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Helping the people Aider les Canadiens et

of Canada maintain and les Canadiennes à améliorer


improve their health leur état de santé

Health Canada Workshop


March 2011
Natural Health Products Directorate
Health Canada
Opening Remarks and Overview of the Day

Welcome
Overview
1. Completing your ePLA
2. Completing your application
3. Submitting your application
4. Helpful info and links

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Collecting Information
• Use the NHPD website to collect information before submission
www.healthcanada.gc.ca/nhp

• Guidance documents:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/index-
eng.php

• What’s new section:


http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php

• BPRA_BEEP email messages

• Natural Health Product Ingredient Database


http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do

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Completing your ePLA
Completing your ePLA

• www.healthcanada.gc.ca/nhponline
• NHPID
• PCI
• NMI
• Standard Terminology
• Issue Form
• Compendial from Generated Monograph
• Non-Compendial
• Label text

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Natural Health Product Ingredient Database

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Searching Tips

• magnesium/*magnesium* = searches for all occurrences of


magnesium in any ingredient occurrence

• magnesium* = searches for all ingredients that start with


magnesium

• *magnesium searches for all ingredients that end with magnesium

• mag*sium = searches for all ingredients that start with Mag & end
in sium

• “magnesium” = searches for exact match

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Searching Tips – cont.

• Queries are not case sensitive


• e.g. Magnesium, magnesium and MAGNESIUM return the
same results
• Accents are recognized
• e.g. important for searches in French where magnesium returns
nothing while magnésium gives you what you want.
TIP: Use an asterix in place of accent, e.g. magn*sium
• Alternate Spelling
• E.g. flavor vs. flavour

• For more information see the NHPID User Guide:


http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-
enligne/nhpid-bipsn-eng.php

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Feedback on the NHPID

• If you wish to add new data to the NHPID (ingredient,


source, purpose etc) or modify existing data, a NHPID
Issue Form should be completed and sent by email to
ingredient_support@hc-sc.gc.ca
• Any other feedback on the NHPID can also be sent by
email to the ingredient support account

Issue form available at:


http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-
enligne/issue_form_view-eng.php

Issue form user guide:


http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/issue_form_demande-eng.php

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Issue Form

DEMO

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ePLA

• Electronic “smart” form


• Linked to the Ingredient database
• Single ingredient generated monographs
• Self validation for completion
• Label text generator built in

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ePLA benefits

• Once validated all minimum PLA form requirements


are met
• No refusals for incomplete forms
• Link to NHPID ensures consistent and validated
naming conventions
• Can be submitted electronically through PosteCS
• Moves to review stages faster – minimizes processing
checks internally at NHPD

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ePLA- tips

• Meet system requirements


• Use only the latest version of ePLA
• Configure proper security settings
• Save work frequently
• Establish a checkpoint before beginning a significant task
• Become familiar with monographs beforehand
• Change an ingredient wisely

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ePLA Overview

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ePLA - CfGM

• CfGM application type – search based on monograph


• Only single Ingredient monographs at this time
• Monographs marked with an * in the NHPID are
available to be generated in an ePLA
• Information is pre-populated in the ePLA and CfGM
will validate dose, claims, directions of use and risk
information

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ePLA - CfGM

DEMO

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ePLA – Non-compendial

DEMO

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Label Text Editor - LTE

• regulatory label text Generated from the ePLA


• Ensures proposed label text matches the PLA
• Select fields can be modified (e.g. statements to the
effect of)
• To meet the application requirements the applicant
can:
• submit generated label text ‘as is’ or modified; or
• submit own proposed label

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Managing ePLA documents

• Versioning of ePLA
• ePLA export feature
• Imports data from older version to the newest version
• 1.4.1 and later

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Completing your
application
Completing your Application

• In order to issue a product licence, the NHP


Regulations require information that supports the
safety, efficacy and quality of the natural health
product
• Two ways to meet this requirement:
1. Compile evidence and submit it to NHPD
2. Refer to information or decisions that have been
pre-cleared by NHPD
• Using pre-cleared information (PCI) allows NHPD to
focus its review on novel information that has not been
pre-cleared, therefore speeds up the application
review*

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Meeting Application Requirements

• Completed product licence application (PLA) form


• Proposed label text
• Safety evidence for each ingredient and/or product
• Efficacy evidence for product
• Any additional information required to mitigate risk or
supplement the evidence package
• E.g. combination rationale, reference to a master file,
other rationales, Evidence Assessment Template etc.
• Finished Product Specifications (FPS)
• Authorized signature (Designated Party Authorization
(DPA) form if required)

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PLA Requirements: Non-trad Checklist

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Types of PCI - Quality

• NHPD Recognized Test methods are available under


the Controlled Vocabulary search in the NHPID.
• Search under category ‘Test Methods’
• Equivalent validated in house methods are also
acceptable
• List of Recognized Test methods not exhaustive;
methods can be added to the NHPID using the NHP
Ingredient Database Issue form
• Requests must include details such as test type,
protocols, validation information, etc.
• Tolerance limits outlined in tables found in Finished
Product Specification User Guide

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Finished Product Specification Form

• FPS ensures all quality requirements are provided to NHPD


• Attestation format that allows applicant to use PCI  Recognized
Test Methods and Tolerance Limits
• Improves/speeds up quality assessment process
• Fewer IRNs and fewer points on IRN
• Eventually form will be required for all new PLAs
• FPS User Guide accompanies form
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/guide-manuel_fps-
spf-eng.php

FPS:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-
prod/form/form_fps-spf-eng.php

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FPS

DEMO

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Types of PCI – Safety & Efficacy

• 173 Single Ingredient Monographs


→ 154 of these are Generated for use in the ePLA
• 18 Product Monographs
• 14 Abbreviated Labelling Stds (AbLS)
• 6 NHPD Labelling Stds
• 18 TPD Cat IV Monographs/Labelling Stds

Available through the NHPID:


http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do

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Tools for meeting Evidence Criteria - Templates

• The Evidence Assessment Template


• helps to organize evidence
• ensures that the evidence is complete, of high quality
and sufficient to warrant an in depth review.
• is to be used with Evidence Criteria document

Both documents published on NHPD website November


2009
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-
avis_evid-preuv_temp-model-eng.php

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Evidence Assessment Template - Example

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eSubmission Builder - eSB

• Desktop Program
• Easy installation and use
• Functions with finalized ePLAs
• Self validating for completion
• Ensures all application requirements are satisfied
• Specific to each application type
• Referencing tagging
• Intuitively identify reference documents
• Unique file type
• Saves file as .hcs

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eSB

DEMO

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Submitting your
application
Submitting ePLA electronically

• Trading partner
http://www.hc-sc.gc.ca/dhp-
mps/prodnatur/applications/online-enligne/enrol-inscrire-
eng.php
• PosteCS
http://www.canadapost.ca/business/offerings/postecs/index.ht
ml

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Benefits of TP and PosteCS

• Cost effective: 100 Mb capacity for multiple


submissions at once
• Easy to use
• Receipt confirmations and tracking
• All correspondence documents (IRNs, Product
Licence etc.) sent in electronic .pdf format
• Efficient

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Trading Partner

• establishes the PosteCS address of each


individual as the electronic equivalent of a
personal signature.

• Confirm your identity


• Establish your signing authority

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Trading Partner Profile

3 enrollment options for submitting ePLA applications:


• Applicant company
• Only company employees can submit applications
• Third party Consultant
• Consultants can submit on behalf of the company
• Consultant must have DPA from applicant company
• Both Applicant Company and Third party consultant
• Both can submit and receive information electronically
• Trading partners must meet established requirements
• To enroll: email NHP_Initiative_PSN@hc-sc.gc.ca

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Trading Partner Profile

3 Components
• Trading Partner Agreement ;
• Trading Partner Profile Form; and
• Signing Authority template.

Guidance Document
http://hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-
enligne/enrol-inscrire-eng.php

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Trading partner Overview

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Secure email

• Secure email service:


• Based on service from Canada Post;
• Sign-up and account administration handled
directly by each applicant;
• Sender pays (just like regular mail and courier);
• Cost varies from $3.00 to $0.60 per package
depending on volume;
• PosteCS - mail service legally protected by the
Canada Post Corporation Act and the Criminal Code
of Canada
• www.postecs.ca

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Secure e-mail – cont.

• https://cpc.postecs.com/

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NHPD Online Solution Overview
Applicant fills ePLA

ePLA links to NHPID


•PCI
Applicant finalizes
ePLA NHPD receives

PosteCS
application

Applicant invokes NHPD processes and


eSubmission Builder assesses application
•Applicant adds
supporting evidence
NHPD communicates
Applicant submits with applicant
application

Applicant responds as
necessary NHPD issues decision

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Helpful Info and Links
Licenced NHP Database

• The Licensed Natural Health Products Database


(LNHPD) contains product specific information on
those natural health products that have been issued a
product licence by Health Canada.
• Can identify licensed natural health products by
looking for the eight-digit NPN or DIN-HM
designation on the label.
• Updated daily
• Also available as a searchable extract (for external
database)

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LNHPD live on NHPD website

http://webprod.hc-sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?lang=eng

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Tools for Meeting Requirements

• Labelling Requirements Checklist


http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/label-list-
etiquet-eng.php

• Compendial PLA Completeness Checklist


http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-
prod/form/comp_list_officinale-eng.php

• Evidence assessment Template


http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-
avis_evid-preuv_temp-model-eng.php

• NHPID
• ePLA
• eSB

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Take Home Message – To Do List!

Plan applications in advance


Check NHPID for ingredients and PCI
Send in NHPID Issue form
Use ePLA
Use eSB
Sign up to be a Trading partner & have PosteCS email
to submit electronically

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Contacts

• PLA info email: PLA.info.DLMM@hc-sc.gc.ca


• Ingredient support: ingredient_support@hc-sc.gc.ca
• NHP Initiative: NHP_initiative_PSN@hc-sc.gc.ca

• Shawn Lawless: shawn.lawless@hc-sc.gc.ca


• Amy McDonald: amy.mcdonald@hc-sc.gc.ca
• Lisa Young: lisa.m.young@hc-sc.gc.ca
• Sara O’Connor: sara.oconnor@hc-sc.gc.ca

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Resources

• Natural Health Products Directorate Website


• www.healthcanada.gc.ca/nhp
• Marketed Health Products Directorate Website
• http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-
dpsc/index-eng.php
• Health Products & Food Branch Inspectorate Website
• http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php
• Licensed Natural Health Products Database
• www.healthcanada.gc.ca/lnhpd
• Online Solution
• www.healthcanada.gc.ca/nhponline

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Resources
• Guidance documents
• http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/index-eng.php
• Acts and Regulations
• http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-
lois/prodnatur/index-eng.php
• Online Forms and Templates
• http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-
enligne/guidance-reference-eng.php
• What’s new section
• http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php
• Consumer Advertising Guidelines for Marketed Health Products
• http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-
ldir_consom_consum-eng.php
• Guidelines for Cosmetic Advertising and Labelling Claims
• http://www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmet/index-eng.php

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Further Information

Web site: www.healthcanada.gc.ca/nhp - from


this main page you can access most popular
sections including What’s New, Quarterly
Reports, LNHPD and Online Solution

For general inquiries, please contact us at:


PLA.info.DLMM@hc-sc.gc.ca

For detailed application questions contact your


Submission Coordinator

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