Draft Guidance Document - Human-Use Antiseptic Drugs

Notice to the reader: The online consultation is now closed. The final guidance document 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. The content found on this page is a snapshot of the live consultation as it was presented to the public during the consultation period.

This guidance applies to antiseptic skin products for human use and intended for use in professional and commercial settings. The guidance is applicable to pharmaceutical antiseptic products (both Division 1 and Division 8) as well as to natural health antiseptic products. The guidance will outline the categories of antiseptic products, the filing process for antiseptic submissions, the basic documentation required for all categories of antiseptic products covered in the guidance, and the additional detailed data recommendations for specific claims.

How to Get Involved

This consultation is open for comment starting November 26, 2008 until February 6, 2009. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

Policy_Bureau_Enquiries@hc-sc.gc.ca

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch Inspectorate
Holland Cross, Tower B, 2nd Floor
1600 Scott Street,
Address Locator # 3102C5
Ottawa, Ontario,
K1A 0K9

Fax: 613-941-1812

Consultation Document: To obtain a copy of the draft guidance document that was consultated upon, please contact Policy_Bureau_Enquiries@hc-sc.gc.ca

Interested parties are encouraged to provide comments and suggestions by February 6, 2009.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at Policy_Bureau_Enquiries@hc-sc.gc.ca