Health Canada Consultation on Drug Submissions
May 6, 2009No CommentsHealth 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.
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