Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16L

Extension of designation

  (1)   If a designation under regulation   16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.

  (2)   An application under subregulation   (1) to extend a designation must:

  (a)   be in a form approved, in writing, by the Secretary; and

  (b)   be made at least 28 days before the designation would cease to be in force.

  (3)   On receiving an application under subregulation   (1) to extend a designation, the Secretary must decide either:

  (a)   to extend the designation; or

  (b)   to refuse to extend the designation.

  (4)   The Secretary may extend the designation if:

  (a)   the Secretary has not previously extended the designation; and

  (b)   the Secretary is satisfied that:

  (i)   if the medicine is not a new dosage form medicine--the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or

  (ii)   if the medicine is a new dosage form medicine--the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and

  (c)   the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section   23 of the Act before the end of the extended designation.

Notification of decision

  (5)   As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.

  (6)   If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.


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