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10th Invitation to Manufacturers of Reproductive Health Medicines to Submit an Expression of Interest (EOI) for Product Evaluation by the WHO Expert Review Panel (ERP) for Reproductive Health Medicine

Sollicitation de Manifestations d'Intérêt

Des informations générales

International
   ERP for Reproductive Health Medicines, UNFPA/DNK/EOI/17/012
   Avr 11, 2017
   Juin 15, 2017
   Eligibility criteria for ERP/RHM review
FPPs are eligible for review by the ERP if the following conditions have been met:
(a) the manufacturer of the FPP has submitted an application for prequalification of the product by the WHO Prequalification Programme or provides written commitment to submit an application within three months from the date of approval into the ERP, and/or
(b) the manufacturer of the FPP has submitted an application for marketing authorization to an SRA, and it has been accepted for review by the SRA, and
(c) the FPP is manufactured at a site that is compliant with the standards of Good Manufacturing Practice (GMP) that apply for the relevant product formulation (as verified after inspections by parties such as, but not limited to, SRA, WHO Prequalification Programme or any inspectorate participating in the Pharmaceutical Inspection Cooperation Scheme (PIC/S)
   Anglais
   Acquisition internationale

Adresse de contact

   Seloi Mogatle
UNITED NATIONS POPULATION FUND United Nations City 51 Marmorvej 2100 Copenhagen Denmark
Danemark
   +45 45337277
   Cliquez ici

Missions

Test et évaluation  

Texte original

      
Background

In 2011, UNFPA’s Executive Board approved a new Quality Assurance Policy for Reproductive Health Medicines. The preferred approaches are for procurement of finished pharmaceutical products (FPPs) that meet the following criteria:
1. FPPs prequalified by the WHO Prequalification Programme or authorized for use by a Stringent Drug Regulatory Authority (SRA) ; or
2. FPPs recommended for use based on advice provided by the Expert Review Panel for Reproductive Health Medicines (ERP/RHM).

Expert Review Panel for Reproductive Health Medicines

The ERP/RHM is an independent technical body composed of external technical experts and hosted by the Unit of Regulation of Medicines and other Health Technologies (RHT) of WHO Department of Essential Medicines and Health Products (WHO/EMP/RHT). The Procurement Services Branch of UNFPA (UNFPA/PSB) provides the Secretariat for the ERP/RHM. The ERP/RHM will be convened by WHO/EMP/RHT and review product dossiers submitted by manufacturers of FPPs that are not yet WHO-prequalified or SRA-authorized, undertake a quality risk analysis associated with the use of those products and provide written advice to the Secretariat to help making evidence based procurement decisions.

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