Document ID: chunk:federal_register_of_legislation:C2024C00632:section:56a:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 56A (pt 2/3)
Character Range: 1102854–1105688

there was no declaration under section 7 which applied to particular therapeutic goods; or
 (ha) there was no determination under section 7AA which applied to particular goods; or
 (i) a person was or was not the holder of a licence in force under Part 3‑3; or
 (j) the licence is subject to conditions including those specified in the certificate; or
 (k) there was no exemption in effect under subsection 34(1) that applied to particular therapeutic goods or a particular class of therapeutic goods; or
 (l) there was no exemption in effect under subsection 34(2) that applied to a particular person in relation to one or more of the following:
 (i) the manufacture of particular therapeutic goods;
 (ii) a particular step in the manufacture of particular therapeutic goods;
 (iii) the manufacture of a particular class of therapeutic goods;
 (iv) a particular step in the manufacture of a particular class of therapeutic goods; or
 (la) there was no conformity assessment body determination in force in respect of a particular Australian corporation; or
 (lb) a conformity assessment body determination was in force in respect of a particular Australian corporation and the determination:
 (i) was of general application; or
 (ii) was limited to the extent specified in the certificate; or
 (m) a conformity assessment certificate has been issued relating to a particular kind of medical device; or
 (n) a conformity assessment certificate was subject to conditions including those specified in the certificate under this section; or
 (o) a conformity assessment certificate was suspended.
 (2) A certificate under subsection (1) may relate to more than one of the matters referred to in paragraphs (1)(a) to (o).
 (3) In proceedings for an offence against this Act or a contravention of a civil penalty provision, a certificate under subsection (1) is prima facie evidence of the matters specified in the certificate.
 (4) In proceedings for:
 (a) an offence against section 14 or 41MA; or
 (b) the contravention of section 14A or 41MAA (civil penalty provisions);
a certificate by the Secretary to the effect that:
 (c) the Secretary did not consent to the importation, supply or exportation that is the subject of the proceedings; or
 (d) the Secretary consented to that importation, supply or exportation subject to conditions specified in the certificate;
is prima facie evidence of the matters specified in the certificate.
 (4A) In proceedings for the contravention of subsection 19D(3) or (4) or 32BF(6) (civil penalty provisions), a certificate by the Secretary, to the effect that the Secretary did not consent to the importation or supply that is the subject of the proceedings, is prima facie evidence of the matters specified in the certificate.
 (4B) In proceedings for:
 (a) an offence against a provision of section