I want to register a product and apply for the concurrent approval of a new source of active

Guidance for submitting applications seeking joint product registration and active approval

Applicants can seek approval of a new source of an existing active constituent in conjunction with a product registration under application Items 5, 6 and 10.

Item 7 applications are ineligible as that Item does not contain a chemistry assessment module. Applications for approval of a new source of active constituent in conjunction with registration of a product that is closely similar to a registered reference product (usually an Item 7 application) can be made via Item 10.

The following table outlines under which Item certain applications should be lodged.

Application typeIf:Then:

Type 1:

The product registration application would ordinarily be seeking consideration under Item 5?and?also seeks approval of a new source of active constituent.

The (existing) active constituent complies with a monograph or compendial standard in the British Pharmacopoeia, British Pharmacopoeia (Veterinary), European Pharmacopoeia or United States Pharmacopeia.

Yes—remains as Item 5.

No—requires lodgement via an Item 10?(refer Type 1, Item 10 below).

Type 2:

The product registration application would ordinarily be seeking consideration under Item 6 and?also seeks approval of a new source of active constituent.

The (existing) active constituent complies with a monograph or compendial standard in the British Pharmacopoeia, British Pharmacopoeia (Veterinary), European Pharmacopoeia or United States Pharmacopeia.

Yes—remains as Item 6.

No—requires lodgement via an Item 10?(refer Type 2, Item 10 below).

Type 3:?

The product registration application would ordinarily be seeking consideration under Item 7?and also seeks approval of a new source of active constituent.

Requires lodgement via an Item 10?(refer Type 3, Item 10 below).

Type 4:?

The product registration application would ordinarily be seeking consideration under Item 10?and also seeks approval of a new source of active constituent.

Requires lodgement via an Item 10?(refer Type 4, Item 10 below).

Assessment fees and timeframes

Please note: the fees referenced in this tailored guidance take effect from 1 July 2020. For a list of fees and charges up to 30 June 2020, please view the timeframe and fees section on our website.

Item 5:?Fee = $7566.?Assessment period = 8 months.

Item 6: Fee = $6406. Assessment period = 8 months.

Item 10: Fee and assessment period is determined by the relevant modules. These modules can vary, depending upon whether or not the product would ordinarily be seeking consideration under Item 5, 6, 7, or 10 as follows.

Type 1—Item 10

For those applications that would ordinarily have been lodged under Item 5, although the active constituent does NOT comply with a monograph or compendial standard, the following modules would apply:

Module

Timeframe

Fee

1: Preliminary assessment

1 month

$902

2.3: Chemistry (product)

6 months

$1 954

2.3: Chemistry (active)

6 months

$1 954

8.3: Efficacy/target safety

3 months

$1 160

12: Data protection

N/A

$460

11.2: Finalisation

2 months

$3 090

Total

8 months

$9 520

Although this application type should be lodged as an Item 10 application, please refer to the tailored guidance for Item 5 applications for more information on the legislation, module descriptors, and application requirements as these will also be relevant for this application type.

Type 2—Item 10

For those applications that would ordinarily have been lodged under Item 6, although the active constituent does NOT comply with a monograph or compendial standard, the following modules would apply:

Module

Timeframe

Fee

1: Preliminary assessment

1 month

$902

2.3: Chemistry (product)

6 months

$1 954

2.3: Chemistry (active)

6 months

$1 954

12: Data protection

N/A

$460

11.2: Finalisation

2 months

$3 090

Total

8 months

$8 360

Although this application type should be lodged as an Item 10 application, please refer to the tailored guidance for Item 6 applications for more information on the legislation, module descriptors, and application requirements as these will also be relevant for this application type.

Type 3—Item 10

For those applications that would ordinarily have been lodged under Item 7, the following modules would apply:

Module

Timeframe

Fee

1: Preliminary assessment

1 month

$902

2.3: Chemistry (active)

6 months

$1 954

12: Data protection

N/A

$460

11.2: Finalisation

2 months

$3 090

Total

8 months

$6 406

Although this application type should be lodged as an Item 10 application, please refer to the tailored guidance for Item 7 applications for more information on the legislation, module descriptors, and application requirements as these will also be relevant for this application type.

Type 4—Item 10

For those applications that would ordinarily have been lodged under Item 10, the following modules may apply for the product and active. Further information on modules types and levels of assessment is available in the Module Descriptors.

Module

1: Preliminary assessment

Required

2.3: Chemistry (active)

2.3: Chemistry (product)

3: Toxicology (active)

For technical assessment Modules 3 to 10, whether an assessment is required will depend on the specific situation. Applicants should refer to the tailored guidance pathway 'I want to register a new product with an existing active or new combination of approved actives' for more information on the relevant modules and application requirements.

3: Toxicology (product)

4: Toxicology (requiring poison schedule classification) (product)

5: Residues (product)

6: Work health and safety (product)

7: Environment (product)

8: Efficacy and safety (product)

9: Non-food trade (product)

10: Special data (active)

10: Special data (product)

12: Data protection

Required

11: Finalisation: 11.1 (≥3 Modules) or 11.2 (<3 Modules)

Required

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.

Note 1: For each of the above scenarios, it assumes the proposed product only contains one active constituent seeking approval. For applications where approval is sought for more than one active constituent, a chemistry Module 2.3 and fee must be applied for each additional active constituent. Irrespective of how many chemistry modules are required to account for both product and active constituent assessments, the chemistry module is only counted once for the purposes of the finalisation module.

Note 2: While assessment periods are determined based on the required modules, please note if the APVMA makes a request for additional information under section 159 of the Agvet Code, the assessment period will be extended.

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Agricultural products

You will be redirected to online services to log in. You will be able to select the appropriate modules once you have generated the decision ID.

Veterinary products

You will be redirected to online services to log in. You will be able to select the appropriate modules once you have generated the decision ID.

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