14th 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 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.
Products of interest:
- Medroxyprogesterone acetate, depot injection 150 mg/ml, in 1-ml vial
- Depot-medroxyprogesterone acetate (DMPA-SC), subcutaneously administered injection 104mg/0.65mL.
- mifepristone 200 mg tablet (only to be used in combination with misoprostol)
- mifepristone 200 mg tablet co-packaged with 4 tablets of misoprostol 200 micrograms.
- Benzathine benzylpenicillin 2.4 million units per dose in vial for reconstitution and intramuscular injection.
All submissions must reach the UNFPA reception in Copenhagen by Monday, 30 July 2018, at 17.00h (Copenhagen time).
|http://www.unfpa.org/resources/reproductive-health-medicines||UNFPA Quality Assurance Policy|
|https://extranet.who.int/prequal/||WHO PQT website|