For the purpose of this guidance, the definitions in Procedure
(G9) apply and:
2.1
"Applicant" means any manufacturer
or developer working with the Member State or Administration, in the
development of a BWMS that intends to use the original Basic Approval
for a certain Active Substance in the development of the BWMS.
2.2
"Substantially similar" in relation
to "use" of an Active Substance or Preparation means the method of
application and point of injection of the Active Substance or Preparation
to the BWMS are not significantly different to that in the system
granted approval.