There has never been a more urgent time to enter the Canadian market with your natural health product (NHP).
For those in the know, you may be aware that Health Canada introduced a “Self-Care Proposal” in September 2016 to align the regulations of self-care products (natural health products, cosmetics and over-the-counter drugs) that is destined to shake up the industry. The Proposal has since become cemented into a framework that is expected to be finalized for consultation by 2020, resulting in changes that would make the present time the best time for moving forward with any natural health product submissions that you have been thinking about.
1). Applications filed at the present time are free. That’s right, there is no Health Canada fee for submissions filed now. However, once the new Self-Care Framework is in place, the NNHPD will be introducing cost recovery for product license application submissions.
2) Timelines now are shorter and more predictable for products that align with a single or combination of monographs. Under the current 3 Class system, compendial applications (products attesting to a single monograph) receive a product license in 10 business days, and products composed of a combination of monographs (Class 2 products) receive a license in 30 calendar days. These timelines are set to change as NNHPD updates their Management of Product License Applications Guidance document, anticipated to be released in the Fall of 2018, which will seek to increase the NNHPD’s review time.
| Application Type | Present time | Following Updated Management of Product License Application Guide |
|---|---|---|
| Class 1 (Compendial; single monograph) |
10 business days | 60 calendar days |
| Class 2 (Combination of monographs) |
30 calendar days | 90 calendar days |
3) Amendments are not yet required for licensed Class 1 products. At the present time for any Class 1 product that has a product license indicating “as authorized in the NNHPD monograph(s) to which the applicant attested”, amendments are not required to be filed with the NNHPD for specific changes that still meet the monograph to which you attested. However, under the updated Management of Product License Application guide, you will be required to file these changes, and more importantly, the review times will align with the review times for submissions. Meaning certain changes that previously had no pre-approval time, will now take 60, 90 or 210 calendar days! (With the timeline dependent on the change being made.)
4) Reduction in information request notices (IRNs) – I know, I know, this sounds like a great thing, less requests for information from the NNHPD! However, the flip side of this coin is that NNHPD intends to reduce the number of IRNs issued, with some exceptions, to a maximum of 2 IRNs, so that they can meet their performance targets. This means that when you file, you need to have the application right the first time as there will be less chance to provide information during the review before you are told to try again. So, let dicentra help you get your application right the first time.
5) Only electronic (web-based) applications will be accepted in the future. Under the proposed changes, applications will only be able to be filed using a web-browser type application that has yet to be debuted. If you have an innovative product that won’t fit the mold of a one-size-fits-all form (eg. kits), there’s no time like the present to file your submission.
If you have been thinking of launching your natural health product line in Canada or extending an existing time, there has never been a better time to move forward. Contact us today!
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries. We can be reached at 1-866-647-3279 or info@dicentra.com.