Monograph attestation form

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

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Primary brand name(s):

Application type

Product licence application

Product licence notification

Post-licence amendment

Attestation conditions

When submitting a product licence application in respect of a natural health product for which one or more Natural Health Products Directorate (NHPD) monographs exist in the Compendium of Monographs:

  1. I attest that the information provided in this product licence application [proper name(s), common name(s), source material(s), route(s) of administration, dosage form(s), use(s) or purpose(s), dose(s), duration of use, risk information, etc.] respects the information contained in one or more NHPD monograph(s);
  2. I attest that the non-medicinal ingredients in the product are present and compliant with the Natural Health Product Ingredients Database (NHPID) and do not exhibit pharmacological effects, do not have any effect contradictory to the product's recommended purpose, do not exceed the minimum concentration required for the formulation, do not adversely affect the bioavailability, pharmacological activity or safety of the medicinal ingredients, and that they are safe;
  3. I attest that the label text is acceptable as per sections 86-94 of the Natural Health Products Regulations and the information on the label text is identical to the information provided in this product licence application;
  4. I attest that the natural health product's brand name(s) submitted in this product licence application is consistent with my product licence application, does not pose a risk to health and safety, and is not false and misleading;
  5. I fully understand that I must comply with the conditions of this attestation. Upon receipt of a product licence, if the conditions of this attestation are not appropriately reflected on the product licence, I agree to immediately notify the NHPD;
  6. I fully understand that if I were to operate outside of this attestation that I will be subject to compliance and enforcement, which could include additional requests for safety data pursuant to section 16 of the Natural Health Products Regulations, direction to stop sale pursuant to section 17 of the Natural Health Products Regulations, or suspension or cancellation of my product licence pursuant to section 18 or 19 of the Natural Health Products Regulations; and
  7. I accept any liabilities that may arise out of selling a product outside of the conditions of this attestation for which a product licence was issued based on this attestation.

My product licence application solely contains information that is supported by NHPD Monograph(s) information and the above conditions apply to the application in its entirety; OR

My product licence application contains a combination of information supported by NHPD Monograph(s) and that for which I have provided both safety and efficacy evidence that I wish to undergo review. The here signed attestation applies to the following medicinal ingredients and recommended use/purposes as listed on the product licence application form.

Medicinal ingredients:

Recommended use/purpose(s):

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Name (Print)

Company

Position

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Date (yyyy/mm/dd)

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