Natural Health Products

An NPN or Product Registration is required for sale in Canada.

New Canadian regulations came into effect on January 1, 2004.  The Natural Health Product Directorate (NHPD) requires that all Natural Health Products obtain a Natural Product Number (NPN) before they can be sold in Canada.

This body is responsible for issuing product licenses for all NHPs and uses evidence submitted by applicants to critically assess the safety, efficacy and quality of NHPs prior to approving them for sale in CANADA.  A Product License Application form must be completed by applicants who wish to sell their products in Canada.

Let us work for you. Ask for a consultation.

  • Do you need to research an ingredient or formulation?
  • Do you have an NPN or Exemption Number?
  • Do you have a formulation but are not sure if you are eligible to receive an NPN?
MCS Associates have the experience and expertise to help you through these issues regarding Natural Health Products quickly and efficiently. We do it right the first time.

MCS Associates Inc. provides the following services:

  • Preparation of evidence reports based on scientific literature search, review and analysis that support the product's health claim(s).
  • Preparation of Safety Summary Reports based on scientific literature search, review and analysis.
  • Careful scrutiny and submission of full text articles of scientific and clinical studies supporting the product's efficacy and safety.
  • Preparation of Quality Summary report stating the final product specifications, including the identity, purity, potency and quantity of the medicinal ingredients, and describing the unit process operations and the in-process quality control points used during manufacture.
  • Pertinent official product registration forms. E-Submissions are an efficient way to submit the Product License Application and obtain submission number or NPN number.
    MCS utilizes the electronic submission system which provides quicker turn around for the submission number or NPN number. Electronic submission reduces the possibility of the application being rejected or refused due to embedded rules while checking for specific regulatory requirements.
  • Full finished product testing through qualified third party laboratories licensed with Health Canada.
  • Combination Rationales is an essential component of the PLA submission as it explains why combining ingredients at their respective quantities in likely to be safe and efficacious within the context of the recommended conditions of use.

In order to comply with NHPD’s submission requirements, MCS Associates Inc. performs comprehensive literature searches across various medical databases to evaluate critically the evidence on the safety and efficacy of your ingredients. When required, we perform our own analyses, and we research and prepare “Combination Rationales” for multi-ingredient submissions.

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Natural Health Products

A Natural Health Product is defined as a substance, or a combination of substances, described in Schedule 1 of the Natural Health Products Regulations, a homeopathic medicine or a traditional medicine, that is intended to provide a pharmacological activity or other direct effect in :
  • The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans.
  • Restoring or correcting organic functions in humans.
  • Modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
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