Procedure to submit an Expression of Interest (EOI) for Product evaluation to Expert Review Panel (ERP) prequalification team: World Health Organization (WHO), Geneva
Expression of Interest is an Application which is submitted for Product Evaluation to the Expert Review Panel Prequalification Team World Health Organization (WHO) which evaluates the application along with the supporting documents and ensures that the Active Pharmaceutical Ingredients (API’s) and Finished Pharmaceutical Products (FPPs) are safe to use and all the studies w.r.t the safety and efficacy of the product had been completed.
2. Expert Review Panel, WHO Prequalification Team: Medicines, Information Note [Internet]. WHO; 2019 Feb 08 [cited 2020 Jan 08]. Available from:
3. 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 [Internet]. WHO; 2018 Jun 18 [cited 2020 Jan 06]. Available from:
4. WHO Technical Report Series, No. 1010, 2018, Annex 10: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. [Internet]. WHO; 2018 [cited 2020 Jan 07]. Available from:
5. WHO Technical Report Series, No. 970, 2012, Annex 4, 3.2.P.8: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; 2012
6. Requirements for Stability Studies of Finished Pharmaceutical Products, WHO Prequalification Team: Medicines, Guidance Document- [Internet]. WHO; 2010 Mar 29 [cited 2020 Jan 12]. Available from:
7. Recommended comparator products: Reproductive Health medicines, WHO Prequalification Team: Medicines, Guidance Document 14 July 2018 [Internet]. WHO; 2018 Jul 14 [cited 2020 Jan 08]. Available from:
8. FPPs & APIs Eligible for Prequalification ("EOIs") [Internet]. WHO; 2020 [cited 2020 Jan 08]. Available from:
9. Investing In WHO Prequalification of Finished Pharmaceutical Products; Information for Manufacturer; World Health Organization. [Internet]. WHO; 2013 [cited 2020 Jan 08]. Available from:
10. Flow chart for Prequalification Procedure [Internet]. WHO; 2020 [cited 2020 Jan 08]. Available from: https://extranet.who.int/prequal/content/prequalification-procedures-and-fees-0
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