To sell medicines in Australia (Listed, OTC or Registered) the manufacturer must have GMP (Good Manufacturing Practice) that is acceptable to the TGA (Therapeutic Goods Administration). To satisfy the TGA the manufacturer can be audited by the TGA, use the Mutual Recognition Agreement (MRA) GMP clearance pathway or use the CV GMP clearance pathway.

The MRA is an agreement between Australia and certain countries where Australia recognises the GMP provided by the Regulatory Authority of overseas countries were the inspection has occurred within its own borders. This is very similar to having a TGA GMP certificate.

The CV GMP clearance pathway is where other regulatory authorities regulate GMP for medicinal products and are a PIC/s participating authority. A list of participating authorities can be found here.

THE CV GMP Pathway requires the manufacturer to provide the following documentation.

The TGA provides detailed advice in there GMP Clearance Guidelines.