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Dec. 4 - Canada: Release of the Final Guidance Document: Human-Use Antiseptic Drugs

Posted Date: 
Friday, December 4, 2009

From Health Canada:

The final version of this Health Canada guidance document Human-Use Antiseptic Drugs is now available. Comments and suggestions received from the consultation on the draft version of the guidance were reviewed and considered in the finalization of this document, and are available upon request.

This guidance applies to antiseptic skin products for human use and is applicable to both pharmaceuticals (both Division 1 and Division 8 ) and natural health products, falling outside the scope of the Category IV Antiseptic Skin Cleanser Monograph for personal domestic use products. Specifically, it covers professional and commercial use antiseptic skin products, as well as non-Monograph personal use products such as those making viral, specific organisms, persistence and/or log reduction claims.

The guidance outlines the categories of antiseptic products, the submission filing process, and the basic documentation required to support product efficacy. It also provides information on test organisms and detailed data requirements necessary to support specific claims and enhanced labelling.

For more information or to read the guidance document on Human-Use Antiseptic Drugs click the link above.

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