Imminent Changes to the Current Canada Natural Health Product (NPN) Licensing timelines

In October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process.  It brought a streamlined and predictable timeline when NPNs would be issued (prior to this, there was a massive backlog of applications, NPNs sometimes took several years go be issued and many companies were selling natural health products before an NPN Health Canada was issued, utilizing the submission number as an equivalence to authorization where Health Canada was not enforcing the regulations of NPN Health Canada requirements to sell an NHP).

It was anticipated that the number of NHP applications would decrease since this policy came into effect.   Though class 2 and 3 application volume has been steady, the number of class 1 applications has been significantly increasing.  Given the size of the Canadian retail market and the number of Natural Health Products available on the market, in theory, a saturation point should have been met.  There are several reasons for this volume increase, particularly for class 1.  One reason is our trade partner to the south.  The US economy is hot, unemployment levels are at record lows and recent corporate tax cuts have fueled business growth and expansion.  Naturally, the next destination for many US companies in Canada given its similar culture, buying power, and a higher per capita consumption of health and wellness products than in the United States.  Another reason is the exportation.  Here at Quality Smart Solutions, we’ve had a number of clients in the past few years who are obtaining NPNs (mostly class 1) for the sole purpose of exportation.  Certain countries take the NPN as an equivalency to their regulations which helps expedite approval and distribution in the respective jurisdiction.

Since fall 2017 we have noticed performance targets, particularly for some class 3 applications being missed.  This missed timeline has been a few weeks to 2 months past the performance target deadline!  These were the first signs that NNHPD’s resources were stretched and they couldn’t keep up with the inflow of applications.   The goal was to ensure the quality of applications reviewed remained consistent and performance targets were met.

The proposed NHP Management of Applications Policy Update includes the following:

Performance Service Standard

Class 1:

10 business days

Class 2:

30 calendar days

Class 3:

30 calendar days for screening + 180 calendar days to review

Class 1:

60 calendar days (target of 30)

Class 2:

90 calendar days (target of 45)

Class 3:

210 calendar days

IRNAs little as 2 days to respondAs little as 5 days to respond
Post License AmendmentNot required for Class 1 if changes are within monograph scopeChanges required for all products aligning with NHPR Sections 11 & 12
Submission optionsPaper by mail, ePost or DVD/CD by mailePost or DVD/CD by mail

A proposed Electronic Product License Amendment and Notification Form (PLAN) will be created to ensure data captured is in a consistent format.

It is anticipated this new policy update of NPN Health Canada will be published in fall 2018 and fully implemented by the end of the year.

Now is the time to submit your class 1 and 2 Natural Health Products under the current service standard timelines!  Quality Smart Solutions can conduct a comprehensive review of your Natural Health Product and determine what classification your product will fall under.  Licensing, Labelling, and Importer of Record.  We are your end-to-end solution provider.  Contact us today!

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