Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - REG 46

46. (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 the goods are
        included, the registration or listing number of the goods, the date on
        which the goods were listed or registered and the class in which the
        goods are included;

   (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 drugs, therapeutic devices that contain drugs or
        therapeutic devices that are presented in a pharmaceutical form:

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

        (ii)   the entry relating to the goods in the Poisons Schedule; 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 therapeutic devices, a description of the devices,
        including the name and code (if any) by which the devices are
        classified.