WHO/IVB/05.19
Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies
The document provides guidance to manufacturers and regulatory authorities about the procedure in place at WHO to assess the acceptability, in principle, of vaccines purchase to UN Agencies. It provides the background information, the purpose of the service to UN agencies, and the details of the procedure followed. It details the steps to be followed, special considerations taken for vaccine fillers, for priority products, for products required on an emergency basis, etc. In adition, it provides in the annexes the required format and contents of the PSF, the model confidentiality agreement and non-conflict of interest form to be signed by experts participating of the assessment.
Size: 603 KB