Responsibilities of Australian sponsors of medicines for Aust L Products
Entering a product on the ARTG
To submit an application to include a product in the ARTG and obtain an AUST L number goods must meet the requirements for listed medicines.
Follow the steps below in preparation to submit an application to the ARTG.
Step 1:
Permissible Ingredients
Listed medicines may only contain certain low risk ingredients permitted for use.
All ingredients and substances that may be used in Listed medicines in Australia must be on the list of approved permitted ingredients (Permissible Ingredients).
For guidance on the process for a substance to be evaluated for use as a new ingredient in listed medicines please see below link.
Step 2:
Good Manufacturing Practice (GMP)
Listed medicines must be manufactured in accordance with Good Manufacturing Practice (GMP) in a TGA approved facility.
Sponsors must ensure that the manufacturer has a licence or clearance
for the mandatory steps in manufacturing:
- Manufacture of dosage form
- Packaging & labelling
- Release for supply
- Microbial and chemical Testing
Step 3:
Permissible Indications
Listed medicines must only use indications drawn exclusively from a list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines.
Only specified permissible indications must be used in relation to the Permissible Ingredients when contained in a medicine.
You can find these in the Permissible Indications Determination.
Step 4
Evidence to support the indications and claims
Depending on the type of medicine, Aust L, Aust L(A) or Aust R, the following documents may be required:
- Evidence package cover page
- Evidence search strategy results
- Evidence of traditional use filter
- Scientific evidence filter
- Evidence of traditional use summary
- Evidence summary for scientific indications
- Pre-market efficacy assessment
- Ingredients from a list of pre-approved ingredients only or ingredients are assessed pre-market
- Indications (conditions the medicine says it will treat) from a list of pre-approved conditions only or conditions are assessed pre-market
- Post-market compliance reviews
- Post market surveillance
Step 5
Labelling requirements and Advertising Code.
Legislation mandates what can and cannot be displayed on the label.
The overall presentation of your label, including any graphics, claims or indications will also need to comply with the Therapeutic Good Advertising Code.
The permissible ingredients and permitted indications selected for use may also have requirements for advisory statements to be included on your label.
Other legislative requirements:
All therapeutic goods must conform to any applicable standards before they can be entered on the ARTG. The standards recognised under the Therapeutic Goods Act 1989 (the Act) are the default standards and the Therapeutic Goods Orders (TGOs).
Step 6
Post-market Activities
Once a product has been included in the ARTG, it must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.
These activities are considered Post Market Activities, The TGA has mandatory requirements for these ongoing responsibilities. All manufacturers and sponsors of products must maintain and conduct the following activities:
- Comply with the Sponsor's and Manufacturer's ongoing responsibilities
- Conduct Stability/ shelf-life studies and report
- Post market reviews
- Pharmacovigilance:
• SOP Suspected Adverse Reactions
• SOP Significant safety issues
• SOP Handling Product Complaints
• SOP Recall coordinators