Document ID: chunk:federal_register_of_legislation:F2020C00811:reg:3
Version: federal_register_of_legislation:F2020C00811
Segment Type: reg
Provision Reference: reg 3
Character Range: 6996–9108

3                      A variation of either or both of the following particulars:                                                                                                                                                                                                                                                                        a registration of a chemical product, other than
                           (a)      the name of a manufacturer of a  chemical product outside Australia;                                                                                                                                                                                                                                                      (a)    a chemical product that is prescribed under subregulation 59(1); or
                                                                                                                                                                                                                                                                                                                                                              (b)    an immunobiological product
                           (b)      the address of each site outside Australia at which the chemical product is manufactured by a manufacturer that conducts primary steps of manufacture in relation to the chemical product, but only if, under the varied particulars:

                              (i)       at the time of the holder's application, the site of manufacture is entered in the Register as a site for another chemical product of the holder, and the manufacturer conducts the same steps of manufacture in relation to the other chemical product; and

                              (ii)     the holder of the registration of the chemical product possesses evidence that each step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code