3.6.1 The Administration reviews the delivered
documentation; states further requirements for documentation if necessary,
can request verification of achieved results and eventually grants
approval.
3.6.2 This means that the Administration needs
to be in a position to assess whether the design has been sufficiently
examined and whether any risks have been reduced acceptably and thus
should have sufficient knowledge of the subject to evaluate the adequacy
of the delivered information and the assumptions made. The Administration
should make the final decision for applying these Guidelines to approve
alternative and/or equivalent design, and the final responsibility
of design approval rests with the Administration.