7Application, savings and transitional provisions

7 Application, savings and transitional provisions

This instrument, as in force immediately before the amendments made by the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025, continues to apply to applications for registration made before 1 October 2025.

Schedule 1—Prescription Medicines

Note: See section 6.

<table cellspacing="0" cellpadding="0" style="width:412.85pt; margin-left:5.35pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:402.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Prescription medicines</span></p></td></tr><tr><td style="width:47.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:343.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td></tr><tr><td style="width:47.75pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:343.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Prescription medicines</span></p></td></tr></thead><tbody><tr><td style="width:47.75pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:343.7pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>new chemical entity medicine</span></p></td></tr><tr><td style="width:47.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:343.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>new biological entity medicine</span></p></td></tr><tr><td style="width:47.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:343.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>new biosimilar medicine</span></p></td></tr><tr><td style="width:47.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:343.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>new combination medicine</span></p></td></tr><tr><td style="width:47.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:343.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>extension of indications medicine</span></p></td></tr><tr><td style="width:47.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:343.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>major variation medicine</span></p></td></tr><tr><td style="width:47.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:343.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>new generic medicine</span></p></td></tr></tbody></table>