You must comply with this Pharmacopeia if you intend to export medicine from Australia into the United States of America (USA).
Prior to the exportation of the medicine you must be able to show:
- the medicine meets the regulatory requirements listed in this Pharmacopeia;
- if the medicine is regulated as a product other than a type of medicine in the USA then it must meet the regulatory requirements for such products; and
- evidence demonstrating the relevant authority in the USA has confirmed its willingness to accept the medicine or confirmed it would have no objection to importing the medicine.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.