Has having a natural health product license application just getting accepted into the queue felt like an accomplishment? Have you been waiting on an Application Acknowledgement Letter (AAL) from the Natural and Non-prescription Health Products Directorate (NNHPD) but instead you receive a rejection notice? How did this happen, you crossed all your t’s and dotted all of your i’s and yet you didn’t get the answer you were looking for. Enter the NNHPD’s new Application Management Policy (MAP).
Since the introduction of the new policies associated with the review of Product License Applications (PLAs), the NNHPD has become very strict about administrative requirements – the days of the courtesy call to advise you that your Designated Party Authorization form (DPA) was inconsistent with the NNHPD’s records are over. Instead, you need to be certain that your application has been prepared in accordance with the administrative requirements set out by the NNHPD.
To assist you in putting your best foot forward when it comes to PLA preparation, we have summarized 5 requirements to consider to avoid a rejection notice from the NNHPD.
While we all know a DPA is required if you are submitting an application on behalf of someone else, what you may not know is that if someone else has signed the DPA electronically that will result in a refusal. The DPA form is recognized as a legal document and therefore Health Canada requires it to be hand-signed. What about the electronic signature software we all use these days? Well, that is something to bring up at the next stakeholder meeting.
It’s getting close to the product launch for your new adult multivitamin product and it’s time to register the product with Health Canada. The product contains only ingredients which are supported by the NNHPD’s Multivitamin/mineral Supplements Monograph so the product is eligible to receive a license in 60 calendar days. You submit your application but instead of receiving the license you receive a rejection notice! What was the problem in this process? You followed the steps and checked off the claims on the web-based PLA. The rejection notice and NNHPD has refused the application because the claim “helps in the development and maintenance of bones and teeth (especially in children and young adults)” which includes a reference to a subpopulation that is not captured on your PLA, i.e. children and young adults. A detail that that resulted in a rejection notice!
In the past, the NNHPD used to courteously reclassify your application if they decided your class II submission was actually a class III submission. With the changes to the MAP, this is no longer something they are practicing. Incorrectly classifying your application can result in a refusal. If you have questions on what type of submission you have, reach out to us. The last thing you need is a rejection when your product launch is 3 months away.
The product development team has recently decided they want to take a different approach for your top-selling wellness line. The reformulated products have triggered the need for resubmissions. What’s the easiest way to file a resubmission? Update the existing PLA? I completely agree with you – that is the easiest way but it will result in a refusal. NNHPD requires a new tracking number for each submission. So, unless you diligently saved an unfinalized copy of the PLA before you submitted your application, you are going to have to fill in the PLA form again.
You’ve poured your heart and soul into supporting the safety and efficacy of your class III submission – the claims are novel, the application is submitted, and you’re feeling great until you receive the rejection notice and realize you forgot to send the full-text reference with your submission. NNHPD requires submission of all supporting evidence in order to deem the submission complete.
This list is just a few things which can earn you a rejection notice from the NNHPD and unfortunately, it is not comprehensive. If you have any questions regarding the registration or marketing of NHPs in Canada, please contact us.
dicentra offers a full range of services to assist with the marketing of compliant NHPs. Whether you’re seeking guidance on which ingredients to choose or to confirm the marketing on your website is compliant, the team at dicentra has the expertise and resources to assist you. We can provide expertise on product and marketing compliance, quality assurance & safety standards, research & development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces.