Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16W

Making of biologicals (priority applicant) determination

  (1)   On receiving an application under subregulation   16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:

  (a)   consider the application; and

  (b)   decide either:

  (i)   to make the determination; or

  (ii)   to refuse to make the determination.

Criteria

  (2)   The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:

  (a)   the biological is separate and distinct from biologicals included in the Register;

  (b)   either:

  (i)   for a Class 2 biological--an intended clinical use (the priority indication ) of the biological is the treatment, prevention or diagnosis of a life - threating or seriously debilitating condition; or

  (ii)   for a Class 3 or Class 4 biological--a therapeutic indication (the priority indication ) of the biological is the treatment, prevention or diagnosis of a life - threatening or seriously debilitating condition;

  (c)   either:

  (i)   no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or

  (ii)   if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)--there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;

  (d)   there is substantial evidence demonstrating that the biological provides a major therapeutic advance.

Note:   For paragraph   (a), see section   32AB of the Act and regulation   11A for when a biological is separate and distinct from other biologicals.

Information to be specified in the determination

  (3)   The determination must specify:

  (a)   the person who, as a result of section   32DEA of the Act, is the priority applicant; and

  (b)   each active ingredient of the biological to which the determination relates; and

  (c)   the priority indication of the biological.

Notification of decision

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

  (5)   If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.


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