Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data

Document ID: APHIS-2010-0098-0001
Document Type: Notice
Agency: Animal And Plant Health Inspection Service
Topics: No Topics associated with this document
Federal Register Number: 2010-26748
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Abstract: The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled "Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data." This draft guideline provides information concerning the development of a single electronic message to transmit adverse event reports concerning veterinary biologics between regulatory authorities in the European Union, Japan, and the United States and marketing authorization holders (veterinary biologics licensees and permittees) in those regions. Because the draft guideline applies to pharmacovigilance and adverse event reporting on veterinary vaccines regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the scope of the guideline and its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee.
Document Subtype: Notice
Received Date: October 22 2010, at 12:00 AM Eastern Daylight Time
Start-End Page: 65293 - 65294
Comment Start Date: October 22 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: December 21 2010, at 11:59 PM Eastern Standard Time

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