Prequalification of Active Pharmaceutical Ingredients - Information related to a prequalified finished pharmaceutical product (FPP)

What if the APIMF has already been submitted in relation to a prequalified FPP?

The evaluation of an APIMF submitted for API prequalification can be abbreviated by referring to an already accepted APIMF.

If the APIMF has been accepted in support of a prequalified FPP it is not anticipated that full assessment of this APIMF will be repeated.  Such APIMFs will be reviewed only for key information and conformity with administrative requirements.  Nonetheless, it is possible that a request for further information will be made in order to ensure the APIMF meets all current norms and standards and the Programme reserves the right to do so.

If the API manufacturer wishes to refer to an APIMF accepted in support of a prequalified FPP then the details of this APIMF and the details of the APIMF submitted for prequalification must be identical.  The referred to APIMF should be formatted as required for API prequalification.  If this is not the case, an updated APIMF should be submitted at the time of application. An abridged assessment will still occur. 

If the APIMF accepted for a prequalified FPP and the APIMF proposed for API prequalification differ technically, then a revised APIMF should be submitted at the time of the application together with a summary of changes document.  An abridged assessment may still be possible.

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