Drug Submission Application for:Human, Veterinary, or Disinfectant Drugs and Clinical Trial Application/Attestation
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The attached Drug Submission Application form is designed to assist manufacturers
and sponsors in submitting information required to initiate the evaluation
of any one of the following types of submissions:
- Clinical Trial Application (human drugs)
- Clinical Trial Application Amendment (human drugs)
- Investigational New Drug Submissions (veterinary drugs)
- New Drug Submission
- Supplemental New Drug Submission
- Abbreviated New Drug Submission
- Supplemental Abbreviated New Drug Submission
- Notifiable Change
- Drug Identification Number (DIN) Application
- Administrative Change (only applies to manufacturer/sponsor and/or
product name change and licensing agreements).
The attached Guidance Document provides instructions on
each field of the form. Please read it in its entirety prior to completing
the form.
For Drug Identification Number applications, a separate
completed HC/SC 3011 must be provided for each formulation, strength and
dosage form. For all other submission types, only a separate completed
Part 2 must be provided for each formulation, strength and dosage form.
Note: Additional or supplementary information
for a submission already filed need only be accompanied by a copy of the
letter from Health Canada requesting additional information.
Shaded areas are for Health Canada (HC) use only.
Where to send Drug Submission Applications
Human Drugs:
Clinical Trial Applications and Amendments
must be sent directly to the applicable Directorate
(see attached Guidance Document for addresses)
All other drug submission types are to be
sent to:
Submission and Information Policy Division
Therapeutic Products Directorate
Finance Building, No. 2
Tunney's Pasture
Address Locator: 0201A1
Ottawa, Ontario K1A 1B9 Fax: (613) 941-0825
Veterinary Drugs:
All veterinary drug submissions (including
Investigational New Drug Submissions and amendments) are to be sent to:
Veterinary Drugs Directorate
Holland Cross Tower A
11 Holland Avenue
Address Locator: 3000A
Ottawa, Ontario K1A 0K9 Fax: (613) 946-1125
This page does not form part of the application
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