Document ID: chunk:federal_register_of_legislation:C2004A04631:body:0:p11
Version: federal_register_of_legislation:C2004A04631
Segment Type: other
Provision Reference: 
Character Range: 26055–28909

of a Convention country and relating to:

        (a) the general standards of manufacturing practice of a particular manufacturer; or

        (b) the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.

    "(2F) For the purposes of subsection (2E), a Convention country is a country that is a party to the Mutual Recognition Convention.

    "(2G) Information referred to in subsection (2E) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 4 of this Act.";

    (c) by omitting paragraph (3)(b) and substituting the following paragraph:

         "(b) if the decision is to register the goods—include the goods in the Register and give the applicant a certificate of registration.";

  (d) by omitting subsection (4).

Listing of therapeutic goods

  38. Section 26 of the Principal Act is amended:

  (a) by inserting after subsection (2) the following subsections:

    "(2A) If therapeutic goods are exempt from the operation of Part 4 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.

    "(2B) If a person is exempt from the operation of Part 4 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 4 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.

      "(2C) If:

     (a) therapeutic goods were made outside Australia; and

        (b) had the goods been made in Australia, they would have been exempt from the operation of Part 4;

    subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.";

  (b) by inserting after subsection (2C) the following subsections:

    "(2D) A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:

        (a) the general standards of manufacturing practice of a particular manufacturer; or

        (b) the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.

     "(2E) For the purposes of subsection (2D), a Convention country is a country that is a party to the Mutual Recognition Convention.

     "(2F) Information referred to in subsection (2D) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 4 of this Act.";

     (c) by omitting from subsection (3) "include the goods in the