means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time.

means an attestation of conformity (within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment body that is approved by the Secretary in writing.

means a Conformity Assessment Body designated in one of the following Sectoral Annexes to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement:

means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time.

has the meaning given by section 41CA.

means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are

means:

means a medical device that is of a kind that is exempted from Division 3 of Part 4 ‐ 11 by the regulations.

, in relation to a provision of Part 3 ‐ 3, means therapeutic goods that are exempted from the operation of that Part by the regulations.

, in relation to therapeutic goods, means a person exempted from the operation of Part 3 ‐ 3 in relation to those goods by the regulations.

means a biological that is:

means a medicine that:

means the Federal Circuit Court of Australia.

means the Federal Court of Australia.

means a financial corporation within the meaning of paragraph 51(xx) of the Constitution.

has the meaning given by section 52A.

means a foreign corporation within the meaning of paragraph 51(xx) of the Constitution.

means a group of kits identified in an order in force under subsection 16(3A).

has the meaning given by subsection 16(2).

, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include: