Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 56A

             (1)  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:

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

                (aaaa)  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

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

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

                    (aa)  particular medical devices were not exempt devices;

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

                  (baa)  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

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

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

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

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

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

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

                  (eaa)  a particular biological was or was not included in the Register; or

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

                   (eb)  particular medical devices were suspended from the Register; or

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

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

                     (h)  there was no declaration under section 7 which applied to particular therapeutic 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

                    (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.

             (5)  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.