Prequalification of Active Pharmaceutical Ingredients - Disclaimer

Disclaimer

By submitting an application for prequalification the applicant understands and agrees to the conditions of the active pharmaceutical ingredient (API) prequalification procedure, as outlined in the WHO Technical Report Series TRS953, Annex 4.  A summary of the key conditions is outlined below. 

Inclusion in the list of prequalified APIs does not constitute a WHO endorsement or warranty of fitness of the API for a particular purpose, including its use in a particular finished pharmaceutical product (FPP) and the safety or efficacy of that FPP in the treatment of specific diseases.  It remains the ultimate responsibility of the manufacturer of the FPP to ensure that the API, as accepted in principle, is suitable for the manufacture of the specific pharmaceutical product. 

The decision to list an API is based upon information available to WHO at the time of assessment.  This decision is subject to change should new information become available to WHO.  If serious safety or quality concerns arise in relation to a prequalified API, WHO may delist the API or suspend the API until results of further investigation become available and are evaluated by WHO.

Applicants are required to communicate to WHO any changes in manufacture and control that may have an impact on the safety, efficacy and quality of their prequalified API.  It is the applicant's responsibility to provide WHO with the appropriate documentation to prove that any intended or implemented change will not have an impact on the quality of the API that has been prequalified. 

WHO reserves the right to terminate evaluation of a specific application if the applicant is unable to provide the required information, or is unable to implement any corrective actions that WHO may require within a specified time period, or if the information supplied is not adequate for completion of the prequalification procedure.  

As WHO is responsible for the quality assessment of the API, ownership of all related assessment reports lies with WHO.  Thus, WHO shall be entitled to use and publish such reports, subject always to the protection of any commercially-sensitive, confidential information of the manufacturer. Notwithstanding the foregoing, WHO reserves the right to share full evaluation reports and inspection reports with the relevant authorities of any interested Member State of WHO or any other United Nations agency.