You must comply with this standard if you are involved in the manufacture of therapeutic or medicinal products that are sold in tablet or capsule form.
Please note that you are exempt from complying with this standard if you are only involved in the manufacture of either:
- medicines intended solely for export from Australia
- radio-pharmaceuticals (pharmaceutical products that contain radioactive substances).
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.