Document ID: chunk:federal_register_of_legislation:F2023C01075:body:0:p2
Version: federal_register_of_legislation:F2023C01075
Segment Type: other
Provision Reference: 
Character Range: 3003–7093

the Therapeutic Goods Regulations 1990.

         intended purpose has the same meaning as given in Therapeutic Goods (Medical Devices) Regulations 2002.

         sample has the same meaning as given in Therapeutic Goods Regulations 1990.
              Note: See also subsection (2).

         trade name has the same meaning as given in Therapeutic Goods Regulations 1990.

         variant has the same meaning as given in Therapeutic Goods (Medical Devices) Regulations 2002.

             Note A number of expressions used in this specification are defined in the Act, including the following:
               (a)     biological number;
               (aa) Commonwealth officer;
               (b)    device number;
               (c)     included in the Register;
               (d)    indications;
               (e)     listing number;
               (f)     manufacture;
               (g)    manufacturer;
               (h)    product information;
               (i)      quality;
               (j)      Register;
               (k)    registration number;
               (l)      sponsor;
               (m)  supply;
               (n)    therapeutic goods; and
               (o)    therapeutic goods information.
 (2) For the avoidance of doubt, a reference in this instrument to a sample includes a sample (or part of a sample) taken, collected or otherwise obtained:
 (a) under the Act; or
 (b) under regulations made under the Act (including the Therapeutic Goods Regulations 1990); or
 (c) by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).
 (3) For the avoidance of doubt, a reference in this instrument to a test includes a test, analysis or examination conducted or otherwise carried out:
 (a) under the Act; or
 (b) under regulations made under the Act (including the Therapeutic Goods Regulations 1990); or
 (c) by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).
     5 Therapeutic goods information
          The kinds of therapeutic goods information mentioned in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.

              Note Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).
Schedule 1 Specified kinds of therapeutic goods information
(section 5)

For each item in column 1 of the following table, the kinds of therapeutic goods information specified in column 2 have the description given in column 3.

  Kinds of therapeutic goods information
  Column 1                                Column 2                                          Column 3
  Item                                    Information                                       Description
  1                                       description of samples of therapeutic goods       in relation to samples of therapeutic goods included on the Register, the following information, as applicable:
                                                                                              (a)    trade name, name and quantity of active ingredients, strength, size, dosage form and model of the therapeutic goods;
                                                                                              (b)    sponsor name;
                                                                                              (c)    manufacturer name;
                                                                                              (d)    registration number, listing number, biological number or device number;
                                                                                              (e)    type, category, class or classification of the therapeutic goods;
                                                                                              (f)     indications for which the therapeutic goods are included