1. 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

2. Overview of Current Status 2

3. 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 3

4. 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 4

5. How much will review times be reduced? 5

6. Results: Before and After the Changes 6 Product Licensing – Backlog Elimination

7. 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 7

8. 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 8

9. 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 9

10. Compliance and Enforcement Transition - Overview - Stakeholder Engagement - Transition Timeline 10

11. 11 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?

12. 12 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

13. 13 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

14. 9 MONTHS November 2012 Roadshow: Seek feedback on proposed timeline Feb 2013 Repeal NHP - UPLAR December 1, 2013 Manufacturer/Packagers/Label ers 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, 2014 Distributors/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

15. 15 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

16. 16 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

17. 17 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

18. 18 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

19. 19 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