Commonwealth Numbered Acts

HEALTH LEGISLATION AMENDMENT ACT (No. 2) 1986 No. 94 of 1986 - SECT 42

42. After section 23E of the Principal Act the following section is inserted:
Secretary may require samples to be provided automatically

"23EA. (1) The Secretary may, by notice in writing served on a manufacturing
corporation, require the corporation to furnish to the Secretary such samples
as are required by the notice of each batch or other quantity of-

   (a)  a specified biological product;

   (b)  biological products of a specified kind; or

   (c)  all biological products, produced in Australia by the corporation.

"(2) Where, in accordance with a requirement in a notice under sub-section
(1), a corporation has furnished to the Secretary samples of a batch or other
quantity of a biological product, the Secretary may, by notice in writing
served on the corporation, direct the corporation not to supply in Australia
to any person any part of that batch or other quantity of that biological
product.

"(3) Where a corporation has, by notice under sub-section (1), been required
to furnish samples of a batch or other quantity of a biological product, the
corporation shall not supply in Australia to another person any part of that
batch or other quantity of that biological product unless the corporation has
furnished the samples required.

"(4) Where, in accordance with a requirement in a notice under sub-section
(1), a corporation has furnished to the Secretary samples of a batch or other
quantity of a biological product, the corporation shall not-

   (a)  in any case where the Secretary has served notice on the 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 Secretary has, on application in writing made to the Secretary by
        the corporation or on the Secretary's own initiative, authorised the
        corporation, by notice in writing served on the 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 supply
        occurs; 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 corporation furnished the samples.

"(5) Where a corporation has been served with a notice under sub-section (2),
the Secretary may, upon application in writing made to the Secretary by the
corporation or on the Secretary's own initiative, revoke that notice by notice
in writing served on the corporation.".