Consultation on VICH GL 3 (R) : Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision), (Step 4)

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Veterinary Drugs Directorate
Tower A, Ground Floor
14 - 11 Holland Avenue
Postal Locator 3000A
Ottawa, Ontario K1A 0K9

November 10, 2005

To Associations

Drugs & Health Products

Re: Consultation on VICH GL 3 (R) : Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision), (Step 4)

Dear Stakeholder:

The aforementioned Step 4 draft guidance was revised at Step 9 by the VICH Steering Committee in October 2005 for consultation and is being linked to the Health Canada's Veterinary Drugs Directorate (VDD) Web site for information and comment in accordance with Step 4 of the VICH process¹.

The VICH Web site is in English only, and consequently, this draft guideline is made available in English. It is important to note that amendments to draft documents may occur as a result of regulatory consultations, and subsequent deliberations within VICH. Once finalized, the VICH guideline will be adopted for technical requirements in Canada and will be translated into French at that time.

All comments forwarded to VDD, as the Government of Canada VICH Secretariat, will be transmitted to VICH as is, with the disclaimer that they are provided for information and do not necessarily represent the views of the Government of Canada, unless specifically indicated in separate comments. VDD will then assess comments received and will consider them in developing the Canadian position on this guideline.

Should your organization choose to provide comments to an affiliate association in the U.S., Europe or Japan for their input directly to VICH, we would appreciate receiving a copy.

Comments should be submitted to VDD no later than December 31, 2005, in order to allow sufficient time for their assessment and subsequent transmission to the VICH. Comments should be directed to:

Marc M. Plante
Public Involvement Officer
Strategic Planning and Stakeholder Relations
Veterinary Drugs Directorate
Tower A, Ground Floor
11 Holland Avenue
Postal Locator 3000A
Ottawa, Ontario K1A 0K9

Thank you for your cooperation in this matter.

Yours sincerely,

Kathy Dobbin
VICH Coordinator and Director of Strategic Planning and Stakeholder Relations

^1. PDF file located at http://vich.eudra.org/pdf/11_2005/GL03_R__ST4.pdf