business.gov.au

Japanese Pharmacopoeia - Australian Government

Description

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.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health, Disability and Ageing

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.