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Consultation on the Release of a draft revised Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation

Health Canada is pleased to announce the release of a draft revised Drug Submission Application 3011 form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation. The draft revised 3011 form is available for comment(s) on the Health Canada Web site.

The revision was undertaken to respond to numerous requests from stakeholders to reduce the number of individual forms requesting similar information. The draft revised 3011 form amalgamates the following Health Canada forms: Drug Submission Application Form 3011, Drug Product Information Form (DPIF), Schedule A Form for Nonprescription Products, Animal Tissue Form for Category IV and the Animal Tissue Form for Labeling Standard.

The majority of the information requested in the original forms now being merged has been carried over into the draft revised 3011 Form. The draft revised 3011 form incorporates a new section on the use of nanotechnology in drug products. Definition of nanotechnology used by Health Canada is also included in the guidance document.

How to Get Involved

This consultation is open for comment starting May 1, 2009 until June 15, 2009. Please select and read through the link below titled "consultation document". Once read, please submit your comments via email to John Johnson, fax or by mail to:

Submission and Information Policy Division
Finance Building
101 Tunney's Pasture Driveway
Address Locator: 0201A1
Ottawa, Ontario
K1A 0K9

Fax: 613-941-0825

Consultation Document: To obtain a copy of the draft form that was consulted upon, please contact SIPDMAIL@hc-sc.gc.ca.

Interested parties are encouraged to provide comments and suggestions by June 15, 2009.

Reporting to Canadians

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

If you have any questions, contact John Johnson.