You are here

Separate and distinct biologicals

Australian Regulatory Guidance for Biologicals (ARGB)

27 July 2018

This document will assist you to determine whether your products are separate and distinct biologicals. Where the characteristics are deemed to be separate and distinct products will be need to be included as separate entries on the ARTG. The characteristics are different for Class 1 or Class 2 compared with Class 3 or Class 4 biologicals.

Characteristics for separate and distinct goods

Class 1 or Class 2 biologicals

For class 1 or class 2 biologicals, if any of the following characteristics differ from the other biological, then they must be included as separate and distinct products in the ARTG:

Examples of separate and distinct biologicals (multiple ARTG entries)

Example 1: A tissue bank wants to supply the following class 2 biologicals:

  • musculoskeletal and
  • ocular tissue.

As different standards apply to each tissue type, namely TGO 83 (Standards for human musculoskeletal tissue) and TGO 85 (Standards for human ocular tissue), these are separate and distinct goods. Both of these products would need to be included as separate entries in the ARTG.

Example 2: A Sponsor of class 2 musculoskeletal tissue, milled femoral head, frozen, irradiated, wants to add a second principal manufacturing site for their tissue (e.g. a principal manufacturer in Brisbane as well as in Perth). These products may be manufactured under the same product specific standard, and have the same intended use, but the manufacturer represents two 'principal manufacturers', so these products would require separate ARTG entries.

Example of biologicals not separate and distinct (single ARTG entry)

A tissue bank (single manufacturer) wants to supply the following:

  • Product A: segmented bone, frozen, irradiated; and
  • Product B: milled femoral head, frozen, non-irradiated.

Where the same standards (TGO 83 and TGO 88) apply, they have the same intended clinical use and are produced by the same manufacturer both Products A and B could be included in a single ARTG entry. In this example, it is possible that a number of different forms of the bone grafts may even be included within the single products mentioned. For example, the segmented bones may vary in the length and form (e.g. strut, wedge, and shaft).

Class 3 or Class 4 biologicals

For class 3 or class 4 biologicals, if any of the following characteristics differ from the other biological, then they must be included as separate and distinct products in the ARTG:

  • product name
  • dosage form
  • formulation or composition
  • therapeutic indication
  • type of container, regardless of container size
  • principal manufacturer.

Examples of separate and distinct biologicals (multiple ARTG entries)

Mesenchymal stem cells for treatment of graft-versus-host disease supplied in two different formulations as:

  • 5 × 106 cells in saline
  • 5 × 106 cells in saline with an antibiotic included in the excipient solution.

As these products represent two different formulations, they would be considered separate and distinct goods and need to be included as separate ARTG entries.

In such an example, an application would need to be made for each product, but where part of the dossier supporting the applications is sufficiently similar for their evaluation to be abridged, reduction or waiver of the evaluation fees may apply.

In addition, in some circumstances Class 3 or Class 4 biologicals may be defined as 'separate and distinct' products, but the Secretary may allow certain subsets to be grouped within a single ARTG entry. These specific circumstances will be defined in a gazetted order.

Example of biologicals not separate and distinct (single ARTG entry)

Mesenchymal stem cells for treatment of graft-versus-host disease are packaged into three different doses, but formulation and presentation are otherwise identical:

  • vials containing 1 × 106 cells designed for recipients under 30 kg
  • vials containing 2.5 × 106 cells designed for recipients between 30 kg and 50 kg
  • vials containing 5 × 106 cells designed for recipients over 50 kg.

These three products would be treated as the same biological, provided all other characteristics are the same, and can be included in a single application and included under a single ARTG entry.


Version history
Version Description of change Author Effective date
V1.0 Original publication, using material from the previous ARGB.

Biological Science Section

Regulatory Guidance Team

July 2018