While the consultation is open you can make a submission at our consultation hub.
After the closing date, the submissions will be reviewed, and our decision will be published on the same consultation page.
About this consultation
Medicines listed in the Australian Register of Therapeutic Goods (ARTG) under section 26A of the Therapeutic Goods Act 1989 (the Act) are included in the ARTG without pre-market assessment by the Therapeutic Goods Administration (TGA). These medicines are self-listed by the applicant (who becomes the sponsor), or an authorised representative on behalf of a sponsor (such as a regulatory affairs agent) through the TGA Business Services (TBS) system.
Once listed, section 9D of the Act permits sponsors to request the Secretary’s approval to vary (change) certain information in the ARTG entry for their medicine, provided, in general, that the proposed variation would not make the new entry ‘separate and distinct’ from the existing ARTG entry.
In most circumstances, decisions on proposed variations for listed medicines are made by the TBS system via an Automated Decision Making (ADM) process [namely, decisions made under section 9D of the Act excluding subsection 9D(1)]. The TBS system also determines via an ADM process where a proposed change to an existing listed medicine requires a new listing to be created under s 23 of the Act.
This consultation identifies legislative provisions, definitions and guidance that are not clear or transparent in relation to variations and other changes that can be made for listed medicines. The TGA is seeking feedback on proposed approaches to provide greater transparency and certainty regarding automated decision-making in relation to proposed variations (and other changes) for listed medicines.
The specific matters under consideration include clarifying the following:
- guidance for changing the information about listed medicines in the ARTG
- the legislative basis for variation decisions subject to ADM
- the term ‘restricted ingredient’ and its scope concerning permitted ingredients in relation to when changes to a listed medicine would be considered to create a separate and distinct entry in the ARTG.
The TGA is requesting feedback to help ensure there is clarity, transparency and certainty regarding automated decision-making, and more broadly, the regulatory pathways, relating to applications to change information about listed medicines in the ARTG.