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.
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.
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.
More information
- Registered medicine variation form (complementary medicines)
- Process to change a registered OTC medicine
- Changing a registered complementary medicine RCM: application levels and changes tables
- Changing an OTC medicine: using the Changes Tables
- Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected