Commonwealth Numbered Acts

HEALTH AND COMMUNITY SERVICES LEGISLATION AMENDMENT ACT (No. 2) 1993 No. 76 of 1993 - SECT 37

37. Section 25 of the Principal Act is amended:

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

"(2B) 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.

"(2C) 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.

"(2D) 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 (2D) the following subsections:

"(2E) 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.

"(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).