Identifying the correct application type has become increasingly more crucial for Natural Health Product (NHP) applications. Incorrect classification can result in detrimental outcomes such as the issuance of rejection notices (RN) and further delays to go-to-market plans.
A basic understanding of the different NHP application classes (Class I, Class II, Class III) can help to better plan for this. Our Experts at Quality Smart Solutions can help you navigate this decision process and understand some of the limitations and benefits each application type offers.
Health Canada currently defines NHP applications as three types of application classes, which are then further subdivided into two application streams: compendial and non-traditional. The compendial application stream is exclusive to Class I applications, while the non-traditional application stream includes Class II and Class III applications.
First, let’s begin by discussing one of the primary points of deciphering application classes: the compendium of monographs. The compendium of monographs is an online repository created by Health Canada for a variety of NHP ingredients. The monograph outlines pre-cleared information (PCI) by Health Canada which is defined as:
- Any form of information supporting the safety, efficacy or quality of a medicinal ingredient or natural health product that the Natural and Non-prescription Health Products Directorate (NNHPD) has reviewed and determined to be acceptable. PCI can be used to speed up the evaluation of the NHP and serves as a reliable source of product information for consumers.
With the monographs as a reference point, the application streams can now be better defined as follows:
- Class I: must comply with all of the parameters of an individual NNHPD monograph with no modifications. Only one NNHPD monograph per application in Class I can be referenced.
- Class II: supported entirely by a combination of 2 or more NNHPD monographs or 1 NNHPD monograph, where slight deviations to claims are permissible.
- Class III: a full assessment required as in the following cases: novel preparations, ingredient master files, ingredient combinations, and going beyond NNHPD monograph parameters
One may ask, what are the main differences between the three? While Class I applications are referencing pre-approved information from Health Canada, it is also is the most restrictive of three but with the shortest application processing time.
Class II applications, by contrast, have greater flexibility than Class I. However, there are still limitations on the extent to which claims can be made. Class II applications have a median application processing time of the three.
Lastly, Class III applications offer the greatest flexibility; however, this also is at the cost of application processing time. Of the three application types, Class III is the longest.
As always, there are exceptions to these general guidelines. In some cases, there may be some exemptions or further restrictions.
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