October 2019
This morning our Natural Health Industry woke up to New Regulations told to us by our industry lawyer, Shawn Buckley. It is very important for people to know of these warnings and upcoming regulations. Please read this link
Changes in our industry!
Health Canada Natural and Non-prescription Health Products Directorate has updated its regulations regarding how applications for natural health products are assessed and ultimately how a license is granted.
Some of you may be aware that Health Canada has introduced a Self-Care Proposal to support the new regulations of natural health products . The first phase began in the fall of 2018 and the second in early 2019 and focused on proposed amendments to the Food and Drug Regulations, and the third phase is and expected to be finalized for discussion by 2020. Health Canada will accept public comments on the proposed changes of the last phase of the updates.
In 2020, Health Canada plans to propose further regulatory changes that will address evidence standards for health claims, extending risk-based, Health Canada oversight, and pursuing additional powers for Health Canada. These additional powers may include, among other things, the ability to require a recall or label change, product name change, formula changes, disallowing claims for certain self-care products.
As the potential risk of the product increases, more oversight would be applied, including fines, mandatory labelling changes and requests to withdraw a product license.
The regulatory changes are intended to balance the levels of Health Canada’s oversight and risk to consumers, as well as help consumers make more informed decisions when selecting and using self-care products.
Some additional updates to watch for….
New product license applications are now required when filing with the NNHPD. The new application form is a web-based license application. It is designed to be completed online and saved where it can be retrieved and /or amended at any time. The form can automatically access the Natural Health Products Ingredients Database (NHPID). e-PLA 2.3.1
A Company Code is now mandatory on the new application form
The company code is a unique number which is assigned to an individual company by the NNHPD. On the Applicant page, the company code must be the one assigned to the applicant/licensee.
NNHPD Performance timelines to issue an NPN have been updated with extended wait times:
Class I is for products that are supported entirely by Individual NNHPD Monograph – now 60 days
Class II is for supported entirely by a combination of Individual NNHPD Monographs – now 90 days
Class III is for products without any ingredients not supported by an NNHPD Monograph – now 210 days or 6 months