Listed Medicines are considered low risk medicines and are not required to show pre-market safety data and clinical trials. They are however required to be supported by suitable evidence for the claims that are being made and you are required to hold this evidence prior to listing the product on the Australian register of Therapeutic Goods (ARTG).
Our company can assist with all steps in the listing process. As a guideline for listed medicines the following steps are all the necessary steps in listing of products:
- Review of ingredients for compliance with regulations for listed medicines
- Review or preparation of product specifications
- Preparation of a full list of indications that can be used on your label artwork and in advertising and the evidence packages as per the current evidence guidelines
- Listing company as a sponsors with the TGA
- Preparation and submission of the application for listing
- Preparation of the label draft advising of all of the information needed to appear on the label
- Review of the label artwork prior to print
- Stability protocols and management
- Pharmacovigilance systems and training
We can also assist with:
- Market comparisons
- Product development
- Reformulation to comply with Australian requirements