The Difference between a Class I, II and III NHP Monographs Application in 2023

The Difference between a Class I, II and III NHP Monographs Application in 2023

nhp, nnhpd Introduction:

Identifying the correct application type has become increasingly 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 NNHPD 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 is 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 the most restrictive of the 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. 

The Natural and Non-Prescription Health Products Directorate (NNHPD) has created monographs to ensure the safety, efficacy, and quality of natural health products. These monographs provide important guidelines for product claims and labeling, as well as manufacturing standards for these products.

What is the NNHPD Monograph?

The Natural and Non-Prescription Health Products Directorate (NNHPD) Monograph is a set of rules and regulations for the manufacture, composition, claims labeling, safety, and efficacy of natural health products. It outlines the procedures for evaluating ingredients and manufacturing standards, as well as product claims and labeling. It also helps to ensure that these products are safe, effective, and of high quality.

How to Read and Interpret the NNHPD Monograph Regulations?

The NNHPD Monograph contains specific regulations for natural health products. It is important that you understand how to read and interpret these regulations before using the monograph for guidance. Knowledge of the meaning and purpose of each section, such as ingredients, composition, claims, labeling, and safety, can help you better identify what type of product is compliant with the Monograph requirements. Additionally, understanding how to evaluate whether a product meets these requirements will help ensure that your natural health products are safe to use.

What are Non-medicinal Ingredients?

Non-medicinal ingredients are substances that originate from plant or mineral sources. These substances may be added to a health product to improve its appearance, taste, stability, or ability to absorb other ingredients. For example, vitamin E (tocopherol) and certain carotenoid pigments may be used as non-medicinal ingredients. The NNHPD monograph will provide specific information regarding which non-medicinal ingredients are acceptable for use in a given formulation.

What are Quality Control Requirements for NNHPD Monographs?

Quality control requirements for NNHPD Monographs help to ensure the quality of the ingredients and the product manufactured from them. The monographs generally include a description of acceptable manufacturing methods, tests to be performed on each batch, and analytical requirements to ensure that the active ingredients are present in sufficient quantities and meet specific purity levels. It is important to adhere closely to these requirements to ensure the safety and efficacy of the finished product.

Why are NNHPD monographs important?

NNHPD monographs are important because they provide a standardized set of guidelines for the safety, efficacy, and quality of natural health products. They help ensure that products on the market are safe for consumers to use and that they meet certain quality standards. Monographs also provide valuable information for healthcare professionals, who can use them to make informed decisions about which products to recommend to their patients. Overall, NNHPD monographs play a crucial role in protecting public health and ensuring the safety and effectiveness of natural health products in Canada.

What are the regulatory requirements for NNHPD monographs?

NNHPD monographs are subject to strict regulatory requirements in Canada. They must be based on scientific evidence and meet certain quality standards. Monographs must also be updated regularly to reflect new research and changes in the natural health product industry. In addition, manufacturers of natural health products must comply with the regulations set forth by Health Canada, which include requirements for product labeling, packaging, and advertising. Failure to comply with these regulations can result in fines, product recalls, and other penalties.

How to use NNHPD monographs in product development and marketing?

NNHPD monographs can be a valuable resource for manufacturers of natural health products. They provide guidance on the safety, efficacy, and quality of ingredients commonly used in these products. By using monographs as a reference, manufacturers can ensure that their products meet regulatory requirements and are backed by scientific evidence. Monographs can also be used in marketing efforts to educate consumers about the benefits of natural health products and the scientific evidence supporting their use. However, it’s important to note that monographs are not a substitute for clinical trials or other forms of scientific research.

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