Consultation on VICH GL 24 : Pharmacovigilance of veterinary medicinal products: management of Adverse Event Reports (AERs), (Step 4)

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

April 11, 2006

To Associations

Re: Consultation on VICH GL 24 : Pharmacovigilance of veterinary medicinal products: management of Adverse Event Reports (AERs), (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We are seeking your input on the aforementioned Step 4 draft guidance, which was released by the VICH Steering Committee for consultation. The link to the draft guidance document that is posted on the VICH web site is accessible on the VDD Web site¹ for your information and possible comment in accordance with Step 4 of the VICH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.

Health Canada is currently developing its own Environmental Assessment Regulations (EAR) to ensure that appropriate environmental management and assessments are conducted on substances in products regulated under the Food and Drugs Act. It is anticipated that the new regulatory regime will be completed by the end of 2006.

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.

If your organization chooses to provide comments through an affiliated 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 June 11, 2006, 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
14-11 Holland Avenue
Postal Locator 3000A
Ottawa, Ontario K1A 0K9
marc_m_plante@hc-sc.gc.ca

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/GL24F_st4.pdf