The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
This appendix applies to Part 1, Section 1.3, Product table.
Variations
Where applicants are seeking a variation to an existing registration, an AUST R number must be included.
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| 123456 | Amoxycillin (as trihydrate) | Cillin-X | 250 mg | capsule | blister pack |
| 123457 | Amoxycillin (as trihydrate) | Cillin-X | 500 mg | capsule | blister pack |
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Amoxycillin (as trihydrate) | Cillin-X | 250 mg and 500 mg | capsule | blister packs |
Where an application seeks variations to existing registrations and new registrations, the AUST R number must be included for the existing registrations. An empty AUST R field indicates a new registration.
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| 123456 | Amoxycillin (as trihydrate) | Cillin-X | 250 mg | capsule | blister pack |
| Amoxycillin (as trihydrate) | Cillin-X | 1 mg | powder for injection | vial |
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Amoxycillin (as trihydrate) | Cillin-X | 250 mg | capsule | blister pack | |
| Amoxycillin (as trihydrate) | Cillin-X | 1 mg | powder for injection | vial |
Multiple products
For new registrations, some products may be combined into a single line where all details but one are common.
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Amoxycillin (as trihydrate) | [tradename A] | 250 mg | capsule | blister packs and bottles | |
| Amoxycillin (as trihydrate) | [tradename B] | 500 mg | capsule | blister pack | |
| Amoxycillin (as trihydrate) | [tradename C] | 500 mg | capsule | blister pack |
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Amoxycillin (as trihydrate) | [tradename A]/ [tradename B]/ [tradename C] | 250 mg/ 500 mg | capsule | blister packs and bottles |
Multi-ingredient products
Where there are multiple active ingredients, the active ingredient amounts must be recorded in the same order in which they are listed in the table.
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Amoxycillin (as trihydrate)/ Clavulanic Acid | [tradename A] | 250 mg/ 125 mg | capsule | blister packs and bottles | |
| Amoxycillin (as trihydrate)/ Clavulanic Acid | [tradename B] | 500 mg/ 125mg | capsule | blister pack |
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Amoxycillin (as trihydrate)/ Clavulanic Acid | [tradename A] | 125 mg/ 250 mg | capsule | blister packs and bottles | |
| Amoxycillin (as trihydrate)/ Clavulanic Acid | [tradename B] | 500 mg/ 125 mg | capsule | blister pack |
Multi-component products
Multi-component products can be recorded in a number of ways. Each method requires that the components are clearly identified in the table.
For example, a mixture of single and multiple component products containing the same active ingredients can be recorded as follows:
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Somatropin | [tradename] | 10mg | powder for injection | vial | |
| Somatropin | [tradename] | 1-10 mg 2-2 mL | 1 - powder for injection 2 - diluent | 1 - vial 2 - syringe | |
| Somatropin | [tradename] | 1 - 20 mg 2 - 4 mL | 1 - powder for injection 2 - diluent | 1 - vial 2 - ampoule |
For a multi-active, multi-component product, details can be recorded as follows:
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Ethinyloestradiol/ levonorgestrel | [tradename] - component 1 | 0.03 mg/0.125 mg | tablet | blister pack | |
| Ethinyloestradiol/ levonorgestrel | [tradename] - component 2 | 0.03 mg/0.05 mg | tablet | blister pack | |
| Ethinyloestradiol/ levonorgestrel | [tradename] - component 3 | 0.04 mg/0.075 mg | tablet | blister pack | |
| placebo | [tradename] - component 4 | N/A | tablet | blister pack |
Or, where there is more than one product proposed:
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Ethinyloestradiol/ levonorgestrel | [tradename] (28 day) | 1 - 0.03 mg/0.125 mg 2 - 0.03 mg/0.05 mg 3 - 0.04 mg/0.075 mg 4 – 0/0 (placebo) | 1 - tablet 2 - tablet 3 - tablet 4 - tablet | blister pack | |
| Ethinyloestradiol/ levonorgestrel | [tradename] (21 day) | 1 - 0.03 mg/0.125 mg 2 - 0.03 mg/0.05 mg 3 - 0.04 mg/0.075 mg | 1 - tablet 2 - tablet 3 - tablet | blister pack |
For a multi-component product with different actives in different components:
| AUST R | Active | Trade name | Strength | Dosage form | Pack |
|---|---|---|---|---|---|
| Risedronate sodium/ calcium carbonate | [tradename] | 1 – 35 mg risedronate sodium 2 – 2500 mg calcium carbonate | 1 - tablet 2 - tablet | blister pack |