Sunday, July 24, 2011


 0. 結論

Personal Importation Scheme での輸入(郵送)場合、処方箋を書くのがオーストラリアの登録医である必要あり。


1. 持ち込み

1.1. Medicare Australia - Bringing medicine into Australia

医薬品の持ち込みにあたっては Department of Health, The Australian Customs Service, The Australian Quarantine and Inspection Service が関係部署で、それぞれに確認が必要。

1.2. OCSEH - General Guidance for travellers bringing medicines to and from Australia

旅行者、個人輸入については、OCSEH と TGA の特例も規制の対象となる

1.3. TGA - Entering Australia, Travelling with medicines or medical devices into Australia

Traveler's exemption, または Personal Importation Scheme で医薬品を持ち込める。
Traveler's exemption -> 持ち込み、Personal Importation Scheme -> 郵送、なのかな?

1.4. TGA - Personal Importation Scheme

"Personal Importation Scheme

Under the Personal Importation Scheme you may import a 3 month supply (at the maximum dose recommended by the manufacturer) of unapproved therapeutic goods into Australia in any one importation without any approval required by the TGA provided that:

    * the goods are for your own treatment or the treatment of your immediate family; and
    * you do not supply (sell or give) the medicine to any other person; and
    * where possible, you keep the medicines or medical devices in their original packaging with any dispensing labels intact; and
    * the goods are not restricted under Australian Customs controls or quarantine rules and the goods do not contain a controlled substance (see: Import & export of controlled substances); and
    * the goods are not injections that contain material of human or animal origin (except insulin); and
    * the total quantity of the goods imported within a 12 month period does not exceed 15 months supply of the goods (for medicines, at the maximum dose recommended by the manufacturer); and
    * if the goods are medicines in Schedule 4 or 8 of the Poisons Standard a prescription from a registered medical practitioner is held for the medicines."

1.5. OCSEH - List of drug substances requiring import and or export authorisations

上記 Import & export of controlled substances のリンク先
Mesalazine は対象外、よって Import Authorization 不要。

1.6. TGA - The Poison Standard

1.7. TGA - Poisons Standard - F2010L02386

Mesalazine が Schedule 4 に入ってる。よって Personal Importation Scheme の要求事項である Registered medical practitioner 処方箋が必要。"Registerd medical practitioner" の定義がハッキリとしないが、Webの実例を確認する限り日本のドクターが作成した英語の処方箋 or処方箋+英訳でOKな模様。

Schedule 4 の定義
"Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription."

1.8. TGA - Substances subject to import controls

TGA としての規制対象の薬(成分)
Mesalazine は規制対象外。

1.9. Australian Customs and Border Protection Service - Prohibited and restricted imports

Australian Customs and Border Protection Service としての規制対象の薬(成分)
Mesalazine は規制対象外。

1.10. 在日オーストラリア大使館 - 関税部 医薬品の持ち込み(参考)

1.11. Australian Quarantine and Inspection Service - Importing Therapeutic Substances, Foods and Dietary Supplements
"In general, any synthetic substances - that is, completely man-made substances such as aspirin - are not a quarantine concern. Sufficient documentation should be available to prove the synthetic nature of the material."
Mesalazine は synthetic substances、よって検疫関連については申請不要。

1.12. ケアンズぷらす - オーストラリアへの薬の持ち込みとイオン飲料

制度的には、上記 Traveler's exemption で持ち込んでることになる。

2. 郵送

2.1. OCSEH - General Guidance for travellers bringing medicines to and from Australia

"What happens if my medication runs out while I am visiting Australia?
Therapeutic goods that are not prohibited imports, are not injectables of human or animal origin, and in the case of prescription medicines are the subject of a prescription by an Australian registered doctor, may be personally imported for the personal use of the importer or a member of the importer’s immediate family in certain quantities. Further information is available form the Therapeutic Goods Administration in relation to personal importation under the Therapeutic Goods Regulations 1990."

Australian registered doctor の処方箋が必要。

2.2. Australian Customs and Border Protection Service - Importing Goods by Post

送付対象の価値が A$1,000 以下であること、超えるとGSTの課税対象

2.3. オーストラリアでのペンタサの値段

1日 3g の処方で A$297.44/月、3ヶ月分の処方でも A$1,000 未満、よってGSTの対象外。

2.4. Australian Customs and Border Protection Service - Prohibited and restricted imports


2.5. 在日 オーストラリア大使館 - 国際郵便に関する重要な検疫情報(参考)

2.6. 日本郵便 - オーストラリアへの内服薬及び外用薬の送付

"内服薬及び外用薬は、名あて国の保健局長(Director General of Health)の許可 を得ている場合に限り許される。"
なにこれ?少なくとも、Mesalazine の場合は Import Authorization を得る必要はない。

2.7. 日本郵便 - オーストラリアへの非伝染性物質、医薬品等
少なくとも、Mesalazine は Custom, Quarantine 的にOK で、Import Authorization を得る必要なし。Personal Importation Scheme で要求される処方箋(英語のもの)さえ用意すればOK、ということかな。

3. 備考
OCSEH: Australian Government Department of Health and Aging Office of Chemical Safety and Environmental Health
TGA: Australian Government Department of Health and Aging Therapeutic Goods Administration

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