3.1 The manufacturer seeking to use an original
Basic Approval for a BWMS that makes use of an Active Substance or
Preparation for the purpose of obtaining a subsequent Final Approval
for a BWMS using the same Active Substance or Preparation, should
evaluate the extent to which the BWMS meets the criteria specified
in this guidance document.
3.2 Proof that legal issues have been properly
dealt with should be provided to the Administration by the manufacturer
seeking to use the original approval.
3.3 The Administration having received a submission
to use an original Basic Approval should review the application, taking
into account the guidance in this document. If the Administration
is satisfied that such utilization is acceptable, it should advise
the Organization of its determination as appropriate. The Organization
should circulate the information accordingly.
3.4 The Administration should submit the application
for Final Approval to the Organization, as soon as possible in accordance
with section 8.2 of Procedure (G9).
3.5 If the GESAMP-BWWG agrees that the application
is complete and appropriate, it should proceed to consider the application
for Final Approval of the BWMS.
3.6 If the GESAMP-BWWG finds that the application
is not complete or is inappropriate, (or both), the GESAMP-BWWG should
report their findings, as provided for in Procedure (G9), for consideration
by the Committee.
3.7 Under Procedure (G9), the Committee of the
Organization will make the final decision on whether to accept the
recommendations of the GESAMP-BWWG to reject an approval of any proposal.