Site notifications

Sub menu

 
 

Understanding your post-market responsibilities for biologicals

Australian Regulatory Guidelines for Biologicals (ARGB)

Guidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).

Published
Last updated

Purpose 

This document outlines the post-market responsibilities for sponsors of biological products included in the Australian Register of Therapeutic Goods (ARTG). This document aims to educate sponsors about their ongoing obligations after their biological products have been approved and registered. 

By providing this information, the document aims to ensure that sponsors understand and comply with their regulatory obligations, thereby maintaining the safety, quality, and efficacy of biological products in the Australian market.

Legislation

Maintaining your ARTG entries

Being the sponsor of an entry in the ARTG, you need to:

Paying your fees & charges

When you have a biological included on the ARTG, you will need to pay an annual charge.

Applications for notification and variation have a fee or fees attached. Sometimes there is both an application and an evaluation fee.

Fees and payments provides an overview and summary of fees and charges for biologicals outlines the fees and annual charges for both manufacturing and sponsoring biologicals.

Manufacturing responsibilities

Following approval of your manufacturing sites, there are a number of ongoing activities that you are responsible for, including maintaining the GMP conditions and accreditation and notifying TGA of any changes to the site or any overseas regulatory action for that site. See Sponsor responsibilities related to GMP clearance and certification.

Biovigilance responsibilities

Biovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other problem related to biologicals.

Biovigilance responsibilities include:

To meet legislated requirements, you need a biovigilance system, which is used to fulfil the tasks and responsibilities associated with the detection, assessment, understanding and prevention of adverse effects of biologicals.

Some additional responsibilities for higher risk biologicals:

Recall responsibilities

As a sponsor of a therapeutic good, you have ongoing responsibilities to ensure you are prepared for a recall and able to respond appropriately to complaints and problem reports. See Roles in recalling therapeutic goods.

Advertising biologicals

Biologicals are not allowed to be advertised to the public. See Australian Regulatory Guidelines for Advertising Therapeutic Goods.
 

Related links

Summary of fees and charges
Sponsor responsibilities related to GMP clearance and certification
Risk management plans for medicines and biologicals
Manage a recall
Topics

Page history

Show all page updates (2)

Title changed from 'Post-market responsibilities (biologicals)' to 'Understanding your post-market responsibilities for biologicals' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Original publication incorporating new legislative changes and information previously published on the TGA website. 

Title changed from 'Post-market responsibilities (biologicals)' to 'Understanding your post-market responsibilities for biologicals' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Original publication incorporating new legislative changes and information previously published on the TGA website. 

Related guidance

Help us improve the Therapeutic Goods Administration site