Commonwealth Consolidated Regulations

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Release of information

             (1)  In this regulation, therapeutic goods information has the same meaning as in section 61 of the Act.

             (2)  For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:

                     (a)  whether the goods are included in the Register and, if so:

                              (i)  the registration number, listing number, biological number or device number of the goods; and

                             (ii)  the date when the goods were registered, listed or included in the Register; and

                            (iii)  the class in which the goods are included in the Register;

                     (b)  the name of the goods and the name and address of the sponsor of the goods;

                     (c)  if any ingredient in, or component of, the goods is derived from an animal, the type of the animal;

                     (d)  if the goods are supplied in a sterile state, the type of sterilisation used;

                     (e)  if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:

                              (i)  the quantity of goods to be in the primary pack; and

                             (ii)  the entry relating to the goods in the Poisons Standard; and

                            (iii)  the indications for the goods; and

                            (iv)  the dosage form of the goods and their physical appearance; and

                             (v)  the names and quantities of therapeutically active substances in the goods; and

                            (vi)  the presence or absence of any specific excipient in the goods; and

                           (vii)  the routes of administration of the goods; and

                          (viii)  the type of container in which the goods are to be packed; and

                      (f)  if the goods are a kind of medical device:

                              (i)  the intended purpose of the device; and

                             (ii)  the device nomenclature system code specified for the device under subsection 41BE(3) of the Act; and

                            (iii)  the medical device classification applying to the device;

                     (g)  whether the goods are a designated orphan drug;

                     (h)  if the goods are a biological--which class.

             (4)  For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.

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