Draft Guidance Document - Release of draft revised: Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions

Health Canada is pleased to announce the release of the draft revised Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions for a 60-day consultation period. Once final, it will replace the 2006 Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions.

How to Get Involved

This consultation is open for comment starting August 12, 2014 until October 11, 2014. 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 Canada
1600 Scott Street
Holland Cross, Tower B
2nd floor, Address Locator 3102C5
Ottawa, ON  K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812

Consultation Document

Interested parties are encouraged to provide comments and suggestions by October 11, 2014.

Reporting to Canadians

Health Canada will make the results of this consultation available.

If you have any questions, contact us at Bureau of Policy, Science and International Programs.