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Category 14 Application

Variation to a registered chemical product or approved label: Modular assessment

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 14 application as:

Application to vary particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in item 11 to 13.

Category 14 is a modular category. Data requirements, the fee payable and timeframe for assessment depend on which of the modules are required for a particular application. The modules are described in Module levels for modular categories in Volume 3 and also in the guidelines included with the examples later in this chapter.

A Category 14 application may include variations to chemistry and manufacturing details of the product if the new formulation is ‘similar’ to the previous formulation, and/or variations to an approved label.

Variations to product details include details of the formulation (including names, concentrations and standards for each constituent - including the active constituents), release and expiry specifications, immediate container specifications, shelf life, and site of product manufacture.

Data must be provided when a technical assessment is required. The data requirements and level of assessment required depend on the type of product and the type of variation to the product.

1.1.   Application types

The following types of label variations and product variations veterinary applications are eligible for assessment under Category 14:

• variation to the label claims of a product (including new pests, diseases or target animal species)
• variation to the label directions for use of a product involving change to the restraints, contraindications, precautions, side effects statements, and dosage and administration instructions (treatment number, frequency, duration, dose, route of administration)
• variation to label withholding period instructions
• variation to label environmental safety statements including disposal instructions
• variation to the poisons scheduling (signal heading), first aid or user safety directions where these are different from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) or Handbook of First Aid Instructions and Safety Directions (FAISD Handbook)
• minor variation to product details to change formulation or product specifications or variation to active constituents where technical assessment is required
• variation to product details to include a new pack size of different construction or material, or which changes the market sector for the product
• any other variation to the label and/or product details.

Each of these types of application is explained in detail, with examples, in section 4 of this chapter.

1.2.   Major formulation variation is not included in Category 14

Variations to product particulars or conditions of registration do not include major formulation variations to the product, which in effect result in a new product. Major formulation variation is defined in Module levels for modular categories in Volume 3. Major formulation variations may affect target species efficacy and safety, dietary residues, human health and safety and the environment.

Major formulation variations require an application under a category other than Category 14, for registration of a new product with a new name and new product number.

2.   REQUIREMENTS

When making a Category 14 application for variation to the details or particulars of registration of a product and/or label approval, applicants must provide:

• one unbound copy of the combined Application Form and Overview (refer to paragraph 2.1)
• one bound copy of each of the relevant data Parts (refer to paragraph 2.2)

• the product label where applicable (refer to paragraph 2.3)

• the relevant fee (refer to paragraph 2.4)

• the data list where applicable (refer to paragraph 2.7).

2.1.   Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25_F08). A single unbound copy of the combined document must be provided to the APVMA.

The Application Form requires information which is relevant to a Category 14 application.

The Application Overview section of the combined document is in the form of a template. Applicants may use this template, or may submit their own Application Overview although this must conform to the instructions and format provided in Part 1 – Application overview in Volume 3.

Sub-parts 1.1–1.10 of the Application Overview must all be completed.

When there is no information relevant to the variation a statement to this effect must be made under the relevant sub-part heading. For example, if the withholding period or the claim is being varied, sub-parts 1.5 or 1.8 respectively must summarise the data submitted and refer to separate Part 5 or Part 8 data. If in this example the chemistry and manufacturing details remain unchanged, this can be stated in sub-part 1.2 and a separate Part 2 need not be submitted with the application.

2.2.   Data

Category 14 is a modular category, therefore data studies, fee and timeframe are determined by the module levels required for product assessment, which themselves are determined by the type of product and the situations in which the product will be used.

All applications made under Category 14, except for secondary applications, will normally require submission of data for the product, relating to:

Application Overview	Part 1
Chemistry and Manufacture data for the product	Part 2
Toxicology data for the active constituent and product	Part 3
Metabolism and Kinetics	Part 4
Residues and Trade	Part 5a , 5b
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8
Other Trade Aspects	Part 9
Special Data Requirements	Part 10

Note: The Parts relate to Volume 3: Data requirements and guidelines. Further information on data requirements is provided in that volume.

2.3.   Label

Applicants must provide a label with the Application Form and Overview. The APVMA recommends that the label be in draft form so that it can be amended if necessary, however applicants may choose to submit the marketed product label (MPL).

Applicants may provide the draft label as either:

• two copies of the text label (TXL) printed on paper; or
• an e-label on CD. The CD must be attached to the Application Form and Overview and not submitted separately or by email.

The draft label must include all label components ie primary pack, immediate container and leaflet, as relevant.

All parts of the draft label must be in accordance with the latest editions of the:

• Labelling Code
• Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
• Handbook of First Aid Instructions and Safety Directions (FAISD Handbook).

After the APVMA has assessed the draft label and is satisfied that the label is acceptable, the APVMA will ask the applicant to provide an e-label of the MPL for approval. If the MPL is acceptable and all other matters relevant to the application are acceptable, the APVMA will approve the label and grant the application.

Refer to Label Approval Process in Volume 5 for further information.

2.4.   Fee and timeframe

Category 14 is a modular category, therefore the fee payable and timeframe depend on which of the modules are required for assessment of the application.

The fee for a Category 14 application will always include the fees for Module 1 (Screening), plus the relevant Finalisation module (11.1, 11.2, or 11.4), except non-technical secondary applications (see 3.2).

A fee must accompany a Category 14 application. Applicants may provide the complete fee when submitting the application, or may choose to provide $505 (Screening module fee) when submitting the application and provide the remainder of the fee when requested by the APVMA, after the application passes screening.

To calculate the timeframe assigned to an application, the longest assessment period for the specific data modules should be added to the timeframe for the relevant finalisation module.

The fee and timeframe for each application may be calculated by reference to Module levels for modular categories in Volume 3.

2.4.1. Fee for identical variations to multiple products where no technical assessment is required

Paragraph 2.3.1 of Category 12 states that if an applicant wishes to apply for variations to the particulars, conditions, or approved label for a product, where no technical assessment is required, and if:

• the application would normally be made under Category 12; and
• the applicant wishes to make identical changes to multiple products;
  
  - the applicant may apply for the changes under Category 14. Under Category 14, the APVMA will charge a fee constructed from the screening fee and finalisation fee, which is considerably less expensive than if the applicant makes multiple applications under Category 12.

An example is where a registrant applies for approval for a change in the site of manufacture for the registrant’s entire range of products.

The APVMA will charge a fee which is constructed from the screening fee and the finalisation fee. If the application is relevant to more than 5 products, the finalisation fee is ‘broadbanded’ over every 5 products. The table of fees is set out in Table 1.

Table 1: Table of fees for a Category 14 application for an identical change to multiple products

Number of products in the app.	Fee construction	Fee	Number of products in the app.	Fee construction	Fee
2	$505 + 2 × $160	$825	51-55	$505 + 15 × $160	$2,905
3	$505 + 3 × $160	$985	56-60	$505 + 16 × $160	$3,065
4	$505 + 4 × $160	$1,145	61-65	$505 + 17 × $160	$3,225
5	$505 + 5 × $160	$1,305	66-70	$505 + 18 × $160	$3,385
6-10	$505 + 6 × $160	$1,465	71-75	$505 + 19 × $160	$3,545
11-15	$505 + 7 × $160	$1,625	76-80	$505 + 20 × $160	$3,705
16-20	$505 + 8 × $160	$1,785	81-85	$505 + 21 × $160	$3,865
21-25	$505 + 9 × $160	$1,945	86-80	$505 + 22 × $160	$4,025
26-30	$505 + 10 × $160	$2,105	81-85	$505 + 23 × $160	$4,185
31-35	$505 + 11 × $160	$2,265	86-90	$505 + 24 × $160	$4,345
36-40	$505 + 12 × $160	$2,425	91-95	$505 + 25 × $160	$4,505
41-45	$505 + 13 × $160	$2,585	96-100	$505 + 26 × $160	$4,665
46-50	$505 + 14 × $160	$2,745

Requirements

1. If the product label will not change:

The applicant must use the Category 14 application form, and in 1 st and 4 th rows of section 1, write next to ‘Full Name of Product’ and ‘APVMA Product Number’:

‘Multiple products – see attached list’.

The attached list must be a list of all products to which the application applies, in a 3 column format:

APVMA product number

Product name

Pack sizes

Sections 4, 7, 8, 11 and 14 of the Category 14 application form need NOT be filled out. Sections 1.3 – 1.10 of the Application Overview need NOT be filled out.

2. If the product label will change:

The applicant must use the Category 14 application form, and in 1 st and 4 th rows of section 1, write next to ‘Full Name of Product’ and ‘APVMA Product Number’:

‘Multiple products – see attached list’.

The attached list must be a list of all products to which the application applies, in a 3‑column format:

APVMA product number

Product name

Pack sizes

Sections 4, 5, 6, 7, 8, 11, 12 of the Category 14 application form need NOT be filled out.
Sections 1.3 – 1.10 of the Application Overview need NOT be filled out.

2.4.2.  Fee for identical variations to multiple products where a technical assessment is required

The APVMA may consider using the fees in Table 1 for applications where the application requires assessment of a technical module, but the variation will apply to multiple products. In this situation, the fee will be constructed from the relevant row of Table 1, plus one instance of the fee for the relevant technical module.

Applicants should discuss this with the relevant APVMA Team Manager before submitting the application.

2.5.   Use of reference products

Application data requirements are normally addressed by submission of data and/or relevant scientific argument or nomination of a suitable reference product. If an applicant does not provide data or relevant scientific argument to support aspects of their application, the applicant must nominate a suitable registered reference product.

2.6.   Public consultation

Public consultation will be required prior to approval of certain variations, for example if the application is for an extension of use to a new food-producing animal species, or if a new withholding period requires changes to the maximum residue limits (MRL) in the MRL Standard. In such cases the APVMA will conduct a round of public consultation. This is normally by means of publication of a Gazette Notice called a Public Release Summary (PRS) which invites comment on the APVMA’s intention to approve the variation.

If the variation is for an extension of use to a new food-producing animal species, or if residues in animal commodities require changes to MRLs in the MRL Standard, the APVMA will publish a Trade Advice Notice (TAN) inviting comment.

2.7.   Data protection

Applicants must provide a data list, including an entry for all information that meets the definition given on the APVMA website data protection page. This requirement applies irrespective of whether an application is eligible for data protection.

Note that applications which involve assessment of chemistry data require provision of a chemistry data list, and Module 12 (data protection) will apply to these applications.

Module 12 (Data Protection) is required for all applications which are assessed under a modular category, where the applicant provides data to the APVMA that are eligible for protection. This applies to the great majority of applications in this category. Publicly available data are ineligible for protection.

Module 12 covers the cost of steps required to protect data and is mandatory for all applications which provide data eligible for protection. Applicants cannot waive the right to protected data before an application is granted.

Note that applications which involve assessment of chemistry data require provision of a chemistry data list, and the fee for Module 12 (data protection) will apply to these applications if the data are eligible for protection .

Module 12 also applies to secondary applications (see 3.2) which rely on protected data provided for the primary application, or which require assessment of data that are not common with the primary application. Data related only to the secondary product must be included on a separate data list and must not be included on the data list of the primary product application. Data related only to the secondary product cannot be considered required and relied on to grant the primary application and therefore will not receive protection if provided in this manner.

Applicants applying under Category 14 may need to refer to data relied on by the APVMA to register a reference product. The reference product may also have required access to protected data in relation to its active constituent/s or reference product. If the applicant is not the authorising party for the data used to approve the active constituent/s or register the product, the applicant must obtain consent for use from the relevant authorising parties. Applicants can determine whether they are using protected data by checking the product details on the product search facility on the APVMA website.

2.7.1.   Companion animal products

Applications involving companion animal products (for example dogs, cats, horses, aviary birds and aquarium fish), which contain an existing active constituent, are not eligible for data protection and do not require this module. Publicly available data are also ineligible for protection. However, a data list must be provided with all applications.

3.   GUIDELINES

3.1.   Multiple variations

A single Category 14 application may include more than one variation, for example addition of a new target animal species plus a formulation variation. In this situation, only a single screening module and finalisation module, together with the relevant assessment modules, will be required. However, if for example an application requesting multiple extensions of use requires the APVMA to use multiple external efficacy reviewers, multiple efficacy modules (at the appropriate level) will be required to be assigned to the application.

In addition, if the APVMA finds deficiencies relating to only one module, none of the variations contained in the application can be approved until all deficiencies have been addressed satisfactorily, or the deficient use is withdrawn. An additional application including screening, finalisation and any other necessary modules and fees will be required in order to approve the deficient variation if the deficiencies can only be addressed by the provision of new data.

If an applicant wishes to make administrative label variations at the same time as making a Category 14 application, and if these label variations would normally be subject to an application under Category 12 or 13, all of the label variations may be made under a single Category 14 application. There is no need to make a separate Category 12 or 13 application for the administrative label variations.

3.2.   Secondary applications

A secondary application exists where the registrant has another product undergoing the same or similar variation to the first or primary product at the same time, and the assessment of data for the first product can be used for both products (see Category 2).

Secondary applications must be made as separate Category 14 applications. They cannot be made as part of the application to vary the first or primary product.

Secondary applications will generally require less data and assessment than the first or primary application. Data and module requirements for related or secondary applications will depend on the type of product, the type of change, and the required assessments that are not common with the first or primary product.

If the primary application requires one or more assessment modules and no further technical assessments are required for the secondary application, only Modules 1 (Screening) and 11.4 (Finalisation), and where relevant Module 12 (Data Protection), will apply to the secondary applications. If the primary application does not require any assessment modules, only Module 11.4 (Finalisation) will apply to the secondary applications.

Secondary applications will only be finalised after the first or primary product application is finalised.

Note that the product with the highest concentration of active constituent or dose should always be presented as the first or primary application.

4.   SPECIFIC REQUIREMENTS, GUIDELINES AND EXAMPLES

The paragraphs below set out the specific requirements, guidelines and examples for each of the types of application eligible for assessment under Category 14. The examples show how data requirements can be determined by using Data requirements and guidelines in Volume 3.

In the examples, applicants must submit the relevant data as indicated or must provide valid scientific argument why certain data should not be required. If the APVMA accepts that the scientific argument is valid, those data need not be submitted.

4.1.   Variation to the product label claims, including new pests, new diseases or new target animal species

4.1.1.   Variation to, or addition of, a label claim which may involve a new pest or disease in or on the same target animal species

Requirements

Applications to vary or add a label claim, or extend the use of a product to additional pests and/or diseases in or on the same target animal species, require, as a minimum, submission of an Application Overview (Part 1) and supportive target animal efficacy data (Part 8).

Applications of this nature may or may not require associated changes in dosage and administration instructions. If there are associated changes in dosage and administration instructions for using the product in a food-producing animal species, residues and possibly trade data (Part 5) may be required.

If a new use pattern is involved that could result in increased exposure to workers, animal handlers, or to the environment, OHS issues (Part 6) or environmental safety issues (Part 7) should be addressed.

If a new use pattern results in increased target animal exposure, target animal safety data (Part 8) must also be provided.

Other examples under this sub-category, which do not involve a new pest or disease in the same target animal species, include the following:

• inclusion of a rainfastness statement for a topical parasiticide
• increase in the strength of claim from ‘aids in control’ to ‘controls’
• change to a protection period.

Examples

Example 1: An ectoparasiticide dip product is registered for use on cattle. Application is made to extend its use to control an additional species of tick (dose is increased and change to the MRL is required).

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 5.2	Residues – Level 2	$4,765
Module 6.3	OHS – Level 3	$1,435
Module 7.2	Environment – Level 2	$3,255
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$13,110
	Timeframe:	9 months

Example 2: An antibiotic tablet is registered for use in dogs and cats. Application is made to extend its use to include an additional bacterial species (dose unchanged).

Data requirements are expected to be drawn from:

Application Overview	Part 1
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$2,180
	Timeframe:	5 months

Example 3: A clostridial disease vaccine is registered for use in cattle. Application is made to increase the duration of immunity statement (dose unchanged).

Data requirements are expected to be drawn from:

Application Overview	Part 1
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,600
	Timeframe:	6 months

4.1.2.  Extension of the use of a product to a new target animal species

Requirements

Applications to extend the use of a product to a new target animal species will require, as a minimum, submission of an Application Overview (Part 1) and animal efficacy and safety data (Part 8). Residues and possibly trade data (Part 5) will generally be required when the new target species is a food-producing animal, other than for immunobiological or complementary medicine products, for which Part 5 data are generally NOT required.

A toxicological assessment (Part 3) will also be required if an acceptable daily intake (ADI) has not been established (for example where use of the active constituent in a food-producing species has not previously been approved). Metabolism and kinetics data (Part 4) will be required for extensions of use from a non-food-producing to a food-producing animal species (where use of the active constituent in the food-producing species has not previously been approved). If a new use pattern is involved that could result in increased exposure to workers or animal handlers, or to the environment, OHS issues (Part 6) and/or environmental safety issues (Part 7) should be addressed.

Applications for extension of use of antibiotic products to a new target animal species should consider antibiotic resistance. If the Expert Advisory Group on Antimicrobial Resistance (EAGAR) has not previously assessed the antibiotic, applicants must submit a full special data (antibiotic resistance) (Part 10) data package. If the APVMA has not previously approved use of the antibiotic in the new target animal species but EAGAR has previously assessed the antibiotic, scientific argument may be used in appropriate sections of Part 10.

Examples

Example 1: A topical ectoparasiticide spray is registered for use in pigs. Application is made to extend the use to cattle. Use of the active constituent in cattle has not previously been approved, but an ADI has been established.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 5.2	Residues – Level 2	$4,765
Module 6.3	OHS – Level 3	$1,435
Module 7.2	Environment – Level 2	$3,255
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$14,225
	Timeframe:	9 months

Example 2: An antibiotic oral powder is registered for use in dogs and cats. Application is made to extend the use to pigs as an in-feed medication. The APVMA has not previously approved use of the antibiotic active constituent in food-producing animals, OCS has not established an ADI, and EAGAR has not previously assessed the antibiotic.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Toxicology	Part 3
Metabolism and Kinetics	Part 4
Residues and Trade	Part 5
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8
Special Data (antibiotic resistance)	Part 10

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 3.2	Toxicology – Level 2	$14,620
Module 5.1	Residues – Level 1	$5,595
Module 6.3	OHS – Level 3	$1,435
Module 7.2	Environment – Level 2	$3,255
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 10.2	Special Data (antibiotic resistance) – Level 2	$0
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$29,675
	Timeframe:	15 months

Example 3: An antibiotic injection is registered for use in cattle. Application is made to extend the product’s use to include dogs and cats. The APVMA has previously approved use of the antibiotic in dogs and cats for other products.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,600
	Timeframe:	6 months

4.2.   Variation to label restraint statements, contraindications, precautions or side effects statements, or label dosage and administration instructions (treatment number, frequency, duration, dose, route of administration), or withholding period instructions

4.2.1.  Variation to label restraint statements

Requirements

Label restraint statements impose an absolute limitation relating to residues, trade, antibiotic resistance, or environmental issues.

Applications to vary the directions for use of a product may involve deletion, modification or addition of a restraint statement.

Changes to restraints that relate to residues will require a limited residues and trade (Part 5) data package. Submission of additional animal safety data (Part 8) and/or environmental data (Part 7) may also be required if the change has animal or environmental safety implications.

Changes to restraints that relate to antibiotic resistance must address the risk of induction of antibiotic resistance in bacterial strain which may infect humans. If the Expert Advisory Group on Antimicrobial Resistance (EAGAR) has not previously assessed the antibiotic, applicants must submit a full special data (antibiotic resistance – Part 10) data package. If EAGAR has previously assessed the antibiotic, scientific argument may be used in appropriate sections of the Part 10 data.

Changes to restraints that relate to the environment will require a partial Part 7 data package.

Examples

Example 1: An intraruminal anthelmintic capsule is registered for use in cattle. Application is made to delete the restraint (due to residues) that limits administration of the product to only one capsule per animal every six months.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5
Efficacy and Safety	Part 8

The following modules are expected to apply:

4.2.2.   Variation to label contraindications, precautions or side effects stateme

Module	Description	Fee
Module 1	Screening	$505
Module 5.4	Residues – Level 4	$2,230
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$4,580
	Timeframe:	5 months

nts

Requirements

Applications to vary label contraindications, precautions or side effects statements will generally only require submission of an Application Overview (Part 1) and animal safety data (Part 8).

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,350
	Timeframe:	5 months

4.2.3.   Variation to label dosage and administration instructions

Requirements

Applications to vary the label dosage and administration instructions of a product may involve an increase or decrease in the number of treatments, the frequency of treatments, the duration of treatment, the dose, or a change to the route of administration. All of these variations will require submission of an Application Overview (Part 1) and animal efficacy and safety data (Part 8).

Food-producing animal species

Residues and possibly trade data (Part 5) will usually be required when the variation relates to a food-producing animal species and there is an increase in treatment frequency, duration, dose or change of route of administration, other than for immunobiological or complementary medicine products, for which Part 5 data are generally NOT required. Metabolism studies for the active constituent will not be required as part of the residues data because new active constituents are not involved.

Ectoparasiticide products

OHS data (Part 6) and environmental data (Part 7) will be required if the change in dosage/administration is likely to result in a higher level of human exposure and environmental exposure than previously assessed.

Examples

Example 1: An off-shears backline ectoparasiticide product is registered for use in sheep. Application is made for approval of an increased application dose rate to address efficacy concerns. No change in MRL is required.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 5.4	Residues – Level 4	$2,230
Module 6.3	OHS – Level 3	$1,435
Module 7.2	Environment – Level 2	$3,255
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$10,575
	Timeframe:	9 months

Example 2: A heartworm prevention tablet product is registered for use in dogs. Application is made to reduce the interval between prophylactic doses from six weeks to four weeks (ie increased frequency of treatment) for marketing purposes.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$2,180
	Timeframe:	5 months

Example 3: A poultry vaccine is registered for use by direct oral administration to individual birds. Application is made to add an alternative route of administration by ‘mass vaccination by addition to drinking water’.

In-use stability data and efficacy and animal safety data are required for the proposed alternative route of administration.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,800
	Timeframe:	6 months

4.2.4.   Variation to label withholding period instructions

Requirements

Applications to reduce the existing withholding period of a product will require an Application Overview (Part 1) and residues and trade data (Part 5).

Data will be required to demonstrate that expected residue levels in food commodities/treated produce will not exceed the MRL when the product is used in accordance with the proposed new withholding period (Part 5A). If the data indicate that residues will exceed the existing MRL when the product is used according to the proposed new withholding period, the applicant must also propose a new MRL and address trade issues (Parts 5A and 5B).

Metabolism studies for the active constituent will not be required as part of the residues data because new active constituents are not involved.

Examples

Example 1: A flukicide oral drench is registered for use in cattle. Application is made to reduce the meat withholding period. A change to the MRL is not required.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 5.4	Residues – Level 4	$2,230
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$4,080
	Timeframe:	5 months

Example 2: A flukicide oral drench is registered for use in cattle. Application is made to reduce the meat withholding period. A change to the MRL is required.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 5.2	Residues – Level 2	$4,765
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$6,615
	Timeframe:	8 months

4.3.  Variation to the label poisons scheduling (signal heading), first aid, user safety directions, or personal protective equipment statements

4.3.1.   Variation to poisons scheduling

Requirements

Applications to change the poisons schedule of a product that result in a change to the signal heading on the label, and which require assessment of data, will require submission of an Application Overview (Part 1) and toxicology data (Part 3).

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Toxicology	Part 3

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 3.3	Toxicology – Level 3	$2,900
Module 4	Toxicology – Scheduling	$3,720
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$8,470
	Timeframe:	14 months

4.3.2.   Variation to label first aid statements

Requirements

Applications for variations to label first aid statements which require assessment of data will require submission of an Application Overview (Part 1) and a toxicology package (Part 3). Applicants should submit new toxicological data to support the proposed variation, if they are available.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Toxicology	Part 3

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 3.3	Toxicology – Level 3	$2,900
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$4,750
	Timeframe:	6 months

4.3.3.   Variation to label user safety directions

Requirements

Applications for variations to user safety directions (hazard statements) which require assessment of data will require submission of an Application Overview (Part 1), toxicology data (Part 3) and OHS data (Part 6).

New toxicology data to support the proposed variation should be submitted.

Varying the hazard statement may make it necessary to vary the label personal protective equipment statement.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Toxicology	Part 3
Occupational Health and Safety	Part 6

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 3.3	Toxicology – Level 3	$2,900
Module 6.3	OHS – Level 3	$1,435
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$6,185
	Timeframe:	6 months

4.3.4.   Variation to label personal protective equipment statements

Requirements

Applications to vary label personal protective equipment statements which require assessment of data will require submission of an Application Overview (Part 1) and OHS data (Part 6).

If the justification for the variation requires toxicological assessment, toxicological data (Part 3 – partial) and Module 3.3 (Toxicology – Level 3) will also apply.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Occupational Health and Safety	Part 6

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 6.3	OHS – Level 3	$1,435
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$3,285
	Timeframe:	6 months

4.4.   Variation to label environmental safety statements, including disposal instructions

Requirements

Applications to delete, modify, or add label environmental safety statements which require assessment of data will require submission of an Application Overview (Part 1), and where the proposed variations meet criteria for VICH Phase II, environmental safety data (Part 7).

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Environment	Part 7

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 7.3	Environment – Level 3	$620
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,470
	Timeframe:	6 months

4.5.   Minor variation to product details

Consistent with validation of variations under the Codes of Good Manufacturing Practice, the applicant must conduct stability trials using samples from a production batch of the varied product. If submission of this data is not mandatory and not available at the time of making an application to vary the product details, the data from these stability trials must be assessed by the registrant, and the APVMA must be advised promptly should test results not comply with the approved product specifications.

If stability data are not available, the APVMA may assign a reduced shelf life until real time data are provided. For more information on stability trials, refer to Guidelines for the Generation of Storage Stability Data of Veterinary Chemical Products - Guideline No. 68 (PDF, 197kb) and other chemistry guidelines in Volume 4.

4.5.1.   Minor variations to active constituent details will be assessed under Category 14, not Category 18

Data requirements for an application to vary the active constituent details will vary depending on the type of product and the nature of the changes.

The application should be made under Category 18 if:

• if the active constituent is an approved active constituent that has protection under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement (refer to Active Constituents Subject to TRIPS Protection).
  or

• if the active constituent is an ectoparasiticide which is an approved active constituent for use in agricultural chemical products (refer to Vet MORAG Category 17).

The application should be made under category 14 if the active constituent does not fit the description above and is contained in a registered veterinary chemical product.

Pharmaceuticals

If the specifications of the active constituent are varied, and the varied specifications of the active constituent comply with the current version of an acceptable compendial standard (BP, BPvet, Ph Eur, USP), the registrant need only submit to the APVMA written advice of the varied specification. If the active constituent does NOT meet an acceptable compendial standard, application to vary the specifications of the active constituent must be made under Category 14.

In the case of variation to the site of manufacture (source) of the active constituent, where the specification is unchanged or complies with an acceptable compendial standard, the registrant need only submit to the APVMA written advice of the varied source of the active constituent.

Variation to manufacturing process, where the source is unchanged, and the specification is unchanged, does not require an application or written advice to the APVMA.

Immunobiologicals , peptides, DNA constructs etc (bioassay required)

Applications to vary the specifications, site of manufacture (source) or manufacturing process of active constituents must be made under Category 14. For further information refer to the guidelines for these product types or contact the APVMA.

For immunobiologicals, refer to Guideline 49: Data requirements and guidelines for variations to immunobiological products in Volume 4.

Complementary medicines: – herbals, direct-fed microbials, etc

Applications to vary the specifications, site of manufacture (source) or manufacturing process of active constituents must be made under Category 14. For further information refer to the guidelines for these product types or contact the APVMA.

NOTE 1: For all of the product types above, if product specifications are changed as a result of a variation to the active constituents, the application will be assessed as a variation to product specifications (see paragraph 4.5.8 ).

Requirements

Applicants must specify the proposed variations in the relevant section of the Application Overview (Part 1). The Part 1 submission must include a new formulation table, a copy of the unchanged product specifications, and any new specifications for raw materials.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Note that if the variation to the active constituents has the potential to affect product safety or efficacy, even when the product specifications are unchanged, further data Parts and modules may be required.

If a manufacturer's specification meets an acceptable pharmacopoeial standard (ie has all the same testing requirements and test limits) and does not delete or substitute a pharmacopoeial test, this will be accepted without requiring a chemistry assessment module. Other tests in addition to those shown in the pharmacopoeial standard are permitted.

4.5.2.   Variation to the concentration of, or substitution, addition or deletion of, non-active constituents

In applications of this nature, the new formulation must remain similar to the old formulation, and the product specifications must remain unchanged.

If product specifications are changed as a result of this variation, the APVMA will assess the application as a variation to product specifications (see paragraph 4.5.8).

For certain defined variations to non-active constituents in pharmaceutical products, an application may be made under Category 12. For all other variations, an application under Category 14 is required.

Immunobiological or peptide products

Variations including substitution, addition, deletion or alterations in concentration of the preservative, the stabiliser of freeze-dried products, and the cryoprotectants of the final product, all require application under Category 14. Further guidance is available in Guideline 49: Data requirements and guidelines for variations to immunobiological products in Volume 4.

Requirements

Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1). The Part 1 submission must include a new formulation table and a copy of the unchanged product specifications.

When available, stability data on trial batches should be provided in the chemistry and manufacture submission (Part 2).

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

As a minimum, the following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Note: If the variation to non-active constituents has the potential to affect product safety or efficacy, such as a change to a synergist or adjuvant, further data Parts and modules may be required.

Examples

Example 1: Application is made to change the proportions of excipients in a live attenuated viral vaccine product for use in dogs. No constituents are to be removed or new ones introduced – only the relative proportions of the non-active constituents are to be varied. Stability and in-use stability data have been included in the chemistry submission, and data have been generated using the varied formulation to demonstrate comparable efficacy and animal safety with the previously approved formulation.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$2,380
	Timeframe:	5 months

4.5.3.   Variation to specifications and/or source of non-active constituents

Pharmaceuticals (chemical assay required)

For all non-active constituents of biological origin, an application to vary the source is required. For other non-active constituents, an application to vary the source is NOT required.

If the varied specification of the varied non-active constituents conforms to an acceptable compendial standard (BP, BPvet, Ph Eur, USP), the registrant need only submit to the APVMA written advice of the varied specification.

If the specification does not conform to an acceptable compendial standard, an application under this Category 14 is required, if the varied formulation remains similar to the previous formulation and the product specifications remain unchanged.

Immunobiologicals, peptides, DNA constructs etc (bioassay required)

For all non-active constituents of biological origin, an application to vary the source is required. For other non-active constituents, an application or advice to vary the source is NOT required.

For immunobiological or peptide products, variations to specifications of non-active constituents require an application under Category 14. For further information refer to the guidelines for these product types or contact APVMA. Further guidance is available in Guideline 49: Data requirements and guidelines for variations to immunobiological products in Volume 4.

Complementary medicines – herbals, direct-fed microbials, etc

The requirements for these products are the same for pharmaceutical products, above.

NOTE 1: If product specifications are changed as a result of a variation to the non active constituents, the application will be assessed as a variation to product specifications (see paragraph 4.5.8).

NOTE 2: Applications to vary the specifications of active constituents must be made according to paragraph 4.5.1.

Requirements

Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1). The Part 1 submission must include a new formulation table, a copy of the unchanged product specifications, and new specifications for raw materials.

When available, stability data on trial batches should be provided in the chemistry and manufacture (Part 2) submission.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Note that if the variation to non-active constituents has the potential to affect product safety or efficacy, such as changes to synergists or adjuvants, further data Parts and modules may be required.

If a manufacturer's specification meets an acceptable pharmacopoeial standard (ie has all the same testing requirements and test limits) and does not delete or substitute a pharmacopoeial test, this will be accepted without requiring a chemistry assessment module. Other tests in addition to those shown in the pharmacopoeial standard are permitted.

In this case data requirements are expected to be drawn from:

Application Overview

Part 1

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$665
	Timeframe:	2 months

4.5.4.   Variation to the immediate container (packaging material and/or closure system)

Requirements

Assessment of stability data is required if there is a change to the packaging material of the immediate container. Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1).

The chemistry and manufacture (Part 2) submission should include stability data, sterility verification (where appropriate) and container/closure specifications.

If a new container requires novel disposal instructions, environmental safety (Part 7 – partial) data and a Module 7.3 (Environment – Level 3) assessment may also be required.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

4.5.5.  Variation or addition of an overseas site of manufacture of a product (formulator), where the new site is not licensed by the APVMA

The manufacturing process and product formulation may also be varied as a part of an application of this nature. However, the manufacturing process must remain very similar to that of the previous site, and the product specifications must remain unchanged.

If product specifications are varied, the application will be assessed according to paragraph 4.5.8.

Requirements

Applicants must specify the proposed variations and provide evidence of compliance with good manufacturing practice (GMP), such as a certified copy of a certificate of GMP compliance from a recognised authority, an audit report from a recognised authority or proof that the APVMA has recently accepted such evidence. This evidence together with the product specifications must be provided in the Application Overview (Part 1).

If the new site has been formulating the same product for some time (eg for marketing in another country), stability data to support the existing shelf life must be included in the chemistry and manufacture data (Part 2).

If the new site has only recently started to manufacture the product and stability data are not yet available, certificates of analysis comparing product from the old site with product from the new site and validation data if required, must be included in the chemistry and manufacture data (Part 2). The registrant must assess data from stability trials, and must promptly advise the APVMA if test results do not comply with the approved product specifications. The APVMA may assign a reduced shelf life until real time data are provided.

For immunobiological or peptide products, chemistry and manufacture data (Part 2) must also include a summary of relevant standard operating procedures for the old and the new proposed processes, and a declaration that in-process testing remains unchanged.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Note that if the variation to non-active constituents involves a variation which has the potential to affect product safety or efficacy, further data Parts and modules may be required.

Changes of site of manufacture of immunobiological and peptide products will require demonstration of comparable efficacy and animal safety with vaccine manufactured at previously approved sites (eg results of potency testing).

Examples

Example 1: An attenuated live viral vaccine is registered for use in dogs. Application is made to add an alternative overseas site of manufacture of the vaccine. The site of manufacture of the viral active constituents remains unchanged. The applicant has provided appropriate chemistry and manufacturing data and the product specifications remain unchanged. The applicant has provided results of potency testing to demonstrate comparable efficacy and safety with the vaccine produced by the currently-approved formulator.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$2,380
	Timeframe:	5 months

Example 2: An attenuated live viral vaccine is registered for use in dogs. Application is made to change the overseas site of filling and packaging only. Packaging materials are unchanged. There are no changes to other manufacturing steps. Test results have been provided to demonstrate compliance with unchanged batch release specifications.

Data requirements are expected to be drawn from:

Application Overview

Part 1

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$665
	Timeframe:	2 months

4.5.6.   Extension of shelf life

Applications to extend the shelf life of a product where the product specifications remain unchanged will, as a minimum, require stability data to support the proposed change.

If product specifications are changed as a result of this variation, the application will be assessed as a variation to product specifications (see paragraph 4.5.8).

Requirements

Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1) and must include the product specifications and any other relevant documentation.

Chemistry and manufacture data (Part 2) must include the test results for the stability trial.

Products which are presented in multiple dose containers (eg injection vials, multi-dose pastes and eye and ear drops or lotions) must have an in-use shelf life or appropriate discard statement on the product label. The APVMA will assess applications to extend the in-use shelf life of products in multiple dose containers under this section of Category 14. Applicants must submit broached vial or other in-use stability data. Variation to the in-use shelf life statement on the product label will also be required, and this variation can be done under this single application.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

4.5.7.   Variation to the manufacturing process where the product specifications are not changed

Variation to the manufacturing process of pharmaceutical (non-biological) products, where the active constituent is not changed and is the subject of an acceptable pharmacopoeial monograph, do not require an application unless product specifications are changed.

If product specifications are changed as a result of the variation, the application will be assessed as a variation to product specifications (see paragraph 4.5.8).

An application will be required for all biological products, unless an exemption is otherwise specified.

For immunobiologicals, further guidance is available in Volume 4: Guidelines (Guideline 49 for immunobiologicals).

Requirements

Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1) and must include a copy of the product specifications and any other relevant documentation.

Chemistry and manufacture data (Part 2) must include any relevant standard operating procedures (SOP) for the old and the proposed new processes, and validation data if required.

Applicants must also provide evidence that GMP approval encompasses the additional or altered steps in the manufacturing process.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

The APVMA will assess variations to the manufacturing process of immunobiological or peptide products on a case-by-case basis to determine whether or not further technical assessment is required. If variations to the process involve changes to a critical or decision-making potency or safety test (eg use of different aged target species animals from those shown on the product label), further data parts and modules may be required in addition to validation data.

Examples

Example 1: A clostridial vaccine is registered for use in sheep. Application is made to change several manufacturing processes. SOPs have been provided for the new processes and validation data have been provided to demonstrate that the product specifications remain unchanged. The applicant has provided results of potency testing to demonstrate comparable efficacy and safety with the vaccine produced according to previous manufacturing processes.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,550
	Timeframe:	5 months

4.5.8.   Variation to product specifications

Product specifications include full details of all test methods and limits for the QA testing for batch release and expiry. Unless the batch release and expiry specifications are identified and described separately, the APVMA will assume they are the same.

The APVMA will assess variations to the product specifications on a case-by-case basis to determine whether or not further technical assessment is required. Normally, a variation in product specification will at least require stability data to support the proposed variation.

Further data parts and modules may be required in addition to validation data if variations to product specifications involve changes to purity or potency test limits. For example, increase in maximum release titre of an immunobiological product could influence product safety, while a decrease in end-of-shelf-life titre could influence product efficacy, and a change in minimum release titre could affect the approved product shelf life. Part 8 data will be required if such changes in release titre are expected to affect efficacy and/or safety.

The APVMA will assess applications to reduce the shelf life of an immunobiological product by decreasing the minimum release titre (ie reduced overage to the expiry/efficacy titre) under Category 14.

Refer to paragraph 4.5.7. for variations to the manufacturing process of immunobiological or polypeptide products if product specifications remain the same.

Requirements

Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1) and must include the product specifications and any other relevant documentation. Chemistry and manufacture data (Part 2) must include the test results for the stability trial, and validation data where required.

In the case of vaccine products, if a reference batch is used and no adjustment to that reference is required, applicants must submit amended batch release specifications, real time stability data for the vaccine components and reconstitution stability data (if applicable). If a reference batch is to be adjusted, applicants must also submit full stability data for the vaccine components of the reference vaccine and vaccine product.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Note that if the variation to batch release or expiry specifications involves a change which has the potential to affect product safety or efficacy, further data Parts and modules may be required.

Examples

Example 1: A clostridial vaccine is registered for use in cattle. Application is made to decrease the minimum release titre without a reduction in end-of-shelf-life titre. The applicant has provided stability data.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Example 2: A clostridial vaccine is registered for use in cattle. Application is made to decrease the maximum release titre because of manufacturing problems.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,550
	Timeframe:	5 months

Example 3: Application is made to vary the manufacturing process for an intramammary infusion product. Viscosity testing is currently performed only as an in-process quality control procedure. The proposed variation involves introduction of viscosity testing as part of the final product release specifications. The applicant has provided validation data. This variation would likely be assessed at screening.

Data requirements are expected to be drawn from:

Application Overview

Part 1

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$665
	Timeframe:	2 months

Example 4: Application is made to vary the manufacturing process for an intramammary infusion product. The variation involves removal of viscosity testing from in-process quality controls. Viscosity will still be tested as part of the final product release specifications.

Application to the APVMA is not required because the product specifications are unchanged.

4.6.   Any other variation to label and/or minor variation to product details not specified above

Examples of variations of this nature which application must be made under Category 14 are:

• variations to a diluent that is wrapped and supplied with a vaccine. Diluent variations will require a limited assessment of data, and label variations may be required
• variations in storage temperature which require technical assessment. Applications to increase the storage temperature (eg from air conditioning to room temperature) will require submission of stability data and an associated variation to the storage statement on the product label
• variation or addition of a local Australian site of manufacture of an immunobiological product (formulator), where the new site is licensed by the APVMA. Data requirements are the same as for variations involving overseas sites of manufacture (see paragraph 4.5.4), except that evidence of good manufacturing practice (GMP) compliance is limited to provision of the APVMA manufacturer’s licence number.

Guidelines

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Examples

Example 1: A freeze-dried vaccine for cats is registered for use by reconstitution using phosphate buffered saline. The vaccine is administered immediately after reconstitution. The diluent is not packaged with the vaccine. Application is made to add the recommendation that sterile saline can also be used as the diluent. The applicant has provided validation data in the form of in-vitro potency testing to demonstrate that reconstitution with either diluent results in comparable titres.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$865
	Timeframe:	5 months

Example 2: An attenuated live viral vaccine is registered for use in dogs. Application is made to change the local site of filling and packaging only, to a different Australian site. Packaging materials are unchanged. There are no changes to other manufacturing steps. The applicant has provided test results to demonstrate compliance with unchanged batch release specifications.

Data requirements are expected to be drawn from:

Application Overview

Part 1

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 11.4	Finalisation – Type 4	$160
	Total fee:	$665
	Timeframe:	2 months

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