Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A medicine, 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 medicine'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.