Commonwealth Numbered Regulations

THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1997 No. 399 - REG 4

4.1 After Part 3A, insert:

"PART 3B-ORPHAN DRUGS Orphan drug

"16H. (1) A drug, vaccine or in vivo diagnostic agent is an orphan drug if it
complies with this regulation.

"(2) It:

   (a)  must be intended to treat, prevent or diagnose a rare disease; or

   (b)  must not be commercially viable to supply to treat, prevent or
        diagnose another disease or condition.

"(3) It is not an orphan drug if any of the following persons or bodies has
refused to approve it for use for the disease for a reason related to the
drug's safety:

   (a)  the Secretary;

   (b)  the Food and Drug Administration of the United States of America;

   (c)  the Medicines Control Agency of the United Kingdom;

   (d)  the Bureau of Pharmaceutical Assessment of Canada;

   (e)  the Medical Products Agency of Sweden;

   (f)  the Medicines Evaluation Board of the Netherlands;

   (g)  the European Agency for the Evaluation of Medicinal Products.

"(4) It is not an orphan drug if it has been registered for use for the
disease or condition before 1 January 1998.

"(5) However, it may be registered before 1 January 1998 for another use or
indication. Application for orphan drug designation

"16I. (1) The sponsor of an orphan drug may apply to the Secretary for the
drug to be designated as an orphan drug.

"(2) The application must be made using an application form approved by the
Secretary.

"(3) The application must show why the drug is an orphan drug.

"(4) For a vaccine or in vivo diagnostic agent, the application must also
state that the vaccine or agent will be administered in Australia to not more
than 2,000 people in each year after it is registered for use for the disease
or condition. [NOTE: There is no fee for making the application: see
subregulation 45 (12).] Orphan drug designation

"16J. (1) The Secretary must consider the application.

"(2) The Secretary must designate the drug, in writing, as an orphan drug if
the Secretary is satisfied that the statements made in the application are
correct.

"(3) The Secretary must refuse to designate the drug as an orphan drug if the
Secretary is not satisfied that all of the statements made in the application
are correct.

"(4) The Secretary must tell the applicant in writing, as soon as practicable
after making the decision, whether the drug has been designated. [NOTE: There
is no fee for making the Secretary's decision: see subregulation 45 (12).]

"(5) If the Secretary designates the drug, the Secretary must publish a notice
in the Gazette, as soon as practicable after making the decision, giving the
following information:

   (a)  the sponsor's name;

   (b)  the drug's dose form and indication;

   (c)  a statement that the drug is a designated orphan drug.