Consultation on VICH guideline 51: Statistical evaluation of stability data (step 4) - letter to stakeholders

Veterinary Drugs Directorate
Health Products and Food Branch
Ground Floor, Suite 14
Holland Cross Complex
11 Holland Avenue
Ottawa, Ontario K1A 0K9
Postal Locator 3000A

December 15, 2011

To Associations,

Re: Consultation on VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products) guideline 51: Statistical evaluation of stability data (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We are seeking your input on the aforementioned  Step 4 draft guidance, which was released by the VICH Steering Committee for consultation. The link to the draft guidance document that is posted on the VICH web site is accessible on the Veterinary Drugs Directorate (VDD) website for your information and possible comment in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 implementation in Canada (step 7).

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 United States, Europe or Japan for input directly to VICH, the VDD would appreciate receiving a copy.

Comments should be submitted to VDD no later than January 31, 2012, in order to allow sufficient time for their assessment and subsequent transmission to the VICH. Comments should be emailed to consultationVDD-DMV@hc-sc.gc.ca or mailed to:

International Liaison Officer
Veterinary Drugs Directorate
Health Products and Food Branch
Ground Floor, Suite 14 - Holland Cross Complex
11 Holland Avenue
Ottawa, Ontario K1A 0K9
Postal Locator 3000A

Thank you for your cooperation in this matter.

Yours Sincerely,

Veterinary Drugs Directorate