: Before beginning to capture information in Part 4, always make a point of saving the ePLA form with a unique name, closing it and then opening it again. This establishes a reference copy of the form that can be reused should you wish to no longer continue with information entered later (example: you decide to use a different monograph or to change the method of preparation). The ePLA dynamically connects with the Natural Health Products Ingredients Database (NHPID) to obtain information related to standard terminologies for natural health products such as medicinal and non-medicinal ingredients, dosage forms, routes of administration, and units. The Natural Health Products Ingredients Database information on monographs is also accessed when applicable.
Table 1 - Types of ePLA applications Type(s) of application
Compendial (NHPD Monograph) Single Ingredient and Product Monographs Medicinal Ingredient Name Free text (consistent with the chosen monograph) Traditional Non-traditional Medicinal Ingredients Medicinal Ingredient Name Free text TPD Category IV / Labelling Standard TPD cateogry IV Monographs and labelling standards Medicinal Ingredient Name Free text NHPD Labelling Standard - Homeopathic Medicine Labelling Standard (HMLS) Homeopathic Ingredients Homeopathic Ingredient Name Pre-determined list of four general claims Homeopathic Medicine with Specific Claim Homeopathic Ingredients Homeopathic Ingredient Name Free text Homeopathic Medicine with Non-Specific Claim Homeopathic Ingredients Homeopathic Ingredient Name Pre-determined list of four general claims TIP: Adding information to the NHPID
For updates to or additions of medicinal ingredients, non-medicinal ingredients or controlled vocabulary (such as dosage form, units of measurement or NMI purposes) , a separate form, the Natural Health Product Ingredients Database Issue Form
must be used. 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 Issue forms are to be sent to ingredient_support@hc-sc.gc.ca
for review and inclusion in the NHPID. 3.5.2 Non-homeopathic applications
The following application types are non-homeopathic:
Compendial Non-traditional; Traditional; and TPD Category IV/Labelling Standard. Step 1: Heading
Figure 10: Heading for Product Information This figure is a snapshot of the Heading for Product Information. This figure consists of 6 segments. From top to bottom and right to left, the first segment contains the text ‘PART4 – PRODUCT INFORMAITON’. Next segment below has the text ’70. Primary Brand Name*’. Below, there is a segment with the text ’71.Other Brand Names’ along with two buttons on the far right labelled ‘Add Brand Name’ and ‘remove’; the latter is below the former. Below, there are 3 segments with the texts ‘105.Route of Administration*’ along with a dropdown menu button, ‘103. Dosage Form (one only)*’ along with a dropdown menu button, and ‘104. Sterile*’ along with two centred radio buttons with the text ’Yes’ and ‘No’, respectively. Back Primary brand name: Free text. Can be entered either here or on the first page above Part 1 and will be updated in both locations.
TIP : Enter one brand name per line Sterile: When the application type is Compendial, the sterility condition is set to 'No' and the Sterile field is locked. For the other application types in this section, when the route of administration is chosen as 'Ophthalmic', the sterility condition is set to 'Yes' and the Sterile field is locked. For all other situations, the sterility condition is a choice of 'Yes' or 'No'.
TIP : Acceptable synonyms for dosage forms can be found in the NHPID; synonyms can be used on the marketed label. Step 2: Block 'A' - Medicinal ingredients
TIP: Before beginning to capture information in Part 4, research the ingredients of your product first in the NHPID
to: Ensure the ingredient already exists in the NHPID. Know which ingredient to select when filling out the ePLA as some ingredients may appear to be the same but have differences in constituents, extract information, methods of preparation, etc... After selecting an ingredient, some fields will be automatically pre-populated based on information found in the Natural Health Products Ingredients Database. If the required ingredient information cannot be found in the Natural Health Products Ingredients Database, the applicant can request that the information be added formally through the Natural Health Products Ingredients Database Issue process (see Natural Health Products Ingredients Database Issue Form User Manual.)
Removing ingredients: Ingredients can be removed from the application by selecting the "remove" button as shown below.
Figure 11: Remove an existing Medicinal Ingredient This figure is a snapshot of the Removing and existing Medicinal Ingredient. This figure consists of 14 segments. From top to bottom and right to left, the first segment contains the text ‘A. MEDICINAL INGREDIENT(S)’ and an ‘Add an Ingredient’ button is found at the far right. Below, there is a segment with the text ‘MI 1: Aloe vera’ and a ‘remove’ button on the far right. Aloe vera is the example used here. Below, there are two segments with the texts ’75. Proper Name* Aloe vera’ and ‘Common Name*’. Aloe vera is used as an example here. Both former and latter segments have dropdown menu buttons. Below, there are 4 segments with the texts ’73.Standard or Grade’ along with a dropdown menu button; ‘Ingredient Type* Organism’ with organism used as an example; ‘77a. Quantity per Dosage Unit*’ and ‘77b. Unit of Measure*’ with a dropdown menu button. Below, there are 4 segments with the texts ’79. Animal Tissue**’ beneath which two ration button labelled ‘Yes’ and ‘NO’; ‘Synthetic*’ beneath which two radio buttons labelled ‘Yes’ and ‘No’; ‘Additional Quantity’; and ‘Additional Unit’ with a dropdown menu. Below, there is a segments with the text ‘Source Material(s)*’ along with a dropdown menu and and ‘Add a Source Material’ text, both on the far right side. Below, there is a segments with the text ‘Method(s) of Preparation*’ and a dropdown menu on the far right side. Back Adding ingredients: The ePLA shows one empty medicinal ingredient sub-block to start because at least one medicinal ingredient is required to successfully finalize the form. More ingredients can be added to the application by selecting the "Add an Ingredient" button. This will create a new empty ingredient sub-block.
Figure 12: New (empty) Ingredient This figure is a snap shot of New (empty) Ingredient. This figure consists of 2 segments. The first segment contains the text ‘A. MEDICAL INGREDIENT(S)’ and an ‘Add an Ingredient’ button on the far right. The next segment below contains the text ‘MI 1’, then a centred ‘Search Ingredients Database’ button, then a ‘remove’ button on the far right. Back Searching the ingredients database
NHPID name; Proper names; Common names; Synonym; Taxonomical synonyms (Taxa); and Chemical Abstracts Service(CAS) numbers Selecting the "Search Ingredient Database" button invokes the search tool. To search for an ingredient, enter a keyword and click Search. A message indicating the number of results will appear before the search result page is displayed. When an ingredient has an associated monograph or abbreviated labelling standard, this is indicated in the search result as pre-cleared information. (See Figure 13 for an example of a successful ingredient search result).
Figure 13: Example of a Successful Ingredient Search Result This image displays a portion of the Natural Health Products Ingredients Database search tool. The top segment includes five radio buttons named Chemical, Protein, Organism, Defined Organism Substance, and Any. The Organism radio button is checked. Beside it is an entry field entitled 'Keyword' in which is typed 'Aloe'. Below it is a button named Search. In the top-right hand corner is a smaller 'Close' button. The bottom section displays information on five ingredients, which are Agave Americana, Aloe arborescens, Aloe ferox, Aloe vera, and Aquilaria malaccensis. Below each ingredient is a list of one or more common names. Below ingredient Aloe vera there are also links to pre-cleared information. To the right of each ingredient is a 'More Details' link. Above the list of ingredients, text states 'Please click on an ingredient name to add the ingredient to the form' and 'Page 1 Results per page 20 Total 6'. Back Selecting a filter: The search engine has a default of all ingredient types; however, 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.
Conducting a search: Select the Search button to start searching. Searching can also be triggered by depressing the <Enter> key. For applications of type Non-traditional, Traditional and TPD Category IV/Labelling Standard, the entire set of non-homeopathic medicinal ingredients of the NHPID is searched. For applications of type Compendial, only those ingredients present in non-homeopathic NHPD single ingredient and product monographs are searched. Search results are presented in alphabetical order of NHPID name.
Getting detailed information of an entry: Selecting the hyperlink " More Details" on the right shows the detailed information of the ingredient found in the NHPID through the Web browser.
Selecting an entry: Selecting the hyperlinked ingredient name on the left fills the related fields in the ePLA.
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. An example of a search result is shown above in Figure 13: Example of a Successful Ingredient Search Result . If you are experiencing difficulty finding ingredients through the search function of the ePLA, it is best to fully explore the ingredient using the NHPID.
When a search fails under the Compendial application type, it likely means that the ingredient does not appear in a non-homeopathic NHPD monograph. An application type other than Compendial must be considered.
TIP: Please note that 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 NHPD (see Natural Health Products Ingredients Database Issue Form Guide
) to request that the missing information be added to the database. Presentation of medicinal ingredients
Figure 14: Ingredient names This figure is a snapshot of the Ingredient Names. This figure consists of 2 segments. The first segment on the right contains the text ’75. Proper Name*’ with a dropdown menu button on the far right of the segment. The next segment on the right contains the text’ Common Name*’ with a drop down menu button on the far right. Back However, since the data for different ingredient types varies, the completed fields of Block 'A' capture different information to reflect the requirements of each specific ingredient.
Basic information There are 8 fields in this part as shown in the figure below.
Figure 15: Basic Information of the Ingredient This figure is a snapshot of the Basic Information of the Ingredient. This figure consists of 8 segments. From top to bottom and right to left, the first segment contains the text ’73. Standard or Grade’ with a dropdown menu button on the right. Next segement, on the right, has the text ‘Ingredient Type*’. The third segment has the text ’77.Quantity per Dosage Unit*’. The fourth segment contains the text ‘77b. Unit of Measure’ with a dropdown menu button on the right. Below, there is a segment with the text ’79. Animal Tissue**’ with two radio buttons underneath, ‘Yes’ and ‘No’, respectively. Next segment on the right has the text ‘Synthetic*’ with two radio buttons underneath, ‘Yes’ and ‘No’, respectively. Next segment on the right contains the text ‘Additional Quantity’. The next segment on the right contains the text ‘Additional Unit’ with a dropdown menu button on the right. Back 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 NHPD. The Standard or Grade is not a required field.
Source ingredients: From the pick list select the ingredient source from which the ingredient was isolated. (See Figure 16 .). To capture more than one source, click the "Add a Source Ingredient" button. Source materials are a combination of an organism and an organism part. For ingredients having both Source ingredients and Source Materials, there must be a selection from at least one of the two fields
Figure 16: Source ingredient This figure is a snapshot of the Source Ingredient. This figure has one segment with the text ‘Source*’ and an ‘Add a Source’ button on the far right with a dropdown menu button underneath the latter. Back Source material: Select the Source Material from the pick list provided, if applicable. (see Figure 17.) 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 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 Materials, there must be a selection from at least one of the two fields.
Figure 17: Source Material This figure is a snapshot of the Source Material. This figure has one segment with the text ‘Source Material(s)*’ and an ‘Add a Source Material’ button on the far right with a dropdown Menu button underneath the latter. Back For probiotics and bacteria, an extra field entitled 'Strain' is provided to enter the bacterial strain number. This field is mandatory for probiotics and non-mandatory for bacteria.
Figure 18: Source Material and Strain This figure is a snapshot of the Source Material and Strain. This figure has one segment with the text ‘Source Material(s)*’ and an ‘Add a Source Material’ button on the far right. Underneath the latter there is a dropdown menu button followed by the text ‘Strain:*’. Back Method(s) of preparation: The preparation method used for the ingredient is required only for organism and organism substance types. A long pick list of methods of preparation is populated for ingredients of Organism type and a short list for ingredients of Defined Organism Substance type. Detailed information on the NHPD methods of preparations can be found in the Natural Health Products Online System Standard Terminology User Manual.
Figure 19: Methods of Preparation This figure is a snapshot of the Methods of Preparation. This figure has one segment with the text ‘Method(s) of Preparation*’ with a dropdown menu button on the far right. Back Potency: The concentration of the active or marker constituents of an ingredient is required only for ingredients of Defined Organism Substance type when the method of preparation is standardized (see the Natural Health Products Online System Standard Terminology User Manual.) Three fields are required for potency: constituent (name), quantity, and unit (see Figure 20). The NHPD has been capturing acceptable constituent data for natural substances. If constituent data is available for a particular organism part, a pick list of constituents will be pre-populated. In the case where the constituent cannot be found in the list or no populated list is available, then the applicant can request that the information be added formally through the Natural Health Products Ingredients Database Issue process (see the Natural Health Products Ingredients Database Issue Form User Manual - see Adding Information to NHPID above).
To capture more constituents, click on the "Add a Subingredient" button.
Figure 20: Potency This is figure is a snapshot of the Potency. This figure contains 4 segments. From top to bottom and right to left, the first segment contains the text ‘Potency’ with an ‘Add a Constituent’ button on the far right. Below there are 3 segments. The first has the text ‘Constituent*’ with a dropdown menu button on the right. Next segment has the text ‘Amount*’. Next segement has the text ‘Unit*’ with a dropdown menu button on the right. Back Extracts and solvents: The detailed information about processing organism ingredients is required only for organism-type ingredients (see Figure 21). The required fields are determined according to the method of preparation selected. 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.
Figure 21: Extracts and Solvents This figure is a snapshot of the Extracts and Solvents. This figure contains 8 segments. From top to bottom and right to left, the first segment has the text ‘Extract’. Below, there are 4 segments with the texts ‘Ratio*’ with ‘1: ‘; ‘Quantity Crude Equivalent*’ ; ‘Unit*’ along with a dropdown menu button on the right; and ‘Original Material Used*’ along with a dropdown menu button on the right. Below, there is one segment with the text ‘Solvents’ with an ‘Add a Solvent’ button on the far right. Below there are 2 segments with the texts ‘Solvent’ and a dropdown menu button on the right. Next segment has the text ‘Solvent Strenght’. Back Ratio: Ratio of the quantity (usually weight) of raw material used to the quantity (weight or volume) of final preparation. The ePLA 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.
TIP: If the solvent appears in the finished product, it must also be indicated in the Non-medicinal ingredient section of the ePLA. Solvent strength: Numeric value (%) is required. More detailed information can be found in the Natural Health Products Online System Standard Terminology User Manual.
Subingredient: When an ingredient is defined with subingredients in the NHPID (for example, Calcium phosphate monobasic has Calcium and Phosphorus as sub-ingredients), the Subingredient component is displayed as shown in Figure 22. To capture more subingredients, click on the "Add a Sub-ingredient" button.
Figure 22: Subingredient This figure is a snapshot of the Subingredient. This figure contains 5 segments. From top to bottom and left to right, the first segment has the text ‘Subingredient’ along with an ‘Add a Subingredient’ button on the far right. Below, there are 4 segments with the text ‘Constituent*’ along with a dropdown menu button on the right; ‘Amount*’; ‘Unit*’ with ‘Percent’ underneath along with a dropdown menu button on the right; and a ‘remove’ button. Back Step 3: Block 'B' - 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 of the NHPID is searched.
Figure 23: Non-medicinal Ingredient Information This figure is a snapshot of the Non-medicinal Ingredient Information. This figure contains 10 segments. From top to bottom and left to right, the first segment contains the text ‘B.NON-MEDICINAL INGREDIENT(S)’ with an ‘Add a Non-Medicinal Ingredient’ button on the far right. Below, there is a segment with the text ‘NMI 1:’ with a centred ‘Search Ingredient Database’ button and a ‘remove’ button on the far right. Below, there are 4 segments with the texts ’98.Standard or Grade’; ’94.Common Name*’ along with a dropdown button on the right; ‘99a. Quantity per Dosage Unit’; and ‘99b. Unit of Measure’. Below, there are 3 segments with the texts ‘95. Purpose*’; (empty segment); and ’96. Animal Tissue**’ with two radio buttons underneath with the text ‘Yes’ and ‘No’, consecutively. Back Standard or grade: Pharmacopoeia or other grade or standard with which the ingredient will comply. The pick list of standards and grades represents pharmacopoeial grades acceptable to the NHPD. This field is not required and only needs to be completed as required or if applicable to the ingredient.
As shown below in Figure 24, 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, check "Yes" and fill out the Animal Tissue Form at the end of this form; otherwise check "No".
Figure 24: Ingredient(s) Used in Processing This figure is a snapshot of Ingredient(s) Used in Processing. This figure contains 2 segments. The first segment has the text ‘C.INGREDIENT(S) USED IN PROCESSING’. Below, the next segment has the text ‘101. “Was animal tissue used in the processing of this product, although no present in the final product?”**’ along with 2 radio buttons with the texts ‘Yes’ and ‘No’, consecutively. Back Step 5: Block 'D' - Recommended conditions of use
Recommended use or purpose; Recommended dosage, including directions of use for each sub-population group; Duration statement(s); and Risk information. Recommended use(s) or purpose: Provide at least one statement in free form text in the area shown below in Figure 25. At least one use or purpose statement must be indicated. If using more than one use/purpose, please indicate these individually, i.e. on separate lines. To add another statement, click on the "Add a Statement" button.
Figure 25: Recommended Use(s) or Purpose This figure is a snapshot of the Recommended Use(s) or Purpose. This figure contains 3 segments. The first segment has the text’D.- RECOMMENDED CONDITIONS OF USE’. Below, the segment contains the text ‘102. Recommended Use(s) or Purpose’ along with an ‘Add a Statement’ button on the far right. Below, the segment contains a dropdown menu button on the far right along with a ‘remove’ button on the right of the latter. Back TIP: In certain instances, you may find that the text of your Recommended Use(s) or Purpose exceeds the limit (shown by a plus sign - + - at the end) Should that happen, it is suggested that you add another statement line in order to continue with the text. This ensures that all text will be clear and visible should you intend to print the ePLA at a later time. Recommended dose
Recommended Dose is required for all products. One set of information is captured for each sub-population group as shown below.
Figure 26: Recommended Dose This figure is a snapshot of the Recommended Dose. This figure contains 13 segments. From to top to bottom and left to right, the first segment has the text ‘Recommended Dose (repeat for each sub-population group)’ with an ‘Add a New Sub-Population & Recommended Dose’ on the far right. Below, the next segment has the text ‘Sub-population 1’ with a ‘remove’ button on the far right. Below, the next segment has the text ‘107. Sub-population group’ with a dropdown menu button on the far right. Below, the first segment has the text ’Dosage’ along with two sub-segments underneath with the texts ‘Min-Max’ for the first and ‘110. Dosage units’ for the second along with a dropdown menu button on the right. On the right, there is a segment with the text ‘Frequency’ with 2 sub-segments underneath with the texts ‘Min-Max’ for the first and ‘Frequency Units* day’ for the second along with a dropdown menu button. On the right, there is a segment with the text ‘Additional Dosage Information (ex. 1 scoop=30g). Below, there is a segment with the text ‘112. Directions of Use’. Below, there is a segment with the text ‘106.Duration Statement’ with an ‘Add a Statement’ button on the far right. Back Sub-population group: Either select one of the provided sub-population groups or enter your own subpopulation, including age range, by replacing "---Text Entry". If more than one sub-population group is required, click on the "Add a New Sub-Population & Recommended Dose" button to generate a new recommended dose block.
TIP: If dose is 1 capsule 1x/day, enter '1' in the min and max fields for dosage and frequency. Additional dosage information: Optional free text.
Figure 27: Duration Statement This figure is a snapshot of the Duration Statement. This figure contains 2 segments. The first segment has the text ‘106. Duration Statement’ along with an ‘Add a Statement’ button. Below, the next segment has a ‘remove’ button on the far right Back Risk information:
As shown in Figure 28 below, risk information consists of:
Cautions and warnings; Contraindications; and Known adverse reactions. All are optional free text. If additional statements are desired, click on the "Add a Statement" button.
Figure 28: Risk Information This figure is a snapshot of the Risk Information. Back Step 6: Block 'E' - Nanomaterial ingredients
Figure 29: Nanomaterial Ingredients Information This figure is a snapshot of the Nanomaterial ingredients part E. It asks the question: Does this product contain any ingredients (medicinal or non-medicinal) that would be considered nanomaterials. A “yes” or “no” response is required to the nanomaterial ingredients question. If the answer is “yes”, the list of nanomaterial ingredients is required to be completed in the field below. Back Step 7: Block 'F' - Animal Tissue Form
Block 'F' contains a "Go to the Animal Tissue Form" button that will take you to the first animal tissue form. All animal tissue forms must be completed before you can validate the form.
After the information has been entered, click on the "Continue" button to validate the content of Part 4.
For more information on meeting requirements in an ePLA, refer to the Product Licensing guidance document
. 3.5.3 Homeopathic applications
Three types of homeopathic applications (NHPD Labelling Standard - Homeopathic Medicine Labelling Standard (HMLS), Homeopathic Medicine with Specific Claim, and Homeopathic Medicine with Non-Specific Claim) can be selected in Part 2 from the field entitled 'Application Type'. When one of those application types is selected, Part 4 of the form takes on a look that's different from the other application types because homeopathic applications have different medicinal ingredient information requirements. All homeopathic applications have attestation statements that must be accepted for successful validation. The following figures distinguish the attestation statements for the three types.
Figure 30: Homeopathic Medicine Labelling Standard (HMLS) Attestations This figure is a snapshot of the Cfgm Heading. This figure contains 8 segments. From top to bottom and left to right, the first segment has the text ‘PART4 – PRODUCT INFORMATION’. Below, the next segment has the text ’70. Primary Brand Name*’. Below, the next segment has the text ’71. Other Brand Names’ with an ‘Add Brand Name’ button on the far right with a ‘remove’ button beneath the latter. Below, the next segment has the text ‘Monograph Name’ with a centred ‘Search Monograph Database’ button. On the right, there is a segment with the text ‘Monograph Date’. Below, there are 3 segments. They have the text ‘105. Route of Administration*’; ‘103. Dosage Form (one only)*’; and ‘104. Sterile*’ with 2 radio buttons underneath, ‘Yes’ and ‘No’. As an example, the ‘No’ radio button is selected. Back Figure 31: Homeopathic Specific Attestations This figure is a snapshot of the monograph search tool. It contains 3 fragments. From the top to the bottom and left to right, the first fragment contains a box to enter the keywords to perform the search. Below the search box, to the left the search button is located. In the last fragment located below the search buttons are the displayed results from the search. Back Figure 32: Homeopathic Non-Specific Attestations This figure is a snapshot of the medicinal ingredients portion of the form under part A. It contains 9 segments. From top to bottom and left to right. In first field 75.a* ‘Proper Name’ giving choices in a drop down menu, to the right of this segment, it has the entry ‘Common Name*’ with also a drop down menu. In segment 73 a required entry is the ‘Standard or Grade ‘with a drop down menu. To the right of this segment can be found the ‘Ingredient Type*’, with the text entry “Defined Organism Substance”. Right of this segment 77a. Quantity must be entered per dosage unit. At the right of this segment there is the unit of measure. Below, to the left of this level is 79. Animal tissue** segment that provides, two radio buttons that are a “Yes” and a “No”. At the right of this segment, the box asks if the ingredient is synthetic with two radio button that are a “Yes” and a “No”. At the right of this segment, the box asks if there is additional quantity or additional units. On the level below, Source material(s)* are required with the text entry Angelica Archangelica – Leaf, with a drop down menu. In this field there is the option to Add a source material by clicking the ‘Add a Source Material’ at the left of the box. Below this segment can be found the Methods of Preparation * with a selectable drop down menu. Back As with other non-compendial applications, a homeopathic application search is performed on the ingredients. However, in this instance, the search is solely on 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).
Conducting a search: Select the "Search" button to start searching. Searching can also be triggered by depressing the <Enter> key. A message indicating the number of results will appear before the search result page is displayed.
Figure 33: Example of a Homeopathic Ingredient Search Result This figure is a snapshot of Block ‘D’ for compendial from generated monograph application. It contains 2 fragments. From top to bottom and left to right, the first segment refers to 102. the recommended use(s) or purpose. To the right of this segment appears the button ‘Add a statement’. Directly below a drop down menu provides examples of recommended uses such as: “Provides antioxidants for the maintenance of good health”. The second segment refers to the recommended dose which is detailed in the following Figures. Back Results are displayed in alphabetical order of NHPID name.
Spelling errors including the presence or absence of accents; 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. After finding an ingredient, as seen in Figure 34 below, the following fields will be pre-filled from the Ingredients Database: Standard or Grade, Proper Name, Common Name, Synthetic, Animal Tissue Used, Source Information, Method of preparation and whether animal tissue was used in processing the ingredient. 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 ePLA.
The form allows for substitution of Source Information and Method of Preparation information pre-filled from the database by replacing the '---Text Entry' selection with freeform text.
Figure 34: Successful Ingredient Selection for Homeopathic Application This figure is a snapshot of the medicinal ingredients portion of the form under part A. It contains 9 segments. From top to bottom and left to right. In first field 75.a* the form asks for the ‘Proper Name’ giving choices in a drop down menu, to the right of this segment, it has the entry ‘Common Name*’ with also a drop down menu. In segment 73 a required entry is the Standard or Grade with a drop down menu. Right of this segment can be found the ingredient type*, with the text entry “Defined Organism Substance”. Right of this segment the ‘77a. Quantity’ must be entered per dosage unit. At the right of this segment there is ‘77.b unit of measure’. Below, to the left of this level is 79. ‘Animal tissue**’ segment that provides, two radio buttons that are a “Yes” and a “No”. At the right of this segment, the box asks if the ingredient is synthetic with two radio button that are a “Yes” and a “No”. At the right of this segment, the box asks if there is additional quantity or additional units. On the level below, Source material(s)* are required with the text entry Vaccinium myrtillus I – Fruit with a drop down menu. In this field there is the option to Add a source material by clicking the add a source material at the left of the box. Below this segment can be found the Methods of Preparation * with a selectable drop down menu. Back A brief explanation is provided for fields that are unique to homeopathic applications.
3.5.4 Applications with non-oral routes of administration
Filling in an ePLA with a route of administration other than 'Oral' can sometimes prove challenging. When either 'Buccal' or 'Topical' is chosen as the route of administration, the form validation will behave differently as the dosage and frequency fields of the Recommended Dose section will no longer be mandatory as long as a directions for use is entered. An example from a Compendial application type is given to illustrate. A topical Fenugreek cream with 50 grams of powdered seed and which meets the Fenugreek monograph will appear in the ePLA as shown below.
Figure 35: Example of topical product - Part 4A This figure is a snapshot of Dosage Unit Selection Resulting from Dosage Form Selection, containing 10 segments. From top to bottom and left to right the first field is 107. Sub-population group* with a example text entry “Adults”. Directly below the next segment refers to dosage with the text ‘Min.* and Max.*’. To the right, there is segment 110. Dosage Units* with a dropdown menu with the choices: Teaspoon(s), Tablespoon(s), Dropper(s), Drops, Millilitre(s). The next segment to the right is Frequency with the text entry ‘Min* and Max* (times a)’ to the right Frequency Units*/ day with a drop down menu. The next segment located to the right is ‘Additional Dosage Information (ex. 1 scoop = 30g)’. The next segment below from left to right is 112. Direction of Use. To the right is ‘Additional Directions of Use’. Below is ‘106. Duration Statement’. Below Risk information is found with the segment ‘113. Cautions and Warnings’ with the possibility to ‘Add an Statemen’t with the button to the left of this segment. Back Similarly, if the product is an extract, a method of preparation of 'Extract dry' is selected and the quantity of 50 grams is entered in the Quantity Crude Equivalent field. Based on the extract ratio, the appropriate quantity is input in the quantity per dosage unit fields.
Figure 36: Example of a Topical product - Part D This figure is a snapshot of a Microsoft Error Notification pop-up with the title Warning: JavaScript Window – and the text entry: “The recommended dosage entered is less than the permitted minimum daily amount. Dosage limit: 1.8 Actual 1.50000”. Below this text entry to the left is the button “OK” Back 3.6 Label text (Part 5)
The initial version of the generated label text is assembled from the information entered in the ePLA. The applicant is then able to review this initial version and to provide clarifying and additional information as appropriate. The content is organized by panel as per Section 93 of the Natural Health Products Regulations and published in the Labelling Guidance Document. At any time, the applicant can select the "View" button to view the finished results. Once the finished results are satisfactory, the applicant validates the label text by selecting the "Validate" button. 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 ePLA.
Principal Display Panel; Any Panel; Outer Label Text Only; Security Package; and Specialized Labelling - Inner and/or Outer. Each section contains one or more subsections. A section or subsection can be displayed or hidden by selecting in the corresponding "Hide" checkbox. The field values displayed in the sections/subsections are from Parts 1, 3, and 4 of the ePLA. Mandatory fields are identified with an asterisk (*). Some field values may be replaced for label text purposes by entering a new value in the corresponding "Replace with a statement to the effect of:" field, while other field values can be included on (or removed from) the label text by selecting in the corresponding "Include on Label "checkbox.
Front panel: In the Front Panel section, shown in Figure 37: Front Panel Section below, 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, the users can input their own container units.
Figure 37: Front Panel Section This figure is a snapshot of a Microsoft Error Notification pop-up with the title Warning: JavaScript Window – and the text entry: Some required fields have not been filled. An incompatible or invalid selection has been made. Please refer to the monograph. Below this text entry to the left is the button “OK” Back TIP: The weight/measure/number section can be entered as free text by applicants to show multiple container amounts for their products. Any panel: The Any Panel section contains five subsections:
Applicant or Licence Holder A - Medicinal Ingredient; D - Recommended Conditions of Use; Recommended Dose; and Provided by Applicant. Certain fields within the Product Licence Holder subsection, as in Figure 38: Product License Holder Subsection below can be visible for label text purposes. Figure 38: Product License Holder Subsection Figures 38 is a snapshot of attestation statements that must be accepted for successful validation. The first one is located in PART 4 – PRODUCT INFORMATION under the segment 70. ‘Primary Brand Name*’ the following statement needs to be confirmed: “This product is for the general homeopathic medicine claim only. The brand name must not indicate or imply a specific claim, recommended use or purpose.” Below this statement to the right there is a box with the statement I agree* To the right of segment 90. Method of Preparation* is an additional statement that needs to be confirmed: “All medicinal ingredients of animal origin (nosodes, sarcodes, ect.) must be sterilized as per HPUS and HAB requirements or equivalent. Below this statement, to the right, there is a box with the statement “I agree*”. Back All fields within the A - Medicinal Ingredient subsection are fixed based on information entered in the ePLA. These fields cannot be revised. See figure 39.
Figure 39: A - Medicinal Ingredient Subsection Figures 39 is a snapshot of attestation statements that must be accepted for successful validation. In this figure there are two attestation statements highlighted. The first one is located in PART 4 – PRODUCT INFORMATION under segment 70. Primary Brand Name* The following statement needs to be confirmed: “Any claim indicated or implied in the brand name must be supported by evidence”. Below this statement, to the right, there is a box with the statement I agree*. Please note under segment ‘77. Homeopathic Potency*’ the following statement is included: “When the Homeopathic Potency is above 30CH or below the minimum OTC limit as described in the Homeopathic Pharmacopeoias, then additional scientific rationale must be submitted”. To the right of segment 90. Method of Preparation* the following statement needs to be confirmed: “All medicinal ingredients of animal origin (nosodes, sarcodes, ect.) must be sterilized as per HPUS and HAB requirements or equivalent. Below this statement, to the right, there is a box with the statement I agree* Back The fields within subsection D - Recommended Conditions of Use are populated from information in the ePLA and may be replaced with a statement to the effect; as in Figure 40: D - Recommended Conditions of Use Subsection, Figure 41: Recommended Dose Subsection, and Figure 42: Risk Information Subsection.
Figure 40: D - Recommended Conditions of Use Subsection Figures 40 is a snapshot of attestation statements that must be accepted for successful validation. In this figure there are two attestation statements highlighted. The first one is located in PART 4 – PRODUCT INFORMATION under segment 70. Primary Brand Name* The following statement needs to be confirmed: “Any claim indicated or implied in the brand name must be supported by evidence”. Below this statement, to the right, there is a box with the statement I agree*. Please note under segment 77. Homeopathic Potency* the following statement is included: “When the Homeopathic Potency is above 30CH or below the minimum OTC limit as described in the Homeopathic Pharmacopeoias, then additional scientific rationale must be submitted”. To the right of segment 90. Method of Preparation* the following statement needs to be confirmed: “All medicinal ingredients of animal origin (nosodes, sarcodes, ect.) must be sterilized as per HPUS and HAB requirements or equivalent. Below this statement, to the right, there is a box with the statement I agree* Back Figure 41: Recommended Dose Subsection Figure 41 is a snapshot of a search page for Homeopathic Ingredients. This figure has 2 segments. The first one displays the search box with the text “Keyword” to it’s left. Below the search box is a search button. Results are displayed in the second segment of the page with the text “Please click on an ingredient name to add the ingredient to the form”. Back Figure 42: Risk Information Subsection Figure 42 is a snapshot of fields that are unique to homeopathic applications. There are 3 segments highlighted in this figure: 77. Homeopathic Potency* which has scale:* with a selectable drop down menu. The next segment is 78. Synthetic * with two radio buttons: Yes and No. To the right is Animal Tissue used* with two radio buttons: Yes and No. Back Within the Provided by Applicant subsection, as in Figure 43: Provided by Applicant Subsection below, there exist optional additional fields that may be completed: Recommended Storage Conditions (for which the default value is "None"), and the display of the lot number.
Figure 43: Provided by Applicant Subsection Figure 43 is a snapshot of the Product Information Summary button located at the far right of the PART 4 – PRODUCT INFORMATION header. Back Outer label text only: The Outer Label Text Only section, such as in Figure 44: Outer Label Text Only Section below contains two subsections: B -Non-Medicinal Ingredient and Mercury Statement. The fields within the B -Non-Medicinal Ingredient subsection cannot be changed using the Label Text Editor; they can only be changed by modifying them in Part 4 of the ePLA form. If the product contains mercury, you must specify "Yes" in the Product Contains Mercury field of the Mercury Statement subsection. A mandatory field entitled Quantity of Mercury Statement will then appear and will need to be filled.
Figure 44: Outer Label Text Only Section Figure 44 is a snapshot of the Product Information Summary Report that summarizes the information entered in Part 4 – Product Information Back Security package: All fields within the Security Package subsection, illustrated in Figure 45: Security Package subsection below, 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.
Figure 45: Security Package Subsection This figure is a snapshot of the Medicinal Ingredient(s) portion of the form under part A. It contains 12 segments. From top to bottom and left to right. In first field 75.* the form asks for the proper name giving choices in a drop down menu, text entry in this field is : “Trigonella foenum-graecum L (Fabaceae). To the right of this segment, it has the entry Common Name* with also a drop down menu. In segment 73 a required entry is the Standard or Grade with a drop down menu. Right of this segment can be found the Ingredient Type*, with the text entry “Defined Organism Substance”. Right of this segment 77a. is defined as Quantity per dosage unit*. At the right of this segment there is 77b. Unit of Measure*. Below, to the left of this level is 79. Animal tissue** segment that provides, two radio buttons : “Yes” and “No”. At the right of this segment, the box asks if the ingredient is Synthetic* with two radio button that are a “Yes” and a “No”. At the right of this segment, the box asks if there is Additional Quantity and Additional Units. On the level below, Source material(s)* are required with the text entry: Trigonella foenum-graecum - Seed, with a drop down menu to the far right of segment. In this field there is the option to Add a source material by clicking the add a source material at the left of the box. Below this segment can be found the Methods of Preparation * with a selectable drop down menu. Text entry is “Powdered” Back Specialized labelling - inner and/or outer: The content of the Specialized labelling section depends on the application type. For applications of type Compendial, Traditional, Non-traditional and TPD Category IV, the Specialized Labelling -Inner and/or Outer 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 the three homeopathic application types, the Specialized Labelling -Inner and/or Outer 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 while in the Label Text Editor by selecting the "View Label Tex" t button. The label text can be printed at any time by selecting the" Print Label " button. Viewing the label text by selecting the "View Label Text" button makes it easier to identify any required changes. Should the changes be required in other parts of the ePLA (for example Part 4), it is best to group the changes together. When viewing the label text, the label text can be copied to another software application, such as Microsoft Word or Notepad by performing the following:
Select the "Copy Label" button; Position the cursor within the Copy Label text; Press the Control-A keys to select all text; Press the Control-C keys to copy the text to the Windows clipboard; and Paste the label text from the Windows clipboard into the software application for additional modifications and/or editing. Please note that copying 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 Label Text Editor and subsequently cannot be validated within the ePLA Form. This means that if you wish to use the modified label text for the Product Licence Application, you must therefore submit the modified text separately from the ePLA (see Section 3.6.3 - Label Text Submitted Separately below).
Once all of the desired label text changes have been entered along with the mandatory label text information, the text must be validated by selecting the " V alidate
" button. If some mandatory fields have not been specified, the fields in error will have a coloured background. Figure 46: Successful Label Text Validation Result This figure is a snapshot of the Recommended Dose, containing 10 segments. From top to bottom and left to right the first field is 107. Sub-population group* with a example text entry “Adults”. Directly below the next segment refers to dosage with the text Min.* and Max.*. To the right, there is segment 110. Dosage Units* with a dropdown menu with the choices: Cream, Millimetre(s) & Container(s). The next segment to the right is Frequency with the text entry Min* and Max* (times a) to the right Frequency Units*/ day with a drop down menu. The next segment located to the right is Additional Dosage Information (ex. 1 scoop = 30g). The next segment below from left to right is 112. Direction of Use with the text : “Add to hot bath” as a example. To the right is Additional Directions of Use. Below is 106. Duration Statement. Back When the label text is validated successfully, a message will be displayed as shown above Figure 46: Successful Label Text Validation Result. The Label Text Editor can now be closed by selecting the "Close" button. The Label Text Editor can in fact be closed at any time by selecting the "Close" button. The result of a successful label text validation is shown below in Figure 47: Successful Label Text Validation in ePLA.
Figure 47: Successful Label Text Validation in ePLA This figure is a snapshot of the NHP Online Label Text Editor, it is composed of multiple parts with sub-sections, the ones that are shown in Figure 47 are: Principal Display Panel, Any Panel, Outer Label Text Only and Security Package. Each of those categories has a Hide button that can be selected to the far right of the heading. Back Once all issues with Label Text have been resolved, the Label Text has been validated successfully and the Label Text Editor has been closed, click the "Continue" button on the ePLA. This step indicates that Part 5 of the form is complete.
If you intend to submit the label text separately rather than generate it as part of the ePLA
, click the " Label Text Submitted Separately
" checkbox within Part 5 - Label Text of the ePLA
Form, as illustrated in Figure 48: Label Text Submitted Separately Checkbox
Figure 48: Label Text Submitted Separately Checkbox This figure is a snapshot of the ANY PANEL subsection with a checkbox to hide the category at the far right of the heading. Below is an additional heading with the title: Applicant or License Holder with a checkbox to hide the category at the far right of the heading. This sub-section has 7 segments. The first from top to bottom and left to right is Company Name. Below is located Street/Suites/Land Location with a checkbox on the far right to include text on label. Next segment is City with a checkbox to the right to include on the label. To the right of this segment is Province with a checkbox to the right to include on the label. Below to the far left is Country. To the right of the segment the field asks for a Postal Code. The last segment is titled Additional License Holder Information. Back 3.7 Animal tissue form
For medicinal ingredients, in Part 4 - Section A For processing of ingredient question (for homeopathic ingredients only), in Part 4 - Section A For non-medicinal ingredients, in Part 4 - Section B For ingredients used in processing question, in Part 4 - Section C The following message in Figure 49: Animal Tissue Form Added Message is shown when the ATF is added:
Figure 49: Animal Tissue Form Added Message This figure is a snapshot of the A- Medicinal section with a checkbox to hide the category at the far right of the heading. This Figure contains 6 segments. Below is listed Ingredient with the text “1” and a check box to the far right to hide this field. Below is Proper Name with the text “Borago officinalis (Boraginaceae). Below this segment is Source with the text “Borago officinalis – Seed”. Below this segment is Quantity per Dosage Unit with the text “1 Grams” The last segment of this snapsahot at the bottom Additional Quantity and Units. Back For medicinal ingredients and for non-medicinal ingredients, the ATF is pre-filled with the ingredient name and the "Ingredient" value is selected.
Note that the pre-filled values cannot be changed as they represent the information entered in Part 4 of the ePLA. If additional information regarding Animal Tissue must be provided, use the "Add another Animal Tissue Form" button to generate more forms as needed so all information is captured. "The "Return to Part 4" button allows you to return to the end of Part 4 after having completed the Animal Tissue Forms.
Once all parts of the ePLA have been validated, one or two Attestation boxes will appear. For applications of type 'Compendial' only, there will be two attestations. The attestation shown in Figure 50 below is common to all application types. Selecting the "I Agree" checkbox signifies that the senior official of the company applying for the licence (defined in Part 1, Block 'B') attests to the provided statements. Upon selection, the block displays an Attestation Code Figure 50: Attestation block common to all application types This figure is a snapshot of the D-Recommended Conditions of Use section with a checkbox to hide the category at the far right of the heading. This section has 5 segments. The first one is Recommended Use or Purpose on ePLA with the text : “Source of essential fatty acids for the maintenance of good health” and “Source of linoleic acid (LA) for the maintenance of good health. Below is the sub-section titled Duration of use, with below the segment Duration of Use on ePLA. The last segment of this snapshot is Replce with statement to the effect of. Back For applications of type Compendial, a second attestation, as shown in Figure 51 below, will be present. Once again, selecting the "I Agree" checkbox signifies that the senior official of the company applying for the licence attests to the provided statements. Upon selection, the block displays an Attestation Code.
Figure 51: Attestation block for Compendial applications This figure is a snapshot of the Recommended Dose Subsection with a checkbox to hide the category at the far right of the heading. This subsection has 7 segments. The first from top to bottom and from right to left is Sub-population with the text “Adults”. Below in the next segment is Phase. Below this is Recommended Doses with the text “2 Capsule(s) 2 time(s) per day. Below the next segment is Additional Dosage Information with a checkbox to hide the category at the far right of the segment. Below the next segment is Directions of Use on ePLA. Below the the next segment is Replace with statement to the effect of. The last segment is Additional Directions of Use with a checkbox to hide the category at the far right of the segment. Back The "Finalize" button will appear at the end of the form after all the subforms (i.e. after any ATFs).
Once all finalization issues are resolved, the form finalization displays at the top and bottom of the form, see Figure 52: Successful Form Finalization Message below.
Figure 52: Successful Form Finalization Message This figure is a snapshot of the Risk Information Subsection, it displays 6 segments. The first from top to bottom and from right to left is Cautions and Warnings on ePLA. Next one below is Replace with statements to the effect of. The next segment below is Contraindications information on ePLA. The next segment below is Replace with statement to the effect of. The next segment below is Adverse Reactions Information on ePLA. The last segment of this subsection is Replace with statement to the effect of. Back The finalized form also is assigned a unique tracking number displayed at the top of each page. This tracking number will remain the same regardless of the number of times the finalized form is modified.
TIP: Prior to finalizing your form, the NHPD recommends that you save a copy of your ePLA to avoid potential issues with the ePLA's tracking number in the future. We recommend the following steps: The applicant will enter all information pertaining to their product into the ePLA. The applicant will be asked to finalize their ePLA. At this point they must save the ePLA prior to finalizing using a unique name. (e.g. Garlic123456Unfinalized.pdf) The applicant will finalize the ePLA and save it again with a different name (e.g. Garlic123456Finalized.pdf) The applicant will submit the finalized version, but keep both ePLAs on file. Any time the applicant needs to submit a new application to the NHPD, they are free to modify the unfinalized version of their ePLA and follow the same steps listed above. Step 3 - Assemble and submit After finalization, as indicated in the finalization message, the completed form is ready to be saved on your workstation and then submitted as per the Product Licence guidance document. Should you choose to print the electronic form and send it to NHPD via regular mail, please note that the electronic form will only print properly once certain conditions are met. In order to print properly, the electronic form must be finalized, saved, and closed first. When the form is ready to be printed, the closed finalized form can be reopened and then printed.
3.8.1 Product information summary
The Summary of Product Information displays the contents of Part 4 by showing each ingredient, whether medicinal or non-medicinal, in a single line. The summary can be viewed after completing an application by clicking the "Summary" button of the bottom finalization message.
This will generate an onscreen report of one or more pages that can be printed as desired, as shown in Figure 53: Product Information Summary report below.
Figure 53: Product information summary report This figure is a snapshot of the Provided by Applicant Subsection, it displays 2 segments. In the header Provided by Applicant, a button titled Add a Storage Condition appears to the far right side of the title. Additionally there is a check box to the right to hide this subsection. Below the next segment is Recommended Storage Conditions with the text “None”. Below the last segment is Select a Lot label with a drop down menu to the right. Back To return to the ePLA, select the "Close" button.
The "Modify" button can be used to update an already-submitted application in response to a notice from the NHPD or if modifications are required during the application process. The NHPD uses the tracking number on the form to locate and replace the previous version.
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), Parts 1 through 4 need to be re-validated by selecting the "Continue"button at the end of Part 4. In Part 5, 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.
Select the "Post-Licence Change" button from the form finalization message (see Figure 51: Successful Form Finalization Message). This makes a copy of Parts 1 to 4 of the original ePLA and clears the tracking number. A new section appears in Part 2 as shown in Figure 54 - D. Post-Licence Change. This section indicates that this ePLA is for a previously-licensed product and has a location to capture the NPN for that product. The eight digit NPN must be provided. You can then complete the form with the post-licence changes (including Part 5 - Label Text), successfully finalize it (to get a new Tracking Number) and send it in.
Figure 54: D. Post-Licence Change This figure is a snapshot of the Outer Label Text Only Section, it displays 4 segments. In the header Outer Label Text Only a checkbox to hide the category is located at the far right of the heading. Under the title B – Non medicinal Ingredient is the segment Non-medicinal Ingredient (Reference Only): 1. Below to the left is the segment Common Name with the text “Gelatin”. To the right is the segment Unit with the text “Gelatin digesting units”. To the right on the same level is Quantity with the text “2” a checkbox to include on the label is located at the far right of the heading. The last segment is Product contains Mercury with a drop down menu with the choices “Yes” and “No” Back 4.3 New application activity
4.4 Importing an application
In order to use the latest version of the ePLA with information already entered in an older version of the electronic form, one can use the Import/Export feature of Adobe forms. Currently, this will only work to move information found in an ePLA of version 2.0.1 or greater into an ePLA of version 2.1 or greater. The import feature does not work for ePLAs of version 1.4.4 or older into version 2.1.
To export information from an ePLA of version 2.0.1 (or greater) into a version 2.1 (or greater) of the electronic form, here are the steps to follow:
Open the ePLA of version 2.0.1 (or greater). From the 'Forms' menu at the top, select 'Manage Form Data', and then 'Export Data'. Save the xml export file at a convenient location. Open a new ePLA of version 2.1 (or greater). From the 'Forms' menu at the top, select 'Manage Form Data' and then 'Import Data'. Select the previously exported xml file. The information transfer will take a few seconds. The content of the new ePLA should be checked to confirm that all data was properly moved. A transferred finalised form may have to be refinalised. Report a problem or mistake on this page