Site notifications

Sub menu

 

 

Manufacturing for medicines

Understand our Good Manufacturing Practice regulations that apply to medicines. 

You must comply with regulatory requirements when manufacturing medicines.   

 

Medicines must be manufactured in accordance with legislated Good Manufacturing Practice (GMP) standards to ensure their quality, safety and efficacy.  

 

We regulate these activities to protect public health and ensure medicines remain safe and effective.  

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. You may also have to meet obligations that apply to all products.

Good Manufacturing Practice

Understand the standards for Good Manufacturing Practice.

GMP clearance

Access information on applying for GMP clearance.

Licensing

Find out how to apply for, vary or maintain a manufacturing licence.

Certification

Access information on applying for or varying certification.

Inspections

Learn how TGA conducts inspections of manufacturing sites.

Product types