Commonwealth Consolidated Regulations

[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

THERAPEUTIC GOODS REGULATIONS 1990 - REG 16H

Application to designate medicine as orphan drug

  (1)   The sponsor of a medicine may apply to the Secretary to designate, in writing, the medicine as an orphan drug.

  (2)   An application under subregulation   (1) must be in a form approved, in writing, by the Secretary.


AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback