Archive - Summary of Key Changes to the Compendium of Monographs for Natural Health Products

October 2006

The following is a summary of the major modifications made to the Compendium of Monographs for Natural Health Products. A number of smaller revisions and modifications have been made but are not reflected in this summary document. The PDF of the revised guidance document is available at: Compendium of Monographs

Table of Content:

1. List of Unsuitable Dosage Forms

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1. List of Unsuitable Dosage Forms

Quick reference - see following section(s) of the revised compendium:

• Appendix 1 - List of Unsuitable Dosage forms

Further information regarding unsuitable dosage forms has been included in the revised compendium under Appendix 1. This appendix clarifies which dosage forms are unsuitable for compendial product licence applications by outlining which ones require a quality assessment. Applicants are encouraged to refer to this appendix prior to submitting a compendial application.

The addition of this appendix to the Compendium of Monographs will prevent applicants from wrongly identifying their product licence applications as compendial; therefore, decreasing the number of submissions being transferred out the compendial assessment stream.