Understanding your post-market responsibilities for biologicals
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).
Recently published
This page was published on [date_placeholder].
Recently updated
This page was updated on [date_placeholder]. See page history for details.
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.
Maintaining your ARTG entries
Being the sponsor of an entry in the ARTG, you need to:
- continue to satisfy the conditions that were part of the approval for inclusion on the ARTG
- provide information to us about your product, if requested
- notify us of notifiable changes
- request a variation, when applicable You may also want to:
- reinstate an entry on the ARTG
- change the sponsor of therapeutic goods.
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:
- a Risk Management Plan (RMP) is required for Class 3 and 4 biologicals
- a Periodic Safety Update Report (PSUR) is required for Class 3 and 4 biologicals and when imposed for a particular Class 2 biological.
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.
Page history
Original publication incorporating new legislative changes and information previously published on the TGA website.
Original publication incorporating new legislative changes and information previously published on the TGA website.