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