6.1 A legally binding agreement under which access
to information within an original Basic Approval is granted could
include:
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.1 name and address of the person to whom the
Basic Approval rights are being shared;
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.2 identification of each item of Basic Approval
data being shared including:
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.1 the name of the Active Substance and Preparation
or item of data;
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.2 whether the agreement is an exclusive use agreement,
and, if so, when the period of exclusive use protection expires;
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.3 the name of the person or laboratory that conducted
the study;
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.4 a statement that the applicant and approval
holder understand that any false statement may be punishable under
international, national or local legislation; and
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.5 the names, signatures and titles of the applicant
and the approval holder, and the date signed;
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.3 in addition, the approval holder should submit
to the Administration a notarized statement affirming that the person
signing the agreement is authorized by the approval holder to bind
the applicant.
6.2 The manufacturer seeking to use the Basic
Approval for a BWMS that makes use of an Active Substance or Preparation
for the purpose of Final Approval, should ensure that all relevant
international, national and local legislation has been complied with.