Management of Product Licence

Applications for Natural Health Products

-Attestations-
Natural and Non-prescription Health Products Directorate
(NNHPD)
Winter 2017
Table of Contents

Slides 3 - 5: Before Submitting a Product Licence Application (PLA)

Slides 6 - 12: Attestation to NNHPD Monographs
Slides 13 - 15: When Are Monograph Conditions Not Required?
Slides 16 - 17: Post Licensing Audit
Slide 18: References

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Before Submitting a Product Licence
Application (PLA)

3
 Before Submitting a PLA

•All medicinal and non-medicinal ingredients must be present and

compliant with the Natural Health Products Ingredients Database
•Applicants are encouraged to:
• Use the latest Electronic Product Licence Application (ePLA)
• Use the NHP Online eSubmission Builder (eSB) to create
electronic submission packages
• Enrol as a Trading Partner to use NNHPD’s chosen secure
communication service: epost ConnectTM
• New applications must be sent to the “new applications”
conversation
•All applications must have a unique ePLA tracking number

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 Before Submitting a PLA

• Applicants must notify the NNHPD prior to submitting a large

volume of applications at one time in order for the NNHPD to
work with the applicant to develop a plan for processing and
assessing applications within the service standards

• For all PLAs and amendments, the cover letter must indicate whether
the application is Class I, II or III; applicants will be notified for any
applications they identified as Class II that are shifted to Class III

5
Attestation to NNHPD Monographs

6
 Attestation to NNHPD Monographs

• All Class I, II and III PLAs and amendments containing one or

more ingredient(s) supported by NNHPD monograph(s) for safety,
efficacy and/or quality are required to submit a Monograph
Attestation

• The Monograph Attestation is embedded in the ePLA for certain

application types or as a standalone form online

• The attestation is confirmation from the applicant that their product

complies with the identified monograph parameters

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 Attestation to NNHPD Monographs

• Overview of attestation conditions, whereby applicants attest:

a) That the monograph parameters [proper name, common name,

source material, route of administration, dosage form, use or
purpose, dose, duration of use, risk information, etc.] are met;
b) That the non-medicinal ingredients fully comply with the Natural
Health Product Ingredients Database (NHPID);
c) That the label text is acceptable as per sections 86-94 of the
Natural Health Products Regulations;
d) That the brand name is not false or misleading; and
e) The selling of the product is within the conditions of the attestation
and terms of market authorisation (product licence).

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 Attestation to NNHPD Monographs

• For products fully supported by one or more NNHPD monographs:

• Check the first box on the attestation form (seen below)
• Do not complete the table on page two

• For products supported by a combination of both monographs and evidence

provided in the application package:
• Check the second box on the attestation form (seen below)
• Complete the table on page two to indicate which medicinal ingredients
meet an NNHPD monograph in support of safety, efficacy and/or quality
• Ensure evidence is provided for all non-attested components

Sample of the Monograph Attestation Form for products supported by a combination of

both monographs and evidence. See Slide 18 for form website address.

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 Attestation to NNHPD Monographs

• To attest to safety: all monograph parameters except minimum daily

dose and recommended use/purpose (i.e. claim) must be met
• To attest to efficacy: monograph parameters of source, minimum daily
dose and recommended use/purpose (i.e. claim) must be met; claim
must be written in full on standalone attestation form
• To attest to quality: monograph specifications and Quality for NHPs
Guide must be met

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 Attestation to NNHPD Monographs

The following table demonstrates the applicable attestation (safety,

efficacy and/or quality) for several different scenarios:

Scenario for a Given Medicinal Ingredient Applicable Attestation

Safety Efficacy Quality
All monograph parameters are met X X X
All monograph parameters with the exception of minimum daily dose and X X
recommended use/purpose (claim) are met
All monograph parameters with the exception of minimum daily dose, claim X
and specifications are met
All monograph parameters with the exception of specifications are met X X
All monograph parameters with the exception of maximum daily dose are met X X
All monograph parameters with the exception of risk information and/or X X
duration of use are met

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 Attestation to NNHPD Monographs

If not attesting to a full monograph, clearly indicate the reasoning in

cover letter and ensure evidence or rationale has been provided

•E.g. if omitting required conditions of use, do not attest to safety;

instead indicate the reason for not attesting in the cover letter and
provide evidence or rationale to support the omission as part of the
application package
•E.g. if attesting to safety but not efficacy because the claim is not
supported by the monograph, ensure evidence is provided to support
the efficacy of the non-monographed claim

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When Are Monograph Conditions Not
Required?

13
 When are Monograph Conditions Not Required

In the following cases, monograph conditions of use are not required for an
ingredient to be supported by an NNHPD monograph:

•Sub-population-specific risk information is not required if the product is not

indicated for that sub-population
 E.g. the risk statement “if pregnant or breastfeeding, consult a health
care practitioner” is not required for a product indicated for an “adult
male” sub-population
•Risk information is not required from one monograph if it is considered less
stringent and overlaps the risk information of another ingredient in the product
 E.g. “if pregnant or breastfeeding, consult a health care practitioner
prior to use” is not required if the product contains the risk statement
“if pregnant or breastfeeding, do not use”

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 When are Monograph Conditions Not Required

• A duration of use relating to efficacy is not required if it is shorter than

the duration of use relating to efficacy required by another ingredient in
the product (i.e. use the longest duration when related to efficacy)
 E.g. “use for a minimum of 3 months to see beneficial effects” is
not required if the product’s duration of use will be “use for a
minimum of 6 months to see beneficial effects”

• A duration of use relating to safety is not required if it is longer than the

duration of use relating to safety required by another ingredient in the
product (i.e. use the shortest duration when related to safety)
 E.g. “consult a health care practitioner for use beyond 1 month”
is not required if the product’s duration of use will be “consult a
health care practitioner for use beyond 1 week”

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Post-licensing Audit

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 Post-licensing Audit

• The NNHPD conducts post-licensing audits (both random and

risk-based) of monograph-based applications (Class I, II and III)
to ensure there are no errors in the attestation (e.g. deviations
from the monograph)
• Objective: to ensure that the parameters against which applicants
have attested are met
• Applicants are notified of issues identified during the post-
licensing audit via a Notice of Audit Failure; should issues not be
addressed immediately within the specified time limit, compliance
action may be taken

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References
• Management of product licence applications for natural health products: http://
www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/pla-dlmm_manage-gestion-e
ng.php
• Approach to NHPs: http://
www.hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.php
• Natural Health Products Ingredients Database: http://
webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do?lang=eng
• Electronic product licence application form (ePLA): http://
www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/pla-dlmm-view-
eng.php
• Monograph Attestation form:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/form/
attestation-eng.php
• NHP Online eSubmission builder (eSB):
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/esb-gde-
intro-eng.php
• Guidance document on how to interact with the Natural Health Products
Directorate electronically:
http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/trading_part_commerce-eng.php 18