Guidelines on variations to a registered veterinary pharmaceutical product (VPP) approved through EAC mutual recognition procedure (MRP)
No Thumbnail Available
Date
2021
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
East African Community
Abstract
A registered Veterinary Pharmaceutical Product (VPP) Marketing Authorization Holder (MAH) is responsible for the registered product throughout its life-cycle irrespective of the regular reviews by NRAs. The MAH is required to consider technical and scientific progress and therefore changes may be required to the registered VPP over time. The MAH may also wish to alter or to improve the VPP or to introduce an additional safeguard.
Regulation of pharmaceutical products is, therefore considered dynamic, taking into account that changes to the original dossier that was used for registration of the VPP may become necessary during the lifetime of the product. Any changes to a registered VPP, i.e., variations, whether administrative or substantial, are subject to approval by NRAs.
Description
Guidelines on variations
Keywords
Citation
East African Community. (2021). Guidelines on variations to a registered veterinary pharmaceutical product (VPP) approved through EAC mutual recognition procedure (MRP). East African Community.