Consultation on VICH GL 40: Specifications - New Biotechnological / Biological Veterinary Medicinal Products, (Step 4)

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

October 8, 2004

To Associations

Re: Consultation on VICH GL 40: Specifications - New Biotechnological/Biological Veterinary Medicinal Products, (Step 4)

Dear Stakeholders:

We are seeking your input on the aforementioned Step 4 draft guidance, which was released by the VICH Steering Committee for consultation. This draft guidance is linked to the VDD Web site¹ for your information and possible comment in accordance with Step 4 of the VICH process.

This draft guideline is available only 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.

All comments forwarded to VDD, as the Government of Canada co-ordinator, 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.

If your organization choosesto provide comments to anaffiliate 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 January 15, 2005, in order to allow sufficient time for their assessment and subsequent transmission to the VICH. Comments should be directed to:

Dhurata Ikonomi
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

Footnote

1. as a PDF file under
http://vich.eudra.org/pdf/09_2004/GL40-st4.pdf