Description
Pharmacovigilance of veterinary medicinal products (VMPs) can be defined as the detection and investigation of the effects of the use of these products, mainly aimed at safety and efficacy in animals and safety in people exposed to the products. This document will only deal with the spontaneous reporting system for identification of possible adverse events following the use of marketed VMPs.
Scope & Applicability
Product Classes
1The guidance applies to residual solvents in these products
Stakeholders
3Professional providing oversight for antimicrobial drug use; Veterinarian is to determine the actual duration that the drug will be used; Professional ordering the duration of use for antimicrobial drugs
Bodies that accept clinical trial data and grant marketing authorizations.
Entity responsible for managing the submission of PBRERs
Regulatory Context
Attributes
1Date of the first marketing authorization for same or similar product granted in any VICH region.
Related CFR Sections (3)
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR514.3§ 514.3 Definitions.
The definition and interpretation of terms contained in this section apply to those terms as used throughout subchapter E.Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- CVM GFI #231 Distributor Labeling for New Animal Drugs (Status: Final)
- CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting (Status: Final)
- CVM GFI #240 Proprietary Names for New Animal Drugs (Status: Final)
- CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances (Status: Final)
- CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)