![]() For non-medicinal ingredients and purposes not listed as acceptable by the NHPD, the applicant should provide the name, purpose, quantity and associated safety information. Not all of the non-medicinal ingredients (and their associated purposes) normally found in products that have TPD Category IV Monographs or Labelling Standards are captured in the current NHPD List of Acceptable Non-medicinal Ingredients and Non-medicinal Ingredient List of Purposes. the recommended dose according to the monograph is 0.05-0.2 mL, 3x/day but the dose is 0.5 mL, 3x/day) may be submitted as an application as a non-traditional product. ![]() peppermint oil), but has a recommended dose higher than the dose listed in the Compendium of Monographs (i.e. For example, a product containing only one medicinal ingredient that has a monograph (i.e. If a product does not meet the requirements of a NHPD monograph, Therapeutic Product Directorate (TPD) Category IV Monograph (TPD CAT IV) and a TPD Labelling Standard (LS), it can be submitted as an application as a non-traditional product. glucosamine and chondroitin) would be considered a non-traditional application since a NHPD monograph for the combination is not found within the Compendium of Monographs. For example, a product containing two medicinal ingredients with both ingredients having a NHPD monograph (i.e. In cases of combination products that contain medicinal ingredients that have NHPD Monographs, applicants may cite the relevant NHPD monograph to support the safety and efficacy of that particular medicinal ingredient. ![]() For an example of a completed product licence application form refer to Appendix 2 of this guidance document.įor products for which applicants wish to make a non-traditional claim, scientific evidence supporting the safety and efficacy of the product according to the recommended conditions of use must be submitted. Refer to the Evidence for Safety and Efficacy of Finished Natural Health Products guidance document for additional information on the safety and evidence requirements for products with a traditional claim. more than one medicinal ingredient), traditional evidence should be submitted to support the use of this combination or the use of all of the components of the formulation within a single healing paradigm. When the application is for a combination product (i.e. Pharmacopoeia of the People's Republic of China, or State Drug Standard). To make a traditional use claim, the method of preparation should be considered to be traditional and a minimum of two traditional references should be submitted supporting the recommended conditions of use or one acceptable Pharmacopoeial reference (e.g. The NHPD considers a traditional claim to encompass products that have been used within a cultural belief system or healing paradigm for at least 50 consecutive years. Quality Summary Report (including finished product specifications) Reference must meet criteria outlined in Appendix 7 of the Evidence for Safety and Efficacy of Finished Natural Health Products guidance document Pharmacopoeia of the People's Republic of China, or State Drug Standard) is required. ![]() Only one approved pharmacopoeial reference (e.g. Reference to the TPD Labelling Standard or Category IV monograph in cover letter Photocopied and underlined evidence from at least one homeopathic reference to support the recommended use or purpose of each medicinal ingredient.įor each medicinal ingredient, a photocopy of the monograph from the pharmacopoeia to which the applicant attests. Note that abstracts will not be accepted as key references however they may be included in addition. Minimum of two pieces of evidence to support product (e.g. Photocopy the relevant pages, including cover page Minimum of two traditional references (e.g. Also a copy of the most recent version of the label approved by the Therapeutic Products Directorate.Īttest to NHPD Monograph from the Compendium of Monographs. ![]()
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