Health products policy and standards
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Prequalification

All prequalification guidance texts

Related documents

20 April 2020

TRS 1025 - Annex 9: World Health Organization/United Nations Population Fund Prequalification Programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices

10 October 2017

TRS 1003 - Annex 3: Prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies

17 November 2016

TRS 996 - Annex 8: Collaborative procedure between WHO Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines

9 October 2014

TRS 986 - Annex 5: Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities

10 October 2013

TRS 981 - Annex 3: WHO guidelines on variations to a prequalified product

10 October 2012

TRS 970 - Annex 4: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part

10 October 2011

TRS 961 - Annex 10: Procedure for prequalification of pharmaceutical products

10 October 2010

TRS 957 - Annex 6: Guidelines on the requalification of prequalified dossiers

10 October 2009

TRS 953 - Annex 4: Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products