, in relation to a medical device covered by paragraph 41BD(1)(a), (aa) or (ab), means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable the device to be used as the manufacturer of the device intended.

has the meaning given by section 42U.

, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

means:

(a) a publication specified under paragraph 3AB(3)(a), as that publication is in force from time to time; or

(b) a part of a publication specified under paragraph 3AB(3)(b), as that part is in force from time to time.

has the meaning given by subsection 3AB(1).

has the meaning given by subsection 3AB(2).

means an for approval of the use of a restricted representation in an advertisement about therapeutic goods.

means a fee payable under subsection 41LA(3).

, in relation to a restricted representation, means the person to whom notice of approval of the use of the restricted representation was given.

means the distinguishing number allocated to an approved advertisement by the Secretary under regulation 5J of the Therapeutic Goods Regulations.

means an advertisement:

(a) approved under regulation 5G, or taken to be approved by the Secretary under subregulation 5H(2), or approved by the Minister on review under regulation 5M, of the Therapeutic Goods Regulations; and

means:

(a) a conformity assessment fee; or

(b) an application audit assessment fee;

payable under Part 410.

means an Australian corporation that is the subject of a conformity assessment body determination made under the regulations.

means a certificate that is issued by an Australian conformity assessment body and that is of a kind mentioned in section 41FIA.

means the Agreement on Mutual Recognition in Relation to Conformity Assessment, Certificates And Markings between the Government of Australia and the Government of the United Kingdom of Great Britain and Northern Ireland, as in force from time to time.

means a quantity of a product that is:

(a) uniform in composition, method of manufacture and probability of chemical or microbial contamination; and

, in relation to therapeutic goods, means the quantity and characteristics of microorganisms present in the goods or to which the goods may be exposed in a manufacturing environment.

has the meaning given by section 32A.

of a biological means:

(a) the number assigned to the biological under subsection 32DB(2), 32DF(2) or 32DN(5); or