Consultation on VICH GL 30: Pharmacovigilance of veterinary medicinal products: Controlled Lists of Terms, (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, 2006

To Associations

Re: Consultation on VICH GL 30: Pharmacovigilance of veterinary medicinal products: Controlled Lists of Terms, (Step 4)

Dear Stakeholder:

We are seeking your input on the aforementioned Step 4 draft guidance, which was released by the VICH Steering Committee for consultation. The link to the draft guidance document that is posted on the VICH web site is accessible on the VDD Web site¹ for your information and possible comment in accordance with Step 4 of the VICH process.

Since the VICH Web site is in English only, this draft guideline is only 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. It will be translated into French at that time.

All comments forwarded to VDD, as the Government of Canada co-ordinator, will be transmitted to VICH as is, with the disclaimer that the comments 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 stakeholder comments and consider them in developing the Canadian position on this guideline.

Ifyour organization choosesto provide comments through anaffiliated organization in the U.S., Europe or Japan for input directly to VICH, we would appreciate receiving a copy.

Comments should be submitted to VDD no later than December 31, 2006, in order to allow sufficient time for their assessment and subsequent transmission to the VICH. Comments should be directed to:

Isabelle Caron
Public Involvement Officer
Strategic Planning and Stakeholder Relations
Veterinary Drugs Directorate
Tower A, Ground Floor
14-11 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://www.emea.europa.eu/pdfs/vet/vich/64701-Rev.1.pdf