NHP Application Consulting to obtain NPNs

NHP Application Consulting services: Natural Health Products / Dietary Supplements to obtain NPNs

NHP Application consultant

Also commonly called Product Licence Applications (PLAs)

 

 

What are NHPs (and what are not)?

How are NHPs Regulated in Canada? And Why?

Who do these Regulations Apply to? And Who is exempt?

What is a Product Licence (PL)?

Who must apply for a Product Licence (PL)?

How we can help you with the NHP Application (PLA) process?

Our Literature Search services:

Our Label Development Services:

Formulation Development Services:

nhp Product Licence Application consultantWhat are NHPs (and what are not)?

NHPs are defined as: “substances or combinations of substances consisting of molecules and elements found in nature, and homeopathic preparations, sold in dosage form for the purpose of maintaining or improving health and treating or preventing diseases/conditions”.

They expand the above by including a Function and a Substance component to the definition.

1. The Functional component states that an NHP is one that is used to:

  1. diagnose, treat, or prevent diseases /conditions;
  2. restore or correct organic function;
  3. modify organic functions, such as modifying those functions in a manner that maintains or promotes health;
  4. for sale as an OTC (Over-The-Counter) product; and
  5. for self care and self selection by the public.

2. The Substance component states that an NHP is one that is included in the their database of pre-approved materials list, such as:

  1. a plant or plant material (incl. extracts)
  2. an alga, bacterium or fungus;
  3. vitamins & minerals;
  4. probiotics, amino acids & enzymes; and
  5. essential fatty acids.

3. A NHP includes (but is not limited to):

  1. Traditional Herbal Medicines (THMs);
  2. Traditional Chinese Medicines (TCMs);
  3. Ayurvedic (East Indian) Medicines;
  4. Native North American Medicines;
  5. Homeopathic Medicines (HMs);
  6. Aromatherapy products (which make health claims);
  7. Cosmetics which have bio-active ingredients and/or make health claims; and
  8. Certain Food Supplements or Beverages which contain NHPs (i.e.: sports drinks or coffees containing Echinacea, ginseng, maca, guarana, etc.)

4. What is excluded from the definitions of a NHP?

  1. Drugs requiring a prescription;
  2. Radiopharmaceuticals;
  3. Biologics, such as anterior pituitary extracts;
  4. Injectables; and
  5. Antibiotics.

natural health product label development services

How are NHPs Regulated in Canada? And Why?

Health Canada has created the Natural and Non-prescription Health Products Directorate

“These regulations are intended to provide Canadians with ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity”.

In Canada, NHPs are regulated as a subset of the Drug Regulations. Whereas, similar Dietary Supplements are regulated in the United States as a subset of the Food Regulations (under DSHEA).

NHPs are obliged to meet certain minimum standards for safety and quality with increased standards for Quality Control and Finished Product testing to ensure what is listed on the label is actually in the bottle.

Manufacturers, packagers, importers, and distributors of NHPs located in Canada are obliged to hold valid Site Licenses, which attest to continued compliance with GMP standards specific to NHPs.

Products are evaluated, commensurate with their potential risk.

Product labels will be standardized to be complete, accurate, and informative and must include Warnings, Interactions, Contraindications and Side Effects.

NHPs are allowed to make health claims.

These claims must be supported by reasonable evidence (such as traditional references, scientific publications, professional consensus, or other evidence).

A pre-market approval process is required, prior to marketing the products. This is done via a Product Licence Application

There will be post-market surveillance to monitor the risks and benefits (which is based on the margin of safety of the product and any reported adverse reactions).

Who do these Regulations Apply to? And Who is exempt?

1. The regulations apply to the sale of NHPs in Canada, for human use, and apply only to:

  1.    Fabricators (manufacturers);
  2.    Labellers / Labelers;
  3.    Importers; and
  4.    Distributors of NHPs.

2. Who is Exempt?   The regulations do not apply to:

  1.    Growers, testers & retailers;
  2.    Natural Practitioners, such as Aboriginal Healers who may prepare medicines (as long as the product is prepared for an individual patient only); and
  3.    Suppliers of raw materials (RMs).

Product Licence Application consulting

What is a Product Licence (PL)?

Before an NHP can be sold in Canada, one must first obtain a Product Licence (PL) and therefore must undergo a product review and approval process.

The applicant must provide the NNHPD with an application submission package which must include sufficient evidence to allow them to evaluate all aspects of the Safety, Efficacy and Quality. Fortunately, the NNHPD has many pre-approved ingredient monographs.

The amount and type of evidence required is based on the level of risk of the NHP. Therefore, it will depend upon the amount and type of health claims made, the severity of the symptoms or conditions it purports to treat, and the nature of the ingredients within the NHP

Once approved by the NHPD the product will be given an 8 digit Natural Product Number (NPN), which must be put on the product label. This is analogous to a DIN for drugs, but will be in the form of 8000xxxx.

NHP registration consultant services

Who must apply for a Product Licence (PL)?

The individual / company (whether domestic or foreign) with legal responsibility for the product, must obtain the Product Licence (i.e.: the company whose name is on the label).

How we can help you with the PLA process?

Please refer to our page “Why use a consultant?” i.e.: Why spend a month or longer internally trying to figure out regulatory / QA / labelling requirements, when ICS can most likely provide the solution in only a few days. We can:

  1. Ensure the medicinal ingredients (MIs) are allowed in NHP formulations, and at those dosages.
  2. Ensure the non-medicinal ingredients (NMIs) are on the List of Pre-approved NMIs.
  3. Justify the purpose of each ingredient (MI & NMI) in the formulation.
  4. Ensure the manufacturer meets all of the GMP requirements
  5. Identify the type and category of health claim(s) in the PLA and on the label, such as: risk reduction vs. structure-function (specific vs. non-specific) vs. treatment vs. traditional use vs. non-traditional use.
  6. Locate, then obtain, any additional scientific documentation to support the Safety, Efficacy & Quality – not only for the Finished Product, but also for each individual MI. Please refer to our Literature Search services below.
  7. Ensure the types of documentation used in the PLA are from reputable sources which the NNHPD will recognize.
  8. Create a Quality Summary Report.
  9. Determine the specifications for the finished product, and which methods & equipment should be used
  10. Te format and information within the Certificate of Analysis (C of A)
  11. If required by the NNHPD, create an Efficacy Summary Report for each MI and for the finished product, which explicitly references various scientific literature.
  12. Justifying (in a format acceptable to the NNHPD), the purpose for combining more than one MI into a single product.
  13. Create a Safety Summary Report for each MI and for the Finished Product, which explicitly references various scientific literature and describes:
  14. Risk information, such as required listing of: cautions, warnings, contraindications or known adverse reactions;
  15. Herb-herb, herb-drug and herb-food interactions;
  16. Whether the MIs and/or NMIs interfere with QC or diagnostic tests;
  17. Safe dosage ranges and duration of use;
  18. Additive pharmacological (beneficial) effects of two or more like-acting (or synergistic-acting) MIs in the same product;
  19. Additive adverse reactions due to two or more MIs in the same product;
  20. Performing numerous combinations of calculations to ensure that the additive pharmacological effects clearly outweigh the additive adverse reactions; and
  21. Providing a rationale (in a format acceptable to the NHPD), on how to mitigate any risks associated with each MI or their combination.

Our Literature Search services:

  1. Since we have been working in this industry since 1999, we have a very good idea of what types of literature the NNHPD will find acceptable, and which literature may not be.
  2. Over the years we have purchased numerous reference books which are acceptable to the NNHPD. Therefore, we may have the necessary literature on hand.
  3. We also pay annual subscription fees to various electronic literature sources, which are acceptable to the NNHPD.
  4. Overall, we should not only be able to find literature which is acceptable to the NNHPD, but we should be able to obtain it in a rather efficient manner.

Our Label Development Services:

  1. Identifying acceptable health claims.
  2. Determining the amount of information required within the Risk Information section, such as Warnings, Contraindications with diseases / conditions, Side Effects, and any known Interactions with other NHPs, Drugs or Foods.
  3. Requiring the exact amounts of each Medicinal Ingredient (MI).
  4. Ensuring the label lists all non-medicinal ingredients (NMIs)
  5. Identifying any Allergy warnings.
  6. Ensuring the label information exactly matches the PLA documentation;
  7. Ingredients are listed in the correct order and use of their proper terminology;
  8. Appropriate directions for use;
  9. Correct units for each MI (mg, mcg, IU, mL, mg/mL, etc.);
  10. Determining which marketing / advertising claims are allowed and which ones are not;
  11. Which info must be on the front panel of the label and which info can be on any other panel;
  12. Correct font sizes for each heading on the label;
  13. Which headings and/or statements must be in bold;
  14. Ensuring the proper format & location for the expiry date and lot number;
  15. Which terms or phrases must be bilingual and which ones are optional (refer to our Translation Services); plus
  16. Many other label issues which must also be addressed.

Formulation Development Services:

Since the NHP regulations came out in 2004, we have worked with at least 50-60 organizations attempting to register ~1,000 different NHPs / Dietary Supplements with the NNHPD. Most were successful, but a bunch were not – especially during the first few years when the requirements were extremely rigid. Since about late 2013 – early 2014 they realized their were over-zealous for documentation relating to efficacy, and now have more realistic expectations.

But even given the new reality, we are still given formulations to review by clients, and assess those formulations on the probability of them obtaining an NPN. In various situation, we advise that the present proposed formulation most likely will not succeed. We could simply tell the client that we have no idea until they’ve contracted us to perform the full literature research for efficacy, dosages & safety for each & every medicinal ingredient (MI) in the product, prepare all of the documentation, including drafting the label, submit the PLA to the NNHPD and wait to find out. However, we feel that could be a potential waste of valuable money, a waste of our time, and possibly the client being upset with us.

Therefore, if the formulation is only a proposed / theoretical one, we can often suggest revisions such as replacement of one MI with another; addition of another key MI, or revising the dosage of certain MIs.

Sometimes we see proposed formulations for a specific recommended use / purpose / condition, and scratch our heads as to why certain MIs are in there. In some of those cases, the client responds with “our main competitor’s product has those MIs in their product”. Or, they read something on the internet by some unlicensed naturopath or herbalist discussing it. Or they read that the MI had good success in vitro (test tube, Petri dish), or in vivo (mice, rats). Unfortunately, Health Canada’s NNHPD does not accept that type of evidence – neither for efficacy, nor safety.

Therefore, since the requirements on the types / levels of evidence to support efficacy, MI dosages & safety, are clearly laid out, in these situations we strongly recommend allowing us to create a great formulation for you. i.e.: taking a proposed formulation based on the paragraph above and attempting to obtain an NPN for it may be like trying to “stick a square peg into a round hole“. Our approach, knowing what the NNHPD will/not accept we start from the other end of the process: i.e.: we know which literature (see our Literature Research services above) for specific MIs and their associated dosages, that they will accept, then build a formulation around those. We can then tweak the dosages of each MI, and add other MIs to make the end formulation unique.

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.


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