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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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Prequalified Manufacturers

 

Lists of manufacturing sites that have successfully completed the UNFPA/WHO prequalification process:

The prequalification process determines whether the applicant/manufacturer meets the minimum requirements detailed in the relevant ISO standards and WHO/UNFPA Specifications. Under review are product quality, safety, production and quality management.

Please note that all prequalified manufacturing sites are subject to re-qualification every three years for continuous quality monitoring. The lists are updated if there are any changes in the status of manufacturing sites, and when new manufacturing sites or products become prequalified. 

Prequalification Fees

UNFPA Prequalification assessment and retention fees came into force in 2019. The introduction of the Prequalification fee scheme is intended to ensure the sustainability of UNFPA prequalification programme.

Note: UNFPA purchases Hormonal Contraceptives and Maternal Health Medicines that are WHO Prequalified. Please refer to the UNFPA Quality Assurance Policy for Medicines for detailed information on qualifications for procurement. 

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Quality Alert
Dongkuk Viet Nam Co., Ltd. (15/03/2019)

 

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

 

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

Resources 

Annex 9: WHO/UNFPA Prequalification Programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices
Annex 10: WHO/UNFPA technical specifications for male latex condoms
Annex 11: WHO/UNFPA specifications for plain lubricants

TCu380A IUDs  

Female Condoms
 

Infographics