You must comply with this Pharmacopoeia if you intend to export medicine from Australia into Japan.
Prior to the exportation of the medicine you must be able to show:
- the medicine meets the regulatory requirements listed in this Pharmacopoeia
- whether the medicine is regulated as a product other than a type of medicine in Japan and that it meets the regulatory requirements for such products
- evidence demonstrating that the relevant authority in Japan has confirmed its willingness to accept the medicine or confirmed it would have no objection to importing the medicine.