Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 16R

  (1)   On receiving an application under subregulation   16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, 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 medicine:

  (a)   the medicine is:

  (i)   a new prescription medicine; or

  (ii)   a new indications medicine;

  (b)   an indication of the medicine (the priority indication ) 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 medicine 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 medicine provides a major therapeutic advance.

Note:   Paragraph   16(1)(e) of the Act provides that, for the purposes of Part   3 - 2 of the Act, therapeutic goods (other than medicine of the kind to which subsection   16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.

Information to be specified in determination

  (3)   The determination must specify:

  (a)   the person who, as a result of section   25AAA of the Act, is the priority applicant; and

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

  (c)   the priority indication of the medicine.

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.