Notice to Stakeholders - Release of draft Guidance document for consultation: Submission and Information Requirements for Extraordinary Use New Drugs (EUNDS)

February 12^th, 2013

Health Canada announces the release of the draft Guidance document Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs) for a 75-day consultation from February 12^th, 2013 to April 29^th, 2013 inclusive. Health Canada invites all interested stakeholders to submit their feedback during this comment period.

The objective of this draft document is to provide guidance to sponsors to enable them to meet the pre-market and post-market information and regulatory requirements under the Food and Drugs Act and its Regulations for the authorization of extraordinary use new drugs (EUNDs) in Canada.

Process to participate in consultation

1. Obtain document

To obtain the document, please email BGTD.OPIC@hc-sc.gc.ca.
You will receive:

• the draft Guidance; and
• the form in which to submit your comments by section number and line number.

2. Submit comments

To submit comments to Health Canada,
Please email comments to BGTD.OPIC@hc-sc.gc.ca using the form provided. All comments will be considered in the finalization of the document. The 75-day consultation period is from February 12^th, 2013 to April 29^th, 2013 inclusive.

Comments will also be accepted by:

Fax
(613) 952-5364

Mail
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
Address Locator: 0702B
200 Tunney's Pasture Driveway
Ottawa ON K1A 0K9
Canada