Manufacturing medicines

This section is for the manufacture of medicines. You should also see Manufacturing basics and Manufacturing inspections, which include information for manufacturing of all types of therapeutic goods.

For blood, blood components and HPCs go to Manufacturing blood and blood components.

The Good Manufacturing Practice application decision tree can help you in determining if GMP licencing, certification or clearance is required.

Licence and GMP certification

Licence and overseas GMP certification applications

Revoking manufacturing licences

GMP clearance

 

 

 

 

Legislation & codes of practice

Section 36 of the Therapeutic Goods Act 1989 allows the Minister for Health to determine Manufacturing Principles that are to be applied in the manufacture of therapeutic goods.

GMP guidance

The TGA has developed specific guidance for certain types of medicines. These offer pragmatic guidance on how compliance with GMP principles may be achieved.

GMP guidance for all medicines

Sterile medicines

Listed complementary medicine GMP guidance

Specific medicines