Helping the people of Canada maintain and improve their health

Aider les Canadiens et les Canadiennes à maintenir et à améliorer leur état de santé

Path Forward on Natural Health Products

Natural Health Products Directorate

CHFA Quebec February 1, 2013

Overview of Current Status

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• For more than a year, NHPD has been consulting on and implementing a new approach to NHPs

• Focus has been on streamlining product review and licensing

• Now there is a predictable, stable regulatory environment to ensure continued efficient licensing

• As planned, the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR), ends this month

Current Status

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• Introduction of a 3-class system of product review based on level of certainty, keeping the focus on complex, higher risk products Class I (highest certainty) accounts for 75% of products; many being licensed within

30 days Goal is to reduce class I review time even further with ongoing addition of enabling

tools and processes

• Publication of the Pathway for Licensing NHPs guidance includes new tools and pathways to market (e.g. general health claims)

• Refocused quality review and guidance Updated guidance (being finalized) provides (1) flexibility to account for advances in

technology & expertise, (2) multiple pathways for ensuring high quality NHPs

• Cross-country stakeholder consultations in November 2012 Provided opportunity to discuss elements of new approach and hear stakeholder

views

Progress Under the New Approach to NHPs

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How much will review times be reduced?

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Results: Before and After the Changes

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Product Licensing – Backlog Elimination

• New Exemption Numbers (ENs) will no longer be issued

• Exempted Products Database will remain operational during transition phase

but no new products will be added as of the end date of NHP-UPLAR

• There is a compliance and enforcement transition plan in place to address products still labelled with ENs and advertising of these products

NHP-UPLAR Repeal

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• Moving beyond NHP-UPLAR Refer to the published Q&As

• Reset targets for product licensing based on 3-class system and focus on continuous improvement

• Continue roll-out of the new approach Final Pathway for Licensing guidance published in December 2012 Finalization of the Quality Guidance Document

Moving forward

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• Transparency initiatives continue

• Consultations on: new site licensing pilot new pre-cleared information updated guidance on management of product license

applications updated Compendium of Monographs

• Publication of January –June 2013 calendar of NHPD anticipated activities

Moving forward

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Compliance and Enforcement

Transition

- Overview

- Stakeholder Engagement

- Transition Timeline

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• New Approach to NHPs sets the foundation for moving forward

Finalization of the Pathway for Licensing guidance provides clarity on requirements and offers new pathways to market

With the repeal of NHP-UPLAR, no new ENs to be issued

Streamlining of application review means timely licensing decisions and no need for ENs

These improvements have brought clarity to the marketplace

Introducing a Transition Period—Why Now?

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• There will be an 18 month transition period• The transition period will enable companies to make adjustments to

business practices and phase-out products that are not in compliance • Health Canada solicited feedback on the proposed timeline including

during the workshops held in November 2012. • The end of NHP-UPLAR does not signal an immediate change in

compliance and enforcement for NHPs.

Risk Based Approach

Our objective is to manage risk and use the most appropriate level of intervention so the regulated party comes into compliance. Products found to pose a risk to health may be subject to compliance and enforcement actions.

Overview of the Transition Period

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• Health Canada consulted on a transition period to: Ensure transparency and openness Take into account the potential range of existing business

practices Ensure a successful transition towards compliance

Over 700 stakeholders attended workshop sessions, feedback was solicited via a participant workbook. 280 workbooks were received.

• Overall Timeline (18 Months): 72% of respondents agreed

Engagement on the Transition Period

9 MONTHS 9 MONTHS

November 2012Roadshow: Seek feedback on proposed timeline

Feb 2013Repeal NHP - UPLAR

December 1, 2013Manufacturer/Packagers/Labelers should only distribute NHPs that have market authorization

All imported NHPs should have market authorization

Phasing out of non-market authorized products continues

September 1, 2014Distributors/Retailers should no longer sell NHPs that do not have market authorization

NHP C&E Policy come into full effect

March 1, 2013 Preparation: Companies review products status and supply

Phasing out of non-market authorized products begins

Dec - Jan, 2013 Review feedback and announce timeline

Proposed Timeline

TIMELINE FOR PROPOSED NHP C&E

ONGOING RISK BASED APPROACH

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First Phase: Mar 1, 2013 – Dec 1, 2013

• Goal 1: To enhance awareness of the Natural Health Products Regulations (NHPR), so that companies have what they need to understand and comply with the Regulations

• Goal 2: Allow companies time to plan for phasing out the distribution of non-market authorized product

• Health Canada is distributing educational tools such as Fact Sheets and FAQs for Industry, Retailers, and Practitioners

• Further support will include items such as Outreach (webinars), Bulletins, Reminders, Bi-Lateral Programs & Trade Shows

Risk Based Approach

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• Goal: All imported or manufactured NHPs should have market authorization; only NHPs with market authorization should be imported/distributed

• The phasing out of non-market authorized product continues at the retail level

• NHPD and Inspectorate staff available to answer questions

Risk Based Approach

Second Phase: Dec 1, 2013 – Sept 1, 2014

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Implementation: September 1, 2014 - onwards

• Goal: The transition period (phase out) is complete and all products should have authorization before coming onto the market (NPN or DIN-HM)

Risk Based Approach

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• Safety of Canadians is Health Canada’s highest priority

• Health Canada focuses its efforts on products that demonstrate a potential risk to health

• Health Canada will continue to be committed to verifying issues or complaints regarding the quality or safety of health products

• Objective is to mitigate the risk using the appropriate level of intervention

• Compliance is normally achieved through a cooperative approach between the regulated party and Health Canada

Summary of Compliance Approach

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Your suggestions

The Inspectorate would like to hear your suggestions on how we can help raise awareness of the Transition Period:

Insp_NHP_PSN@hc-sc.gc.ca