APVMA not to use information for registration of new chemical product to register a similar product after disclosure
14B APVMA not to use information for registration of new chemical product to register a similar product after disclosure
This section applies if:
information was given to the APVMA in connection with an application made after the commencement of this section for registration of a chemical product (the first product) containing an active constituent that was not a previously endorsed active constituent at the time of registration of the first product; and
the information related to the first product or the active constituent and:
the safety criteria; or
a matter that is prescribed by the regulations; and
the information was disclosed:
by the Commonwealth, a State or a Territory; or
by an authority of the Commonwealth, a State or a Territory (including the APVMA); or
by anyone acting on behalf of the Commonwealth, a State, a Territory or an authority of the Commonwealth, a State or a Territory; and
the information was not publicly available before the disclosure; and
as a result of the disclosure, the applicant for an application for registration of a chemical product (the second product) that is the same as, or similar to, the first product, seeks to have the APVMA use the information in determining the application.
For 10 years after the first day on which the first product was registered, the APVMA must not use the information to register the second product if:
the registration of the second product would be commercially unfair; and
the authorising party for the information does not consent to the use.
The use of information in contravention of subsection (2) for determining the application for registration of the second product does not affect the validity of the registration of the second product.
An action or proceeding does not lie against any of the following for any loss directly or indirectly sustained because of the use of information in contravention of subsection (2):
the Commonwealth;
the APVMA;
a person who is or has been:
a director of the APVMA; or
the Chief Executive Officer of the APVMA; or
a delegate of the APVMA; or
a member of the staff of the APVMA.
This section has effect in addition to Division 4A.
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