Guideline on the technical documentation required to be included in a registration dossier for an immunological veterinary product
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Date
2021
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Publisher
East African Community
Abstract
This document is intended for use by applicants developing immunological veterinary products for registration within the East African Community (EAC). This Guideline GL2 has annex I for the annotated GL2 version 3 for applicants intending to submit application for (Foot and Mouth disease) FMD vaccine.
The information provided in this document is intended to provide guidance to the applicant in generating the appropriate data for inclusion in a registration application dossier. It is intended to facilitate the interpretation and application of the EAC legislation concerning the sale and supply of immunological veterinary products within the East African Community.
Description
Guideline on the Technical Documentation
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Citation
East African Community. (2021). Guideline on the technical documentation required to be included in a registration dossier for an immunological veterinary product. East African Community