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Fps user guide eng USER GUIDE Published by authority of the Minister of Health Health Products and Food Branch User Guide COur mission is to help the people of Canada maintain and improve their health Health Canada HPFB s Mandate is to take an integrated

USER GUIDE Published by authority of the Minister of Health Health Products and Food Branch User Guide COur mission is to help the people of Canada maintain and improve their health Health Canada HPFB s Mandate is to take an integrated approach to the management of the risks and bene ?ts to health related to health products and food by Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food and Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health Health Products and Food Branch Minister of Public Works and Government Services Canada Available in Canada through Health Canada - Publications Brooke Claxton Building A L A Tunney's Pasture Ottawa Ontario K A K Tel - Fax - Également disponible en français sous le titre Manuel de l ? utilisateur CHealth Canada FOREWORD Finished Product Speci ?cations Form User Guide User Guides are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations User Guides also provide assistance to sta ? on how Health Canada mandates and objectives should be implemented in a manner that is fair consistent and e ?ective User Guides are administrative instruments not having force of law and as such allow for exibility in approach Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scienti ?c justi ?cation Alternate approaches should be discussed in advance with the relevant program area to avoid the possible ?nding that applicable statutory or regulatory requirements have not been met As a corollary to the above it is equally important to note that Health Canada reserves the right to request information or material or de ?ne conditions not speci ?cally described in this guide in order to allow the Department to adequately assess the safety e ?cacy or quality of a therapeutic product Health Canada is committed to ensuring that such requests are justi ?able and that decisions are clearly documented This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guides or guidance documents CHealth Canada Finished Product Speci ?cations Form User Guide TABLE OF CONTENTS INTRODUCTION Policy Objectives Scope and Application GUIDANCE FOR IMPLEMENTATION Completing the FPS form Recognized Test Methods APPENDIX Finished Product Speci ?cations form APPENDIX Acceptable Tolerance limits for Quality Test Parameters CHealth Canada INTRODUCTION Finished Product Speci ?cations Form User Guide Policy Objectives This guide is intended to explain the new approach to submission of Finished Product Speci ?cations for Product Licence Applications Scope and Application This guide applies to the submission of all non- compendial pre-market submissions of Natural Health Products that fall under the NHP regulations This document should be read in conjunction with the Evidence for Quality of Finished Natural Health Products guidance document GUIDANCE FOR IMPLEMENTATION The NHPD has developed