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.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.