7.3.1 Granting equivalence and exemption from
the prescriptive rules rests solely with the Administration. This
has the implication that risk assessments and assumptions made, scenarios
applied and the original basis of the risk profile to evaluate the
alternative features are to be submitted from the previous to the
new Administration, including any subsequent revisions.
7.3.2 The new Administration will examine the
documentation, and will decide if it is acceptable.
7.3.3 The new Administration may request an independent
validation of prerequisites, original parameters and review of the
risk profile to verify whether the original parameters still hold
and the originally applied criteria remain acceptable.