1. Health Canada’s Approach to Low Risk Veterinary Health Products: Interim Notification Pilot Program Veterinary Drugs Directorate-Health Canada Presented to the VICH Outreach Forum October, 2015

2. Health Canada/Veterinary Drugs Directorate Mandate Health Canada is responsible for protecting human and animal health and the safety of Canada's food supply. Through the Veterinary Drugs Directorate, Health Canada evaluates and monitors the safety, quality and effectiveness, sets standards and promotes the prudent use of veterinary drugs administered to food-producing and companion animals. http://www.hc-sc.gc.ca/dhp-mps/vet/index-eng.php 2

3. Health Canada/Veterinary Drugs Directorate Act, Regulations & Guidelines Food and Drug Regulations Food and Drugs Act The Veterinary Drugs Directorate (VDD) applies the Food and Drug Regulations under the authority of the Food and Drugs Act international guidelines Data requirements according to international guidelines for veterinary drugs VICH VICH 3

4. Health Canada/Veterinary Drugs Directorate HC-VDD website: http://www.hc-sc.gc.ca/dhp- mps/vet/index-eng.phphttp://www.hc-sc.gc.ca/dhp- mps/vet/index-eng.php Note: Health Canada does not have authority over the practice of veterinary medicine (Provincial jurisdiction) 4

5. Veterinary Drug Regulation/Approval Current process Pre-market approval requirements: Manufacturing and quality controls Animal safety data Efficacy data Human safety data (Food producing animals) http://www.hc-sc.gc.ca/dhp- mps/vet/legislation/guide-ld/vdd-guide-ands-padn- eng.phphttp://www.hc-sc.gc.ca/dhp- mps/vet/legislation/guide-ld/vdd-guide-ands-padn- eng.php 5

6. Low-risk Veterinary Health Products Issues (1) Increased demand Increased demand for low-risk veterinary health products such as vitamins, minerals, homeopathics, probiotics and botanical products among others challenges Members of the industry faced challenges in meeting current regulatory requirements (not adapted to these products) Drug regulatory framework – one size fits all, regardless of risk 6

7. Low-risk Veterinary Health Products Issues (2) without regulatory scrutiny A number of these products marketed or imported for sale in Canada without regulatory scrutiny or appropriate market authorization unknown to Health CanadaQuality, safety and efficacy unknown to Health Canada compliance actionRegulatory compliance action in Canada / at the border 7

8. Interim Notification Pilot Program: New Option simplified registration2012: A voluntary option of simplified registration for Low- Risk Veterinary Health Products for companion animals low risk products only Health Canada sets standards - low risk products only Notification Number Notified products have a Notification Number on label (ex. NN.1A2B) not prioritize the enforcement Health Canada would not prioritize the enforcement of the regulatory requirements for such products 8 4

9. Interim Notification Pilot Program: Development (1) industry and science experts Standards developed in consultation with industry and science experts Recommendation of the Expert Advisory Committee (2010) INPP consultation - strong stakeholder support (2011) Flexible approach to product regulation Reduction of administrative burden for Industry 9

10. Interim Notification Pilot Program: Development (2) Administrative process Administrative process in collaboration with third party administrator Customized Database, e-forms List of Admissible Substances List of Admissible Substances Researched over 5500 ingredients (vitamins, minerals, homeopathic, herbal, excipients etc) Harmonization Harmonization Information from other directorates, agencies (eg NHPD, CFIA, Food) and international resources (eg US GRAS, EU directives) 10

11. Interim Notification Pilot Program Design (1) cats, dogs and horses Only for products intended for use in cats, dogs and horses Great interest from stakeholders on an approach for food producing animals pre-cleared ingredients Only pre-cleared ingredients oral /topical/otic Only oral /topical/otic (ear) route of administration general health claims Only general health claims 11

12. Interim Notification Pilot Program Permitted claims General Health Claims maintenance Refer to the maintenance of normal physiology, not to its modification “Helps maintain”, “supports”, “enhances”, “has a role in”, “contributes to” disease, condition or injury Not associated with a specific disease, condition or injury Structure or physiological function “Maintains joint and bone health” vs “Treats osteoarthritis” 12

13. Interim Notification Pilot Program Design (2) Health Canada Health Canada sets eligibility standards (Safety, Efficacy, Quality) Sponsor Sponsor attests to compliance (evidence on hand) Third Party Program administered by Third Party verifies eligibility issues NNs on fee-for-service basis 13

14. Interim Notification Pilot Program: Outcomes(1) 700+ 642700+ Notified Products since March 2012 (642 active) 53255325 ingredients permitted with qualifications ~3800 Homeopathic ~750 Non-Medicinal ~135 TCM ~640 Active (plant, animal, chemical) 14

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16. Interim Notification Pilot Program: Outcomes(2) custom madeUse of custom made software Database and e-forms- Product Notification, New Substance Application and Adverse Event reporting (interconnected) TestedTested and fine-tuned registration model Potential to be expanded to food producing animal products in the new regulatory framework 16

19. Interim Notification Pilot Program: Benefits (1) safety 1. Increased general safety Low risk ingredients only Knowledge of manufacturing site (traceability/recalls) Proper labelling/manufacturing standards Adverse event reporting In/out system (Regulations still apply) 19

20. Interim Notification Pilot Program Benefits (2) Increased access 2. Increased access to Low-risk products for animals Easier/faster process - reduced requirements/less costly Low priority for regulatory compliance enforcement by Health Canada 20

21. Interim Notification Pilot Program: Benefits (3) burden 3. Reduced burden and cost for client Simple registration process Reduced requirement for evidence data time to market 4. Reduced time to market for new products 1-4 weeks vs 300 days for conventional products resources 5. No increase in government resources Administration by third party 21

22. Interim Notification Pilot Program: Summary Reduced administrative and financial burden on Industry without compromising health and safety of Canadians and animals 22 15

23. Interim Notification Pilot Program: More info www.lrvhp.ca or http://www.hc-sc.gc.ca/dhp-mps/vet/issues- enjeux/notification-declaration-eng.php 23