Ottawa – Health Canada has amended the Natural Health Products Regulations. For more information and to access the supporting Labelling of Natural Health Products guidance document, visit What’s new: Natural and non-prescription health products.
Foreword
Guidance documents are meant to provide assistance to industry and health care practitioners on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Guidance documents are administrative instruments and therefore allow for flexibility. Alternate approaches to the principles and practices described in this document may be acceptable; licence applicants are invited to discuss these with the Natural and Non-prescription Health Products Directorate (NNHPD) prior to submitting an application.
As a corollary to the above, it is equally important to note that Health Canada may request information or material, or define conditions not specifically described in this document, in order to enable the Department to adequately assess the safety, efficacy or quality of a health product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with the Natural Health Products Regulations and relevant sections of other applicable guidance documents.
Document Change Log
Document: Pathway for Licensing Natural Health Products Used as Traditional Medicines, Version 1.0
Date: December 2012
Replaces: Evidence for Safety and Efficacy of Finished Natural Health Products, Version 2.0
Note: this document is also replaced by the following document: Pathway for Licensing Natural Health Products Making Modern Health Claims, Version 1.0
Date: December 2006
Change: Extensive revisions
Location (section, paragraph): There were extensive revisions to the content including the addition of revised appendices and an extensive reorganization of the document.
Nature of and/or Reason for Change: The December 2006 document, Evidence for Safety and Efficacy of Finished Natural Health Products, Version 2.0, was revised in order to reflect some of the recommendations of the Natural Health Product Program Advisory Committee which were posted on the Health Canada website under the name Report of the Natural Health Products Program Advisory Committee to the Natural Health Products Program, January 26, 2010. It was also split into two guidance documents.