Notice - Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation

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Notice

June 16, 2010
Our file number: 10-112583-799

Health Canada is pleased to announce the release of the revised Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation. The revised Health Canada 3011 form and accompanying instructions replace the previous form.

Effective immediately, sponsors should use this revised form. The form and instruction document are now available on the Health Canada website.

The draft version of the Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation and instruction document was released for comment on May 1, 2009, for a period of 45 days. A total of 33 comments were submitted on topics varying from formatting changes to additional clarification for some of the instruction fields. A copy of the tabulated summary of comments is available to stakeholders upon request.

Based on feedback from stakeholders on the revised document and internal discussions, several changes have been made to the final version of the form and instruction document.

Questions or additional clarifications about this document should be directed to:

Submission and Information Policy Division (SIPD)
Therapeutic Products Directorate
Health Canada
Finance Building
101 Tunney's Pasture Driveway
Address Locator: 0201A1
Ottawa, Ontario,
K1A 0K9

Facsimile: 613-941-0825
Email: SIPDMail@hc-sc.gc.ca