Veterinary Manual of Requirements and Guidelines - Vet MORAG

APVMA logo

Category 5 Application

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 5 application as:

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

  1. the chemical product is similar to a registered chemical product; and
  2. chemistry and manufacture, efficacy and target species safety data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product.

Category 5 applications do NOT require technical assessment of any data other than chemistry and manufacture, efficacy and target animal safety. Because the formulation and use pattern of the reference and proposed product are similar, the products would be expected to be equivalent in terms of their environmental safety, human health and occupational health and safety.

The criteria for a product to be considered similar to a reference product and eligible for assessment under Category 5 are less stringent than those required for Categories 6, 7 and 8. If assessment is required of data other than chemistry and manufacture, comparative efficacy and target animal safety, the application would be assessed under Category 10. The flowchart below shows how an application may fit into categories 5, 6, 7, 8 or 10:

Flowchart shows how an application may fit into categories 5, 6, 7, 8 or 10. Category 6 Category 7 Category 10 Category 8

 

1.1.   Definition of similar veterinary products

Applications to register new products under Category 5 are those where the formulation and label instructions of the new product are similar to those of a registered reference product, but there are sufficient differences to require part 2 chemistry and manufacture data to demonstrate product quality, consistency and stability, plus part 8 target animal efficacy and safety data to demonstrate that the new product is bioequivalent to the reference product. The new product must meet all of the following criteria:

  • the active constituents must be the same substances (the same APVMA-approved active constituents) and the concentration of active constituent/s must be the same
  • the non-active constituents must have similar properties to those in the reference product and be in similar proportions1
    • data will be required to demonstrate similarity of the proposed product to the reference product
  • the dose form or formulation type must be the same

  • the use pattern (including target animal species, dose rates, route of administration, withholding periods), and label instructions must all be the same
  • the label claims must not exceed or be inconsistent with those of the reference product2
    • however, there may be fewer or reduced claims compared to the reference product.

Examples of product types which may be eligible for application under Category 5 include products which are similar to the reference product, but fall outside the definition of Category 6 (closely similar) due to differences which may include:

  • differences in non-active constituents
  • differences in product specifications and physico-chemical properties.

If the APVMA determines that the proposed product is not similar to the nominated reference product, for example due to differences in the formulation or label instructions or uses, additional data and assessments may be required. In this case the APVMA will inform the applicant that the submission is outside the scope of Category 5 and application under a different category is required. For example, if the formulation or label instructions/uses are significantly different and require other types of assessment (eg toxicology, residues and trade, OHS or environment), the application would be assessed under Category 10.

1.2.   Reference product

A reference product is a chemical product which is registered under Part 2 of the Agvet Code, and has an approved label. It does not include a product for which the registration has been cancelled or a product which is the subject of an application for registration.

If an applicant nominates a reference product for which registration has been stopped or cancelled, the application would be ineligible for Category 5 and may be assessed under modular Category 10.

Where possible the original pioneer product should be used as the reference product for Category 5 applications.

1.3.   Product types which are ineligible for assessment under Category 5

The following types of products cannot generally be considered similar to a reference product and so are ineligible for assessment under Category 5:

  • immunobiological products
  • polypeptide products, DNA constructs and biological delivery systems
  • direct-fed microbial/enzyme products.

Assessment of food-residues studies (under Part 5) which have been undertaken using the proposed product, will generally be required where the new product is for use in a food-producing animal and has one of the following dose forms:

  • non-aqueous products for injection by subcutaneous and/or intramuscular routes
  • intramammary infusions for use in dry cows
  • pour-on formulations
  • implants
  • intraruminal devices.

These dose forms are therefore ineligible for assessment under Category 5 because the definition of a Category 5 application is one for which chemistry and manufacture, efficacy and target species safety data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product.

For other dose forms, scientifically valid arguments may be considered to demonstrate that expected residues resulting from use of the product will not exceed the established Australian maximum residue limits (MRL) for the active constituents.

2.   REQUIREMENTS

When making a Category 5 application for registration of a new product, applicants must provide:

  • one unbound copy of the combined Application Form and Application Overview (refer to paragraph 2.1)
  • one bound copy of each of the relevant data Parts (refer to paragraph 2.2)
  • the product label (refer to paragraph 2.3)
  • the relevant fee (refer to paragraph 2.4)
  • a data list (refer to paragraph 2.5).

2.1.   Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25_F25). 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 5 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-part 1.1 must include details of the reference product.

Applicants must provide a statement under the appropriate heading with brief argument why data are not required for each sub-part 1.3–1.7 and 1.9–1.10.

2.2.   Data

Data requirements for Category 5 applications are as follows:

Description Data part Equivalent3 module level
Chemistry and Manufacture Part 2 Module 2.3
Efficacy and Safety Part 8 Module 8.3

Detailed Part 2 and Part 8 data requirements can be determined by reference to Volume 3: Data requirements and guidelines.

2.2.1.   Efficacy and safety

The efficacy and target animal safety data required to demonstrate similarity to a registered reference product generally correspond with those described for a Module 8.3 assessment in Module levels for modular categories in Volume 3.

The target animal efficacy and safety submission (Part 8) must contain data to demonstrate similarity of the proposed product to the Australian-registered reference product. Comparable efficacy with the reference product may be demonstrated using one of the following:

  • blood level bioequivalence studies
  • measurement of physiological end-point studies
  • clinical studies in the target animal species.

If data are submitted from studies conducted overseas, using products that are registered in other countries but not in Australia , applicants must provide evidence or data to demonstrate that the overseas ‘reference’ product is the same as the Australian-registered reference product.

Where a non-active constituent is different from that in the reference product, tissue irritancy studies may be required and confirmation of the margin of safety may be necessary.

Applications that include efficacy claims additional to those on the label of the reference product are ineligible for Category 5 and will be assessed under modular Category 10.

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:

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

The fee for a Category 5 application is $3,655.

The timeframe is five months.

2.5.   Data protection

Data protection applies for all applications which are assessed under Category 5, where the applicant is providing data to the APVMA that are eligible for protection. Publicly available data are ineligible for 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.

Applicants under Category 5 may need to refer to data relied on by the APVMA to register the reference product. The reference product may also have required access to protected data in relation to the active constituents or its reference product. Where the Category 5 applicant is not the authorising party for the data used to approve the active constituents 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 (PUBCRIS) on the APVMA website.

2.5.1.   Companion animal products

Applications involving companion animal products (for example products for dogs, cats, horses, aviary birds and aquarium fish), which contain an existing active constituent, are not eligible for data protection. Publicly available data are also ineligible for protection.

3.   EXAMPLES

Example 1: Application is made for registration of a new anthelmintic oral paste product for use in horses. Compared with the reference product, the proposed new product has the same concentration of the active constituent. The non-active constituents are not the same as in the reference product, but have similar functions and are present in comparable proportions.

The use pattern and claims of the two products are the same. The applicant has conducted clinical trials in horses against key helminth species to demonstrate comparable efficacy with the reference product and animal safety.

An application of this nature would be assessed under Category 5 because assessment of only chemistry and manufacture, efficacy and animal safety data would be required.

Example 2: Application is made for registration of a new antibiotic product for use in dogs and cats by intramuscular or subcutaneous injection. Compared with the reference product the proposed new product has the same concentration of the active constituent. The non-active constituents are not the same as in the reference product, but have similar properties and are present in comparable proportions. The use pattern and claims of the two products are the same.

The applicant has conducted blood level bioequivalence studies in dogs and cats to demonstrate comparable efficacy with the reference product. Animal safety has been addressed by conduct of tissue irritancy studies in dogs and cats.

An application of this nature would be assessed under Category 5 because assessment of only chemistry and manufacture, efficacy and animal safety data would be required.

Example 3: Application is made for registration of a new anthelmintic drench product for use in sheep. Compared with the reference product the proposed new product has the same concentration of the active constituent. The non-active constituents are not the same as in the reference product, but have similar properties and are present in comparable proportions. The use pattern and claims of the two products are the same.

The applicant has conducted clinical trials in sheep against key helminth species to demonstrate comparable efficacy with the reference product and animal safety. Residues data are not required for this oral formulation.

An application of this nature would be assessed under Category 5 because assessment of only chemistry and manufacture, efficacy and animal safety data would be required.

Example 4: Application is made for registration of a new ectoparasiticide pour-on product for use on cattle. Compared with the reference product the proposed new product has the same concentration of the active constituent. The non-active constituents have similar properties and are present in comparable proportions. The use pattern and claims of the two products are the same. The proposed ectoparasiticide product also contains a new source of the active constituent.

An application of this nature would not be assessed under Category 5 because residues data are required for this pour-on formulation. Application under modular Category 10 would be appropriate.

Example 5: Application is made for registration of a new non-steroidal anti-inflammatory tablet product for use in dogs. Compared with the reference product the proposed new product has the same concentration of the active constituent. The non-active constituents are not the same as in the reference product, but have similar properties and are present in comparable proportions. The use pattern and claims of the two products are the same. The applicant has requested a bioequivalence waiver. The applicant has provided in vitro comparative dissolution data using the proposed and reference products, and scientific argument to justify the request for exemption from bioequivalence studies. Animal safety has been addressed by scientific argument, based on the nature of the non-active constituents.

An application of this nature would be assessed under Category 5 because assessment of only chemistry and manufacture, efficacy and animal safety data would be required.

Example 6: Application is made for registration of a new hormonal implant product for use in cattle by subcutaneous injection. Compared with the reference product the proposed new product has the same concentration of the active constituent. The non-active constituents are not the same as in the reference product, but have similar properties and are present in comparable proportions. The use pattern and claims of the two products are the same. The applicant has conducted blood level bioequivalence studies in cattle to demonstrate comparable efficacy with the reference product. Animal safety has been addressed by conduct of a tissue irritancy study.

Assessment of residues data is required for implant dose forms in food-producing animals. This application is outside the scope of Category 5 and requires assessment under Category 10.

Example 7: Application is made for registration of a new topical ointment product for use on dogs, cats and horses as an antibacterial, anti-inflammatory and anti-fungal medication for skin diseases. Compared with the reference product the proposed new product has the same concentration of the active constituents. The non-active constituents are not the same as in the reference product, but have similar properties and are present in comparable proportions. The use pattern and claims of the two products are the same except that the reference product is approved for use in dogs and horses only. The applicant has conducted clinical trials in dogs and horses against key dermal pathogens to demonstrate comparable efficacy with the reference product and animal safety. Additional efficacy and safety studies have been performed to support the claim for use on cats.

The proposed product is not similar to the reference product because of the different use pattern (use on cats). This application is outside the scope of Category 5 and requires assessment under Category 10.

FOOTNOTES

  1. Data will be required to demonstrate similarity of the proposed product to the reference product.
  2. There may be fewer or reduced claims compared with the reference product.
  3. Category 5 is a fixed category for which the fee and timeframe are predetermined. Although Category 5 is not a modular category, the chemistry and manufacture data required correspond with those described for a Module 2.3 assessment in Module levels for modular categories in Volume 3.

REVISION HISTORY

Revision Date Description of Revision
1 July 2005 First edition

1 October 2005

Second edition

  • hyperlinks inserted to Labelling Code, SUSDP and FAISD handbook
1 April 2006

Third edition

  • paragraph 1.1: moved paragraph from 1.2 on products not similar
  • paragraph 1.2: added statement that a product which is the subject of an application for registration cannot be a reference product
  • paragraph 1.3: added exclusions for DNA constructs and biological delivery systems
  • paragraph 2: added reference to data list.
1 July 2007

Fourth edition

  • paragraph 2.3: revised label requirements
  • paragraph 2.5: removed inaccurate reference to Module 12. E dited to state that applicants must provide a Data List for chemistry and manufacture data
  • minor text edits.