Japanese Pharmacopoeia - Australian Government

Service summary

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;
  • If the medicine is regulated as a product other than a type of medicine in Japan then it must meet the regulatory requirements for such products; and
  • Evidence demonstrating 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.

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Order No. 70C - Standards for Export Only Medicine 2014 (Australian Government)

Contact details

Enquiries
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
TGA, PO Box 100
Woden
Australian Capital Territory 2606

Phone:

1800020653
info@tga.gov.au

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