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?
evaluation of an APIMF submitted for API prequalification
can be abbreviated by referring to an already accepted
APIMF has been accepted in support of a prequalified FPP it
is not anticipated that full assessment of this APIMF will
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.
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.
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.