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Information for applicants completing a pre-submission planning form

Applicable to pre-submission planning forms lodged under the prescription medicines registration process from 1 May 2014

1 May 2014

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Appendix A - Completing the product details table

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.

Acceptable
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
Not Acceptable
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.

Acceptable
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
Not Acceptable
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.

Acceptable
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
Not Acceptable
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.

Acceptable
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
Not Acceptable (ingredients and strengths in different order)
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

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