Management of Product Licence Applications for Natural Health Products

-Attestations-

Natural and Non-prescription Health Products Directorate (NNHPD)

Winter 2017

Table of Contents

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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

Before Submitting a Product Licence Application (PLA)

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• 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

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

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Before Submitting a PLA

Attestation to NNHPD Monographs

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• 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

Attestation to NNHPD Monographs

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• 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).

Attestation to NNHPD Monographs

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• 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

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Sample of the Monograph Attestation Form for products supported by a combination of both monographs and evidence. See Slide 18 for form website address.

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:

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Scenario for a Given Medicinal Ingredient Applicable AttestationSafety Efficacy Quality

All monograph parameters are met X X XAll monograph parameters with the exception of minimum daily dose and recommended use/purpose (claim) are met

X X

All monograph parameters with the exception of minimum daily dose, claim and specifications are met

X

All monograph parameters with the exception of specifications are met X XAll monograph parameters with the exception of maximum daily dose are met X XAll monograph parameters with the exception of risk information and/or duration of use are met

X X

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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Attestation to NNHPD Monographs

When Are Monograph Conditions Not Required?

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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 1month” 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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When are Monograph Conditions Not Required

Post-licensing Audit

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• 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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Post-licensing Audit

• Management of product licence applications for natural health products: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/pla-dlmm_manage-gestion-eng.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

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References