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Health Acts Amendment Act 1981 No. 118 of 1981 - SECT 89
89. After Part III of the Principal Act the following Parts are inserted:
''PART IIIA-BIOLOGICAL PRODUCTS
Interpretation
''23A. (1) In this Part, unless the contrary intention appears-
'biological product' means goods for therapeutic use that are, are produced
from, or the production of which involves the use of, organisms or the tissue
or body fluids of organisms, and includes vaccines and toxoids, but does not
include antibiotics or products derived from plants, other than antibiotics or
such products that are used as antigens or haptens;
'manufacturing corporation' means a prescribed corporation that produces, or
proposes to produce, biological products;
'procedures', in relation to the production of a biological product, includes
testing procedures in relation to the production of the product, whether
carried out during, or after the completion of, the production of the product.
''(2) Nothing in this Part shall be taken as limiting the operation of the
other Parts of this Act in relation to biological products. Additional
operation of Part
''23B. Without prejudice to its effect apart from this section, this Part also
has, by force of this section, the effect it would have if-
(a) any references in sections 23D, 23E, 23F and 23G to the production in
Australia of biological products were, by express provision, confined
to-
(i) the production in Australia of those products for supply-
(A) in the course of trade or commerce among the States,
between a State and a Territory or between two
Territories;
(B) under a law of the Commonwealth relating to the provision
of pharmaceutical benefits;
(C) to the Commonwealth or the Northern Territory or to an
authority of the Commonwealth or of a Territory; or
(D) in an internal Territory; or
(ii) the production of those products in an internal Territory;
(b) any references in those sections to the supply in Australia of
biological products were, by express provision, confined to-
(i) the supply in Australia of biological products-
(A) in the course of trade or commerce among the States,
between a State and a Territory or between two
Territories;
(B) under a law of the Commonwealth relating to the provision
of pharmaceutical benefits; or
(C) to the Commonwealth or the Northern Territory or to an
authority of the Commonwealth or of an internal
Territory; or
(ii) the supply of biological products in an internal Territory; and
(c) any references in those sections to a manufacturing corporation
included a reference to a person, not being a prescribed corporation,
who produces, or proposes to produce, biological products. Object of
Part
''23C. The object of this Part is to ensure, so far as the Constitution
permits, the safety, quality and efficacy of biological products that are
supplied in Australia or produced in Australia. General information to be
provided on manufacturing and testing procedures
''23D. (1) The Director-General may, by notice in writing served on a
manufacturing corporation, require the manufacturing corporation to furnish to
him such information in writing as is required by the notice with respect to
the procedures carried out, or to be carried out, by the manufacturing
corporation in the production in Australia of a biological product specified
in the notice.
''(2) Where the Director-General has, by notice under sub-section (1),
required a manufacturing corporation to furnish to him information in writing
with respect to the production in Australia of a biological product, the
manufacturing corporation shall not produce in Australia that biological
product, or supply in Australia that biological product to another person,
unless-
(a) the manufacturing corporation has furnished the information required;
or
(b) the Director-General has, upon application in writing made to him by
the manufacturing corporation or on his own initiative, authorized the
manufacturing corporation, by notice in writing served on the
manufacturing corporation, to produce that biological product or to
supply that biological product to other persons and that notice is in
force at the time when the manufacturing corporation produces that
biological product or supplies that biological product to that other
person, as the case requires.
''(3) The Director-General may, where he considers it appropriate to do so,
include in a notice under sub-section (1) a direction that the manufacturing
corporation shall comply with sub-section (4) in relation to a biological
product to which the notice relates.
''(4) Where-
(a) a manufacturing corporation has been served with a notice under
sub-section (1) that contained a direction referred to in sub-section
(3) in relation to a biological product; and
(b) the manufacturing corporation has, in accordance with the requirement
in that notice, furnished information with respect to the procedures
carried out, or to be carried out, by the manufacturing corporation in
the production in Australia of that biological product, the
manufacturing corporation shall not-
(c) produce in Australia that biological product in accordance with
procedures that differ from the procedures specified in the
information furnished; or
(d) supply in Australia to another person that biological product if that
biological product has been produced in accordance with procedures
that differ from the procedures specified in the information
furnished, unless the manufacturing corporation has, not less than 28
days before commencing to produce that biological product, furnished
to the Director-General information, in writing, with respect to the
procedures to be carried out by the manufacturing corporation in the
production of that biological product.
''(5) The Director-General may, by notice in writing served on a manufacturing
corporation that has been served with a notice under paragraph (2) (b), revoke
that last-mentioned notice. Information to be provided in relation to
particular batches
''23E. (1) The Director-General may, by notice in writing served on a
manufacturing corporation, require the manufacturing corporation to furnish to
him such information in writing, records or samples as are required by the
notice with respect to the procedures carried out, or to be carried out, by
the manufacturing corporation in the production in Australia of a specified
batch or other quantity of a specified biological product.
''(2) Where, in accordance with a requirement in a notice under sub-section
(1), a manufacturing corporation has furnished to the Director-General
information in writing, records or samples with respect to the procedures
carried out in the production in Australia of a specified batch or other
quantity of a biological product, the Director-General may, by notice in
writing served on the manufacturing corporation, direct the manufacturing
corporation not to supply in Australia to any person any part of that batch or
other quantity of the biological product.
''(3) Where, in accordance with a requirement in a notice under sub-section
(1), a manufacturing corporation has furnished to the Director-General
information in writing, records or samples with respect to the procedures to
be carried out in the production in Australia of a specified batch or other
quantity of a biological product, the Director-General may-
(a) by notice in writing served on the manufacturing corporation, direct
the manufacturing corporation not to take any step or further step in
the production in Australia of any part of that batch or other
quantity of the biological product; or
(b) by notice in writing served on the manufacturing corporation, direct
the manufacturing corporation not to supply in Australia to any person
any part of that batch or other quantity of the biological product.
''(4) Where a manufacturing corporation has, by notice under sub-section (1),
been required to furnish information in writing, records or samples with
respect to the procedures carried out in the production in Australia of a
specified batch or other quantity of a biological product, the manufacturing
corporation shall not supply in Australia to another person any part of that
batch or other quantity of the biological product unless the manufacturing
corporation has furnished the information, records or samples required.
''(5) Where, in accordance with a requirement in a notice under sub-section
(1), a manufacturing corporation has furnished to the Director-General
information in writing, records or samples with respect to the procedures
carried out in the production in Australia of a specified batch or other
quantity of a biological product, the manufacturing corporation shall not-
(a) in a case where the Director-General has served notice on the
manufacturing corporation under sub-section (2) in relation to that
batch or other quantity of the biological product-supply in Australia
to another person any part of that batch or other quantity of the
biological product unless the Director-General has, upon application
in writing made to him by the manufacturing corporation or on his own
initiative, authorized the manufacturing corporation, by notice in
writing served on the manufacturing corporation, to supply to other
persons that batch or other quantity of the biological product and
that notice is in force at the time when the manufacturing corporation
supplies that part of that batch or other quantity of the biological
product to that other person; or
(b) in any other case-supply in Australia to another person any part of
that batch or other quantity of the biological product unless a period
of 28 days has elapsed since the manufacturing corporation furnished
the information, records or samples.
''(6) Where a manufacturing corporation has, by notice, under sub-section (1),
been required to furnish information in writing, records or samples with
respect to the procedures to be carried out in the production in Australia of
a specified batch or other quantity of a biological product, the manufacturing
corporation shall not take any step or further step in the production in
Australia of any part of that batch or other quantity of the biological
product unless the manufacturing corporation has furnished the information,
records or samples required.
''(7) Where, in accordance with a requirement in a notice under sub-section
(1), a manufacturing corporation has furnished to the Director-General
information in writing, records or samples with respect to the procedures to
be carried out in the production in Australia of a specified batch or other
quantity of a biological product, the manufacturing corporation shall not-
(a) in a case where the Director-General has served notice on the
manufacturing corporation under paragraph (3) (a) in relation to that
batch or other quantity of the biological product-take any step or
further step in the production in Australia of any part of that batch
or other quantity of the biological product unless the
Director-General has, upon application in writing made to him by the
manufacturing corporation or on his own initiative, authorized the
manufacturing corporation, by notice in writing served on the
manufacturing corporation, to produce that batch or other quantity of
the biological product and that notice is in force at the time when
the manufacturing corporation takes that step or further step in the
production of that part of that batch or other quantity of the
biological product;
(b) in a case where the Director-General has served notice on the
manufacturing corporation under paragraph (3) (b) in relation to that
batch or other quantity of the biological product-supply in Australia
to another person any part of that batch or other quantity of the
biological product unless the Director-General has, upon application
in writing made to him by the manufacturing corporation, or on his own
initiative, authorized the manufacturing corporation, by notice in
writing served on the manufacturing corporation, to supply to other
persons that batch or other quantity of the biological product and
that notice is in force at the time when the manufacturing corporation
supplies that part of that batch or other quantity of the biological
product to that other person; or
(c) in any other case-take any step or further step in the production in
Australia of any part of that batch or other quantity of the
biological product unless a period of 28 days has elapsed since the
manufacturing corporation furnished the information, records or
samples.
''(8) Where a manufacturing corporation has been served with a notice under
sub-section (2) or paragraph (3) (a) or (b), the Director-General may, upon
application in writing made to him by the manufacturing corporation or on his
own initiative, revoke that notice by notice in writing served on the
manufacturing corporation.
''(9) The Director-General may, by notice in writing served on a manufacturing
corporation that has been served with a notice under paragraph (5) (a), (7)
(a) or (7) (b), revoke that last-mentioned notice. Prescribed methods of
manufacturing and testing
''23F. (1) The Minister may, by order in writing, determine the procedures to
be carried out in the production in Australia of a biological product
specified in the order.
''(2) Where, in pursuance of sub-section (1), procedures are determined in
relation to the production in Australia of a biological product-
(a) a manufacturing corporation shall not supply in Australia that
biological product to another person unless that biological product
has been produced in accordance with those procedures; and
(b) a person shall not import, without the authority in writing of the
Director-General, that biological product into Australia unless that
biological product has been produced in accordance with those
procedures.
''(3) Without limiting the generality of sub-section (1), the Minister may
determine procedures under that sub-section by reference to a monograph in the
British Pharmacopoeia or in a publication referred to in paragraph 16A (1)
(b), with or without modification of that monograph.
''(4) Sections 16, 17 and 18 apply to an order made under sub-section (1) of
this section as if it were an order made under Part II. Manufacturers to keep
records
''23G. (1) The Director-General may, by notice in writing served on a
manufacturing corporation, require the manufacturing corporation to keep such
records as are specified in the notice with respect to the procedures carried
out by the manufacturing corporation in relation to the production in
Australia of each batch or other quantity of a biological product specified in
the notice that the manufacturing corporation produces after the date on which
the notice is served.
''(2) The Director-General may, by notice in writing served on a manufacturing
corporation required to keep records in pursuance of a notice under
sub-section (1), require that manufacturing corporation to furnish to the
Director-General such of those records, or copies of such of those records, as
are specified in the notice under this sub-section.
''(3) The Director-General may, by notice in writing served on a manufacturing
corporation that has been served with a notice under sub-section (1), amend or
revoke that notice.
''(4) A manufacturing corporation shall not fail to comply with a notice
served on the manufacturing corporation under this section that is in force.
Penalty: $5,000.
''PART IIIB-NATIONAL REGISTER OF THERAPEUTIC GOODS
Interpretation
''23H. A reference in this Part to goods for therapeutic use does not include
a reference to goods that are not for human use. Additional operation of Part
''23J. Without prejudice to its effect apart from this section, this Part also
has, by force of this sub-section, the effect it would have if-
(a) any reference in section 23M to the production in Australia of goods
for therapeutic use were, by express provision, confined to-
(i) the production in Australia of such goods for supply-
(A) in the course of trade or commerce among the States,
between a State and a Territory or between two
Territories;
(B) under a law of the Commonwealth relating to the provision
of pharmaceutical benefits;
(C) to the Commonwealth or the Northern Territory or to an
authority of the Commonwealth or of a Territory; or
(D) in an internal Territory; or
(ii) the production of such goods in an internal Territory; and
(b) any reference in that section to the supply in Australia of goods for
therapeutic use were, by express provision, confined to-
(i) the supply in Australia of such goods-
(A) in the course of trade or commerce among the States,
between a State and a Territory or between two
Territories;
(B) under a law of the Commonwealth relating to the provision
of pharmaceutical benefits; or
(C) to the Commonwealth or to the Northern Territory or to an
authority of the Commonwealth or of an internal
Territory; or
(ii) the supply of such goods in an internal Territory;
(c) any reference in that section to a prescribed corporation included a
reference to a person not being a prescribed corporation. Object of
Part
''23K. The object of this Part is to provide for the establishment and
maintenance, so far as the Constitution permits, of a record of such
information relating to goods for therapeutic use that are supplied in
Australia, or produced in Australia, as is necessary to be kept in the
interest of the public health of the people of the Commonwealth. National
Register of Therapeutic Goods
''23L. (1) There shall be a register, to be known as the National Register of
Therapeutic Goods, in which shall be entered such information in relation to
goods for therapeutic use that are supplied in Australia or produced in
Australia as the Director-General determines.
''(2) The National Register of Therapeutic Goods shall be maintained in
accordance with directions given by the Director-General and may, if he so
directs, be maintained in a computer. Director-General may obtain information
''23M. (1) For the purpose of compiling and maintaining the National Register
of Therapeutic Goods, the Director-General may, by notice in writing served on
a prescribed corporation that supplies in Australia, or produces in Australia,
goods for therapeutic use, require that prescribed corporation to furnish, in
writing, to the Director-General, or another person specified in the notice,
within such period as is specified in the notice, such information in respect
of goods for therapeutic use that the prescribed corporation has supplied in
Australia, or has produced in Australia, as is required by the notice.
''(2) A notice served on a prescribed corporation under sub-section (1) shall
not require the prescribed corporation to furnish information in respect of
goods for therapeutic use that consist of a substance unless-
(a) the goods are declared, or are included in a class of goods that are
declared, by the regulations to be goods to which this section
applies; and
(b) the information relates to prescribed matters.
''(3) A notice served on a prescribed corporation under sub-section (1) may
relate to-
(a) specified goods that have been supplied in Australia or produced in
Australia by the prescribed corporation;
(b) all goods of a specified description that the prescribed corporation
has, within a period specified in the notice, supplied in Australia or
produced in Australia; or
(c) all goods for therapeutic use that the prescribed corporation has,
within a period specified in the notice, supplied in Australia or
produced in Australia.
''(4) The Director-General may, where he considers it appropriate to do so,
include in a notice under sub-section (1) a direction that a prescribed
corporation shall, not less than 14 days before supplying in Australia any
goods for therapeutic use to which the notice relates and in respect of any
matter relating to which the information furnished in accordance with the
notice is not correct, furnish to the Director-General in writing correct
information in relation to those matters.
''(5) Where a notice served on a prescribed corporation under sub-section (1)
is in the form referred to in paragraph (3) (b) or (c), the Director-General
may, if he considers it appropriate to do so, include in that notice a
direction that, if at any time the prescribed corporation commences to supply
in Australia, or to produce in Australia, goods of the description to which
the notices relates, being goods that the prescribed corporation has not,
within the period specified in the notice in accordance with paragraph (3) (b)
or (c), as the case may be, so supplied or produced, the prescribed
corporation shall not supply those goods in Australia to another person unless
the prescribed corporation has, not less than 14 days before supplying those
goods, furnished to the Director-General in writing the information required
by the notice in respect of the goods.
''(6) Where-
(a) a prescribed corporation has, in compliance with a notice under this
section, furnished information in relation to goods; and
(b) the corporation ceases to supply in Australia, or to produce in
Australia, such goods, the corporation shall forthwith notify the
Director-General in writing that it has so ceased to supply or to
produce such goods, as the case requires.
''(7) A person shall not fail to comply with a notice served on him under this
section.
Penalty: $200.
''(8) A person shall not, in purported compliance with a notice served on him
under this section, knowingly furnish information that is false or misleading
in a material particular.
Penalty: $2,000.
''(9) A prescribed corporation is not excused from furnishing information in
pursuance of a notice served on it under this section on the ground that the
information might tend to incriminate it, but any information furnished in
pursuance of the notice is not admissible in evidence against it in any
criminal proceedings, other than proceedings under sub-section (8).''.
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