Professional Documents
Culture Documents
Welcome
Overview
1. Completing your ePLA
2. Completing your application
3. Submitting your application
4. Helpful info and links
2
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
3
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
• mag*sium = searches for all ingredients that start with Mag & end
in sium
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Searching Tips – cont.
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Feedback on the NHPID
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Issue Form
DEMO
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ePLA
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ePLA benefits
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ePLA- tips
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ePLA Overview
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ePLA - CfGM
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ePLA - CfGM
DEMO
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ePLA – Non-compendial
DEMO
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Label Text Editor - LTE
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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
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Meeting Application Requirements
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PLA Requirements: Non-trad Checklist
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Types of PCI - Quality
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Finished Product Specification Form
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
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Tools for meeting Evidence Criteria - Templates
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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
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Trading Partner
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Trading Partner Profile
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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
37
Trading partner Overview
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Secure email
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Secure e-mail – cont.
• https://cpc.postecs.com/
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NHPD Online Solution Overview
Applicant fills ePLA
PosteCS
application
Applicant responds as
necessary NHPD issues decision
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Helpful Info and Links
Licenced NHP 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
• NHPID
• ePLA
• eSB
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Take Home Message – To Do List!
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Contacts
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Resources
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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
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