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Prequalification Programmes

The Prequalification Programmes were developed by WHO in 2001 to promote and facilitate access to safe, appropriate and affordable health products of good quality in an equitable manner. The management of the prequalification preogrammes for Male Latex Condoms and Copper TCu380A IUDs was delegated to UNFPA in 2005, and the management of the prequalification programme for  Female Condoms delegated to UNFPA in 2006. 

The prequalification programmes follows a systematic process consisting of a detailed technical review of required documentation, on site factory inspections, and product testing. This process determines that the quality of products is in accordance with international standards and WHO/UNFPA specifications and guidelines.

The findings are used to provide independent technical information on safety, quality and performance of the products assessed to other UN agencies, WHO Member States and other interested organizations. The UNFPA/WHO prequalification status, in conjunction with other procurement criteria, is used by these entities to guide their procurement of the products covered by the WHO prequalification programmes.

Detailed information on the prequalification programmes and quality assurance for Male and Female Condoms, TCu380A IUDs, Reproductive Health Medicines and Medical Devices is available online at UNFPA. Further detailed information that highlights key issues relevant to applying a technically sound, systematic process to support the manufacture, prequalification, testing, procurement and distribution of products can be found within the specification guides located in the resources section of this page. 

UNFPA Quality Assurance Policy for Reproductive Health Medicines adheres to the WHO Prequalification Programme for Medicines; SRA approval and WHO Expert Review Panel recommendations.

Note: WHO and UNFPA recommend only procuring male latex condoms, female condoms and IUDs from manufacturing sites who have been prequalified through this process. 

For further information and any questions related to the UNFPA prequalification programme, please contact the Prequalitication Programme team at: psb.prequalification@unfpa.org.

 

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IMPORTANT UPDATES

 
Quality Alert
Dongkuk Vietnam Co., Ltd (15/03/2019)
Update - Dongkuk Vietnam Co., Ltd (25/09/2020)

 

Notice of Suspension
MHL Healthcare Ltd, India  (31/01/2020)

 

Notice of Concern
Nulatex Sdn Bhd  (10/01/2020)

Resources 

Click here to access Resources

Infographics