Helping the people of Canada maintain and improve their health

Aider les Canadiens et les Canadiennes à améliorerleur état de santé

Health Canada Workshop March 2011

Natural Health Products Directorate Health Canada

22

Opening Remarks and Overview of the Day

2

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

3

Completing your ePLA

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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

Completing your application

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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 formhttp://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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• 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

Types of PCI – Safety & Efficacy

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Tools for meeting Evidence Criteria - Templates

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• 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

Submitting your application

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Submitting ePLA electronically

• Trading partnerhttp://www.hc-sc.gc.ca/dhp-

mps/prodnatur/applications/online-enligne/enrol-inscrire- eng.php

• PosteCShttp://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

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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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Po

steC

SP

oste

CS

Po

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Applicant fills ePLA

Applicant finalizes ePLA

Applicant invokes eSubmission

Builder•Applicant adds supporting evidence

Applicant submits application

NHPD receives application

NHPD processes and assesses application

NHPD communicates with applicant

Applicant responds as necessary NHPD issues decision

NHPD Online Solution Overview

ePLA

links to NHPID•PCI

Helpful Info and Links

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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 Checklisthttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/label-list-

etiquet-eng.php

• Compendial PLA Completeness Checklisthttp://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