Document ID: chunk:federal_register_of_legislation:F2017L01637:body:0:p2
Version: federal_register_of_legislation:F2017L01637
Segment Type: other
Provision Reference: 
Character Range: 3361–8197

ingredients of the registered goods described in column 3 of item 3
  2                                       particulars of specified therapeutic goods approved under section 19A  the name of specified therapeutic goods approved under section 19A of the Act for which the registered goods described in column 3 of item 3 may be substituted, comprising the trade name, active ingredient name, strength and dosage form
  3                                       particulars of registered goods                                        the name of one or more therapeutic goods included in the Register that are unavailable or in short supply in Australia comprising the trade name, active ingredient name, strength, dosage form and registration number
  4                                       name of person to whom approval is granted under section 19A           the name, contact telephone number and Australian Business Number of the person to whom an approval for importation into Australia, or the supply in Australia, of specified therapeutic goods is granted under section 19A of the Act
  5                                       image of specified therapeutic goods packaging                         one or more photographic or pictorial images of the packaging of the specified therapeutic goods approved under section 19A of the Act, as supplied in one or more foreign countries, displaying in relation to the goods:
                                                                                                                   (a)    the name and address of the person in whose name the goods are registered or approved for general marketing;
                                                                                                                   (b)   the name of one or more active ingredients;
                                                                                                                   (c)    the strength, dosage form and pack size;
                                                                                                                   (d)   the name of the manufacturer;

  Kinds of therapeutic goods information
Column 1                                    Column 2                                                                                                   Column 3
  Item                                      Information                                                                                                Description
                                                                                                                                                       (e)    the name of the distributor, if different from the person in whose name the goods are registered or approved for general marketing;
                                                                                                                                                       (f)     the reference number of the goods registered or approved for general marketing in one or more foreign countries;
                                                                                                                                                       (g)    the storage conditions;
                                                                                                                                                       (h)    the batch number and expiry date; and
                                                                                                                                                       (i)     any other packaging information including additional administration instructions
  6                                       indications of specified therapeutic goods                                                                 the therapeutic uses of the specified therapeutic goods specified in the relevant notice of approval as a condition of that approval under section 19A of the Act
  7                                       expiry date of approval                                                                                     the date on which the approval under paragraph 19A(8)(a) of the Act expires, as specified in the relevant notice of approval
  8                                       information relating to the lapsing of any approval under section 19A for the specified therapeutic goods   the date on which any previous approval under section 19A was granted in relation to the specified therapeutic goods, the period for which it was granted as specified in the relevant notice of approval, the date on which the approval lapsed, and the reason for such lapsing in accordance with paragraph 19A(8)(b) and subsection 19A(9) of the Act
  9                                       medicine shortages information