NHP Licenses

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Product Licenses for Natural Health Products are divided into four categories. Each class of product has different requirements in terms of the information to be submitted at the time of review.

Compendial

These are a specific class of formulations that are typically single ingredient and have well known dosages and clinical indications. This application is simple to prepare and the most economical, however, requires accurate filing to ensure that the application does not get rejected.

Traditional

This class of formulations contain botanical ingredients. These formulations are well described in traditional herbal literature and have dosages and clinical indications that have been traditionally described. Quality and Safety reports must be filed.

Non-Traditional

These formulations are typically more illustrative of contemporary NHP’s on the market. NHP products can have multi-ingredient combinations that may or may not be supported by modern clinical trial evidence efficacy claims. For this classification Quality, Safety and Efficacy reports must be filed.

Homeopathic

The Natural Health Products Regulations require all homeopathic medicines to have a license before being sold in Canada. License holders are issued a product number that must appear on the label of their product preceded by DIN-HM.

To obtain a DIN-HM, a Product License Application (PLA) form must be completed by applicants. These applications are assessed by the Natural Health Products Directorate (NHPD), which is responsible for issuing product licenses for all Natural Health Products (NHP’s). The NHPD uses evidence submitted by applicants to critically assess the safety,efficacy, and quality of NHP’s prior to approving them for sale in Canada.

The Homeopathic Applications are divided into two categories:

1. Specific Claim Application
2. Non-Specific Claim Application

The Specific Claim Application requires submission of the specific homeopathic evidence to substantiate the efficacy (or claim) of the homeopathic formulations.




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Health Canada

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MCS Associates has 25 years experience in Canadian Regulatory Affairs.

MCS has expertise in Homeopathic products registration

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TYPES OF PRODUCT LICENSE APPLICATIONS
  • Non-Compendial (NHPD) Non-Traditional(single or multi-ingredient submissions)
  • Non-Compendial (NHPD) Traditional Applications
  • Compendial (NHPD Monographed) Applications
  • Homeopathic
  • 1. Specific Claim
    2. Non-Specific Claim
  • TPD
  • 1. Labeling Standard
    2. Category IV Monograph
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