Veterinary Manual of Requirements and Guidelines - Vet MORAG

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Category 7 Application

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 7 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 closely similar to a registered chemical product; and
  2. efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and
  3. chemistry and manufacture data are not required.

Category 7 applications are applications for registration of an ‘image’ product containing approved active constituents, and approval of the product label, where the product is closely similar to an APVMA-registered reference product and chemistry and manufacture data are NOT required. Other data for technical assessment are also NOT required because the formulation and use pattern of the reference and ‘image’ product are closely similar, and the products would be expected to be equivalent in terms of their efficacy and host animal safety, residues and trade, environmental safety, human health and occupational health and safety.

The criteria for a product to be considered eligible for assessment under Category 7 (see paragraph 1.1) are less stringent than those for Category 8, but more stringent than those for Category 6. For example, if the proposed and reference products do not have the same formulators or immediate container (packaging materials and closure system), but other criteria in paragraph 1.1 are met, chemistry data would be required and the application may be eligible for assessment under Category 6. 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 10 Category 8 Category 5 Category 6 Category 7

1.1.   Definition of closely similar veterinary products

Applications to register new products under Category 7 are those where the formulation and label instructions of the new product are closely similar to those of a registered reference product, and no data is required to demonstrate product quality, consistency, stability or target animal efficacy and safety.

For a new product to be considered closely similar to a registered reference product and NOT require chemistry and manufacture data, and so be eligible for assessment under Category 7, 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 constituents must be the same
  • the non-active constituents must be the same or equivalent substances at the same or equivalent concentrations1
  • the product specifications (release and expiry limits and test methods) and physico-chemical properties (including pH, particle size and crystal form) must all be the same or equivalent1
  • the dose form/ formulation type must be the same
  • the use pattern (including target animal species, dose rates, route of administration, withholding periods), label claims and label instructions must all be the same, however there may be fewer or reduced claims compared with the reference product
  • the immediate container must be the same (same packaging materials and closure systems)1
  • the site of product manufacture must be the same (same site of manufacture using the same equipment).

Examples of product types which may be eligible for application under Category 7 include products which are the same as the reference product, but fall outside the definition of Category 8 (repack) because of differences which may include:

  • additional pack sizes
  • minor change in formulation
  • fewer or reduced claims compared with the reference product
  • other label changes (apart from product name and registrant details) compared with the reference product.

If the formulation, specifications or pack size or label instructions of the proposed product are sufficiently different from those of the reference product, the APVMA may determine that the application requires submission of data for technical assessment, for example chemistry, toxicology, residues and trade, OHS, environment or efficacy and host animal safety data.

Differences that have the potential to affect product quality or other aspects such as efficacy, safety and residues are outside the scope of a Category 7 application, and data will be required for technical assessment under another category. In this instance the APVMA may consider that assessment under Category 5 or 6 or 10 is required.

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 7 and may be assessed under modular Category 10.

Where possible the original pioneer product should be used as the reference product for Category 7 applications.

2.   REQUIREMENTS

When making a Category 7 application for registration of a new product, applicants must provide:

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 7 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.

Sub-part 1.2 of the Application Overview must specify and justify all minor differences in formulation, product specifications and pack size compared with the reference product.

Applicants must provide brief argument in sub-parts 1.3–1.10 why Part 3–10 data are not required.

2.2.   Data

Data are not required for Category 7 applications.

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 7 application is $1,315.

The timeframe is three months.

2.5.   Shelf life

If the Category 7 application for registration is approved, the new product will be assigned a shelf life which is the same as that of the reference product. A shorter shelf life will be assigned where the applicant has proposed this, or where there are concerns about stability. This shelf life will determine the expiry date on the label.

The registrant will be required to conduct stability trials using samples from a production batch of the product in containers of the same material as the marketing container/s to verify the assigned shelf life. Data from these stability trials must be self-assessed by the registrant, and the APVMA must be advised promptly should test results not comply with the approved product specifications. For more information on stability trials, refer to the APVMA’s Chemistry and manufacture (stability) guidelines.

2.6.   Data protection

Data are not required for Category 7 applications therefore a data list is not required.

However, applicants under Category 7 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 applicant is not the authorising party for the data used to approve the active constituents or register the products, 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.

3.   EXAMPLES

Example 1: Application is made for registration of a new non-steroidal anti-inflammatory oral tablet product for use in dogs. The proposed new product is manufactured by the same formulator and is exactly the same as the reference product except for a different brand name and the addition of a suitable colouring agent, which changes the formulation and tablet appearance specification.

This application would be assessed under Category 7 because the addition of a suitable colouring agent is a minor formulation change which is unlikely to have implications for product quality or other risk areas.

Example 2: Application is made for registration of a new vaccine product for use in cattle. The proposed new product is manufactured by the same formulator and is exactly the same as the reference product except for a different brand name and a reduced claim.

This application would be assessed under Category 7, because although immunobiological products are generally ineligible for assessment under Category 7, in this case the proposed and reference products have the same formulator and are pharmaceutically identical.

Example 3: Application is made for registration of a new non-steroidal anti-inflammatory oral tablet product for use in dogs. The proposed new product is exactly the same as the reference product except for a different brand name and the tablet shape specification has changed from round to irregular.

This application would not be assessed under Category 7 because a change in tablet shape from oval to irregular may affect the disintegration and dissolution profile, which could reduce product efficacy. Additional data would be required and assessment of the application under Category 10 may be appropriate.

Example 4: Application is made for registration of a new topical spot-on product for use on dogs and cats to control fleas. The proposed new product is exactly the same as the reference product except for a different brand name and an additional larger pack size (larger vial). The active constituent is scheduled in the SUSDP according to pack size.

This application would not be assessed under Category 7 because the larger vial/pack size has implications for toxicology, poisons scheduling, occupational health and safety and animal safety. Additional data would be required and assessment of the application under Category 10 may be appropriate.

Example 5: Application is made for registration of a new anticoccidial premix product for use in poultry. The proposed new product is exactly the same as the reference product except for a different brand name and substitution of the calcium carbonate carrier with a cereal carrier.

This application would not be assessed under Category 7 because substitution from non-cereal to cereal carrier (or vice versa) is a minor formulation change that requires submission of supporting stability data. Additional data would likely be required and assessment of the application under Category 10 may be appropriate.

FOOTNOTES

  1. All minor differences in formulation, specifications or pack size must be specified and justified. Minor differences may be acceptable if they are described in Minor variations to non-active constituents in Category 12. The acceptability of any differences will be determined at screening on the basis that they would not have adverse implications for product quality or other aspects such as efficacy, safety and residues.

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: deletion of reference to pharmaceutical equivalence
  • 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 (ineligible product types) deleted.
1 July 2007

Fourth edition

  • paragraph 1.2: refer to pioneer reference product
  • paragraph 2.2: new paragraph added to state that data are not required
  • paragraph 2.3: revised label requirements
  • minor text edits.