We have received notice that the Natural and Non-prescription Health Products Directorate (NNHPD) will initiate a new policy with respect to post-licence audit failures.
The NNHPD implemented a new three-class system for the processing of natural health product (NHP) applications in December 2013. This included the ability for companies to attest to meeting Pre-Cleared Information through attesting to their product meeting an established monograph. At the same time, the NNHPD also implemented an auditing system to verify the compliance of these attestations.
The NNHPD reports an audit failure rate of 36%, which has remained constant despite its outreach efforts to applicants and stakeholder associations. NNHPD’s intent is to move towards a defined outcome for failed attestation audits, such as the immediate suspension or cancellation of a product licence that is found to be issued on the basis of a false attestation.
Please note that as of Monday, November 9, 2015, the NNHPD will begin issuing section 19 Suspension Notices in response to audit failures. The section 19 notice will clearly outline the reason for the suspension and its recipient will be afforded 90 days to demonstrate that the situation giving rise to the suspension did not exist, or has been corrected. If this is demonstrated, the suspension will be lifted. If an adequate response is not received within the 90-day timeline, a section 20/21 Cancellation Notice will be issued, and the Natural Product Number (NPN) will be cancelled.
The change in approach still maintains an opportunity for applicants to correct the issue and retain their NPN issued, but with a different outcome if an adequate response is not received (i.e. the cancellation of the product licence).
Going forward, dicentra will continue to ensure due diligence is performed when evaluating ingredients during the application process so that we are confident our clients are properly attesting to the relevant monographs.
If you do receive a Section 19 Suspension Notice, please be assured dicentra will be ready to assist you in responding quickly to the NNHPD so that you keep your product licences.
How Can We Help?
Health Canada consulting is a core set of services offered at dicentra. Health Canada is responsible for overseeing all regulatory and compliance aspects for natural health products, foods, medical devices and cosmetics. As new technologies, products and processes are developed the regulatory landscape must consistently evolve to remain current and modern. At dicentra we pride ourselves on being knowledgeable and up-to-date on the regulations and are proud to participate in government working groups to provide recommendations on pending regulations.
We offer a wide range of services to assist both large and small company’s gain a footing in the health and personal care market place. With over ten years experience, we are a well trusted company that can advise you on changes in Health Canada’s regulations that will specifically impact your business. We are known for providing valuable perspectives on market placement, claims and regulatory compliance while always making sure to be mindful of your bottom line.
We are also continuing our quarterly regulatory updates this 2016 beginning in March to help industry stay up to speed on all of these important developments, as well as any regulatory matters pertaining to health products, supplements, cosmetics and drugs in both Canada and the United States. To learn more please visit www.regulatoryupdates.com. Feel free to call us directly at 1-866-647-3279.