Removal of Antiretroviral Products from the WHO List of Prequalified Medicines

Information and Guidance for Regulatory Bodies, National AIDS Programmes, Doctors and Patients

Practical implications


In principle, patients should discontinue using de-listed medicines and switch to other prequalified products (see Annex 1). However, in many cases it will be difficult to find alternative prequalified products immediately. In this situation it is recommended that patients continue to use de-listed products, as the risk of interrupting treatment is higher than that of taking medicines whose bioequivalence is not proven but which have otherwise been prequalified. A switch to non-prequalified products is not recommended as their quality has not been documented by WHO.

The patient should be informed that there is no reason to believe continued use of the de-listed products is dangerous, and that suspending the treatment or switching to alternative ARVs whose quality has not been assured is far riskier.