Therapeutic Goods Regulations 1990

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

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:

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

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

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

the class in which the goods are included in the Register;

the name of the goods and the name and address of the sponsor of the goods;

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

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

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:

the quantity of goods to be in the primary pack; and

the entry relating to the goods in the Poisons Standard; and

the indications for the goods; and

the dosage form of the goods and their physical appearance; and

the names and quantities of therapeutically active substances in the goods; and

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

the routes of administration of the goods; and

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

if the goods are a kind of medical device:

the intended purpose of the device; and

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

the medical device classification applying to the device;

whether the goods are a designated orphan drug;

if the goods are a biological—which class.

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.