In May 2013, the Natural Health Products Directorate (NHPD) released the Quality of Natural Health Products Guide (Revised Guidelines), an updated guidance document intended to assist industry in complying with their product quality obligations under the Natural Health Products Regulations. The Revised Guidelines replace the Evidence for Quality of Finished Natural Health Products (guidelines effective June 2007-May 2013) and signal another step by the NHPD in their “new approach” to NHPs, which is aimed in part at reducing unnecessary administrative burdens to bringing safe products to market. The Natural Health Products regime in Canada has seen a marked turnaround in the efficiency and consistency of product licence application review in the last year. A new risk-based approach adopted by the NHPD streamlines the review process for established, low-risk ingredients and products, where safety and efficacy support is well-documented. Under this new approach, relatively more NHPD resources are allocated to the regulatory review of products with higher relative risk. The Revised Guidelines affirm that the risk-based approach extends to the review of the product quality component of licence applications as well. As a result, quality elements that most directly relate to a product’s safety and efficacy will receive the bulk of NHPD scrutiny during review. The Revised Guidelines are more notable still for their acceptance of increasingly flexible means of meeting quality requirements, providing that: Licence holders can substitute, modify or exclude any requirements specified in this guidance, provided that scientific rationales are documented and maintained. These rationales should be based on Good Manufacturing Practices (GMP), scientific principles and product history and experience. It is clear that the Revised Guidelines represent a shift of the onus for quality compliance away from the NHPD and to the licence holder/applicant. This approach provides a more rational and efficient regulatory process for marketers of established product ingredients to navigate in the pre-market period. However, it is coupled with a higher expectation that compliance will be maintained post-market. For example, licence holders are responsible for ensuring that their product specifications are in accordance with the Revised Guidelines, that all quality information is documented, available and sufficient to support the quality of their NHPs, and that the most recent version of the product specifications is submitted to the NHPD. Notably, licence holders are expected to achieve compliance with the Revised Guidelines within the shorter of 12 months, or on production of the next product lot/batch. Summary by: John Lucas

E-TIPS® ISSUE

13 11 20

Disclaimer: This Newsletter is intended to provide readers with general information on legal developments in the areas of e-commerce, information technology and intellectual property. It is not intended to be a complete statement of the law, nor is it intended to provide legal advice. No person should act or rely upon the information contained in this newsletter without seeking legal advice.

E-TIPS is a registered trade-mark of Deeth Williams Wall LLP.