The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Sponsors may need to update certain product details included in the Australian register for therapeutic goods (ARTG) for their non-prescription medicine.
Some examples of changes include formulation changes, changes to indications and changes to manufacturer details.
Listed and assessed listed medicines (including sunscreens)
Minor changes to listed medicines on the ARTG (other than those listed for export only) are made via the TGA Business Services (TBS) system.
For further information, including the types of changes that incur a fee, refer to the document: Guidance on product changes in ELF 3. ELF refers to Electronic Listing Facility and is an area within TBS.
See also:
- How to remove indications and add permitted indications for your existing medicine
- Changing a listed or assessed listed medicine: application levels and change tables
Changes may create a separate and distinct good
Where the intended change does not create a 'separate and distinct' good - Section 16 (1A) of the Act outlines the criteria which make listed medicines (other than those listed for export only) 'separate and distinct' goods - there are provisions in the legislation for certain details to be amended on a medicine's ARTG entry, upon request by the sponsor, and maintain the same AUST L number.
If the intended change to the listed medicine creates a good that is considered to be separate and distinct from the existing good, sponsors are required to submit a new application to list the goods and a new AUST L number will be issued (unless the medicine is eligible for 'grouping' under the existing AUST L number - see Therapeutic Goods (Groups) Orders.
Registered non-prescription medicines
The process for varying an Australian Register of Therapeutic Goods (ARTG) entry for registered complementary medicines and over the counter medicines (OTC) is similar.
Applications to change an ARTG entry for a registered complementary medicine (RCM) are categorised into five levels (CN and RCM C1 to C4) based on increasing complexity.
Applications in lower levels require less supporting information, have lower fees and reduced timeframes compared to applications in higher levels. It is important that you select the correct change codes from the RCM changes tables as these will determine the application level for you. See: Changing a registered complementary medicine RCM: application levels and changes tables
Most changes to an ARTG entry for a registered over the counter medicine require our approval prior to making the change to the medicine.
To determine whether your change requires prior approval check changes code tables. See: Changing an OTC medicine: using the Changes Tables
If your change is identified as:
- 'SRR', 'SAR', 'N' or 'A', you will need to apply for approval prior to making the change to the medicine.
- 'New'. Go to OTC medicines registration process as you will need to apply for a new ARTG entry.
- 'O', you do not need to apply for approval to make the change.