Guidance Documents

Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats
June 2010, Version 2.0

• This guidance document outlines the principles and considerations to be applied in determining if a product in a food format is a natural health product. It has been created and published with a view to achieving greater consistency, transparency and quality of classification decisions relating to products in food format. It is intended to be used in conjunction with other existing guidance documents and policies.
  

Product Licensing
December 2006 - version 2.0

• Important Notice -- Licensing of NHPs with DINs
  
  This guidance document outlines what a product licence is, when it is required, who must hold one, how to apply for one and how to change one, as well as the requirements for the labelling of all natural health products and how these requirements can be met. It also describes the process applications go through when they reach the Natural Health Products Directorate, and includes samples of all the necessary forms.

Post Licensing
December 2007 - Version 1.0

Once a Natural Health Product has been granted a Product Licence (NPN or DIN-HM), it is not uncommon for licensees to make changes to the product; such changes are referred to as post-licensing changes. A post-licensing change is any change that is made to a licensed natural health product pursuant to section 7 and 11 or 12 of the Natural Health Products Regulations. This guidance document provides information on the different types of post licensing changes as well as recommendations for licencees on how to submit the required documentation to Health Canada.

Evidence for Safety and Efficacy of Finished Natural Health Products
December 2006 - version 2.0

This guidance document provides the information to help product licence applicants determine the evidence (amount and type of data) required to support the safety and efficacy of finished natural health products. The NHPD allows any combination of the natural health product substances listed in Schedule 1 to the Natural Health Products Regulations, as long as there is no concern regarding safety and there is a sound rationale for the combination. For information on combination products please see section 8.0 of the Evidence for Safety and Efficacy of Finished Natural Health Products guidance document.

Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products)
October 2006

These Guidelines are intended to provide advertisers with the tools to understand drug advertising principles before advertising copy is considered and submitted for review to an advertising preclearance agency which has publicly attested to meeting the attestation criteria established by Health Canada . The Guidelines form the basis upon which advertising preclearance agencies review and approve advertising for nonprescription drugs, including natural health products, and will help ensure consistency in advertising review.

Evidence for Homeopathic Medicines
May 2007- version 2.1

The Natural Health Products Regulations (the Regulations) require all homeopathic medicines to have a licence before being sold in Canada. Licence holders are issued a product number which must appear on the label of their product. The product number for homeopathic medicines is preceded by DIN-HM. To obtain a DIN-HM, a Product Licence Application (PLA) form must be completed by applicants.

• HM Labelling Standard

Applicants seeking a product licence for HMs with non-specific health claims are eligible for expedited review by attesting to the HM Labelling Standard. Similar to a monograph, the HM Labelling Standard was created to facilitate the licensing of certain types of HMs which correspond to the parameters and requirements set out in the standard.

Evidence for Quality of Finished Natural Health Products
September 2007 - Version 2.0

The document outlines the quality technical requirements and to assist applicants in preparing the quality summary report and to ensure effective and efficient review process. The Natural Health Products Directorate (NHPD) uses the evidence submitted by the applicant to critically assess the quality (identity, purity, quantity and potency and tolerance limits) of the finished natural health products prior to sale in Canada.

Labelling
August 2006 - version 1.0

The purpose of this guidance document is to help product licence applicants interpret the labelling and packaging requirements specified in Section 5 of the Natural Health Products Regulations when selling a natural health product within Canada. Included in this guidance document are labelling and packaging requirements, the labelling and packaging system, special labelling requirements and presentation of the product information on the label.

Master File Procedures
August 2006 - Version 1.0

A Natural Health Product Master File (NHP-MF) is a mechanism that would enable a manufacturer of a medicinal ingredient/ raw material to provide proprietary information on their product directly to the Natural Health Products Directorate (NHPD) without disclosing the information to the applicant. The NHP-MF mechanism is applicable to medicinal ingredients, non-medicinal ingredients, (packaging material and safety and efficacy evidence data) in support of Product Licence Applications or Clinical Trial Applications. Cross-reference can be made to NHP-MFs by one or more manufacturers (as long as an authorization letter from the Master File originator (holder) is provided to NHPD in advance or provided along with the product licence application).