Summary

Amends the:

to: clarify the powers, functions and duties of Commonwealth officials and authorities within the Commonwealth-State cooperative scheme for the regulation of therapeutic goods (as a consequence of the High Court’s decision in R v Hughes); enable the implementation of the mutual recognition agreement entered into between Australia and Singapore relating to the manufacture of medicines; provide for implementation of other similar mutual recognition agreements; enable collection of information and documents in relation to blood and blood component manufacturing processes and practices; clarify the timeframe for payment of evaluation fees; and allow the Minister to impose conditions for the listing of goods on the Australian Register of Therapeutic Goods; and to reflect new administrative and financial arrangements required as a result of changed portfolio responsibilities; and proposed , if it commences after this proposed Act, in relation to the definition of “conformity assessment certificate”.