Therapeutic Goods Act 1989

The Secretary or a person authorised in writing by him or her to give certificates under this section may certify in writing that, at a specified time, or at all times during a specified period:

there was no exemption in effect under section 18 or 18A in relation to particular therapeutic goods; or

a person was not exempt under subsection 32CA(1) in relation to a particular biological or there was no exemption under subsection 32CA(2) in relation to a particular biological; or

there was no exemption in effect under section 32CB in relation to a particular biological; or

there was no exemption in force under section 41GS in relation to a particular kind of medical device; or

particular medical devices were not exempt devices;

there was no approval under subsection 19(1) or authority under subsection 19(5) granted to a particular person in relation to particular therapeutic goods; or

there was no approval under subsection 32CK(1) or authority under subsection 32CM(1) granted to a particular person in relation to a particular biological; or

there was no approval or authority in effect under section 41HB or subsection 41HC(1) granted to a particular person in relation to particular medical devices;

there was no approval under subsection 41HD(1), (1A) or (2) granted to a particular person in relation to particular medical devices; or

there was no approval under section 19A granted to a particular person in relation to particular therapeutic goods; or

there was no approval under subsection 32CO(1), (1A) or (2) granted to a particular person in relation to a particular biological; or

particular therapeutic goods were or were not included in the Register as registered goods; or

particular therapeutic goods were or were not included in the Register as provisionally registered goods; or

particular therapeutic goods were or were not included in the Register as listed goods; or

a particular biological was or was not included in the Register; or

particular medical devices were or were not medical devices of a kind included in the Register; or

particular medical devices were suspended from the Register; or

particular therapeutic goods were included in the Register subject to conditions including those specified in the certificate; or

the registration, listing or inclusion in the Register of the particular therapeutic goods had been suspended or cancelled; or

there was no declaration under section 7 which applied to particular therapeutic goods; or

there was no determination under section 7AA which applied to particular goods; or

a person was or was not the holder of a licence in force under Part 3‑3; or

the licence is subject to conditions including those specified in the certificate; or

there was no exemption in effect under subsection 34(1) that applied to particular therapeutic goods or a particular class of therapeutic goods; or

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:

the manufacture of particular therapeutic goods;

a particular step in the manufacture of particular therapeutic goods;

the manufacture of a particular class of therapeutic goods;

a particular step in the manufacture of a particular class of therapeutic goods; or

there was no conformity assessment body determination in force in respect of a particular Australian corporation; or

a conformity assessment body determination was in force in respect of a particular Australian corporation and the determination:

was of general application; or

was limited to the extent specified in the certificate; or

a conformity assessment certificate has been issued relating to a particular kind of medical device; or

a conformity assessment certificate was subject to conditions including those specified in the certificate under this section; or

a conformity assessment certificate was suspended.

A certificate under subsection (1) may relate to more than one of the matters referred to in paragraphs (1)(a) to (o).

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.

In proceedings for:

an offence against section 14 or 41MA; or

the contravention of section 14A or 41MAA (civil penalty provisions);

the Secretary did not consent to the importation, supply or exportation that is the subject of the proceedings; or

the Secretary consented to that importation, supply or exportation subject to conditions specified in the certificate;

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.

In proceedings for:

an offence against a provision of section 41QA, 41QB, 41QC or 41QD; or

the contravention of subsection 41QA(3), 41QB(3), 41QC(10) or 41QD(4) (civil penalty provisions);

the Secretary did not consent to the manufacture, supply or possession that is the subject of the proceedings; or

the Secretary consented to that manufacture, supply or possession subject to conditions specified in the certificate;

In proceedings for an offence against this Act or a contravention of a civil penalty provision, a document purporting to be a certificate given under this section is, unless the contrary is proved, taken to be such a certificate and to have been duly given.