Q. My overseas manufacturer meets the requirements for listed medicines what is the next step?

If the products are to be imported and are made by a TGA licenced manufacturer or in a facility with Pharmaceutical GMP in a country with whom the TGA have a mutual recognition agreement you will require GMP Clearance from the TGA.

You will also need the ingredients in your products reviewed for compliance for use in listed medicines.

We can help you to apply for GMP Clearance and undertake ingredient reviews. 

Please contact us for further information.