Qa 2
Qa 2
Qa 2
Q1. Can I bring /send any prescription medicine into Japan from abroad?
A1. You can bring /send any prescription medicine into Japan without any special
procedures on condition that
(1) you bring/send it only for your own use
(2) it is not any prohibited drug in Japan such as Methamphetamine,
(3) it is not any especially controlled drug in Japan such as Narcotics,
(4) quantity is up to one month supply.
(5) it is not permitted to SEND Psychotropic drugs.
Q2. How can I bring more than one month supply of prescription medicine only for
my own use into Japan with me?
A2. You can bring more than one month supply of any prescription medicine, if you
apply for a so-called “Yunyu Kakunin-sho”, a kind of import certificate, and receive it
before you leave home.
Q3. How can I bring any injection and injector only for my own use into Japan with
me?
A3. If you import medicines with syringes for them (permissive self-injection like
insulin) at the same time for less than 1 month supplies, “Yunyu Kakunin-sho” is not
required. (Regarding to efficacy and dosage)
And if you import syringe only (without medicines), you need to apply for “Yunyu
Kakunin-sho” as medical devices even if you import 1 piece
A4. You have to submit the application documents by Email in the PDF format. (If you
don’t have Email address, by post or FAX.
If the Pharmaceutical Inspector can confirm that your application documents are
complete, he/she will send you a “Yunyu Kakunin-sho” by Email in the PDF format.
(If you don’t have Email address, by post)
Q5. What kinds of documents are required in order to apply for a “Yunyu
Kakunin-sho” when I bring medicines with me?
A5.The following documents are required in order to apply for a “Yunyu Kakunin-sho”.
1) Import Confirmation Application Form [FORM 12] (2 copies of this document),
completed the blank application form (See the “Application Forms” attached.)
according to the sample application document. (See the “Application Forms”
attached.)
2) Explanation of Product [FORM 13 for medicines or FORM 14 for products except
medicines], filled in the blank application form (See the “Application Forms”
attached.) according to the sample application document. (See the Application
Forms” attached.) You have to fill out this document for each product.
(Alternative documents such as pamphlets by manufacturers can be accepted, if they
show the descriptions required in Explanation of Product.)
(If you apply for 3 kinds of medicines, you need to fill out 3 "Explanation of
Pharmaceutical Products” forms.)
3) Copy of Prescription or Direction for medicines with a name of the Dr. who
prescribed your medicines, by which the Pharmaceutical Inspector can confirm the
name and the quantity of each medicine only for your own use clearly.
4) Document indicating Arrival Date and Place ( ex. Copy of Airline Ticket or
Flight Itinerary. )
5) Return Envelope (If you can’t send application documents by Email or FAX, you
need send it by post with application.) It’s required with Japanese Postal Stamps and
address where you want to receive a “Yunyu Kakunin-sho”. (“Coupon –Réponse
International” can be accepted instead of Japanese Postal Stamps required, and Return
Envelope needs to have the length 14~23.5 cm and the width 9~12 cm.)
A6.
Place of arrival: Kansai International Airport, Chubu Centrair, Naha Airport, etc.
Kinki Regional Bureau of Health and Welfare
Ooe Building,7th floor, 1-1-22 Nonin Bashi,
Osaka City, Chuo-ku, Osaka Prefecture, JAPAN 540-0011
TEL: +81-6-6942-4096 / FAX:+81-6-6942-2472
Email: [email protected]
A8. After we receive your completed application documents, we normally issue Yunyu
Kakunin-sho in a few business days (not including Saturday, Sunday and National
holidays
A9. If your application documents are not complete, the Pharmaceutical Inspector may
request additional or revised documents.
If you show your fax number or Email address, you can receive his/her request more
rapidly to submit the additional or revised documents.
Please write down your address, fax number or Email address correctly.
Q10. How do I apply for Yunyu Kakunin-sho when I send more than one month
supply of prescription medicine to Japan from abroad?
A10. The required documents and the way to apply for a permit is different from the case
to bring into as below,
At first, you (or your family) send medicines to the place where you are staying in Japan
by postal service (or courier etc/) with the recipient as YOUR NAME.
Then IF you receive notice such as Customs notice (or Air Way Bill etc.) after your
medicines arrive in Japan (which means if your parcel is held at the Customs clearance),
you need to email us (the contact is described on the notice). Then you need to follow
our instruction to receive your medicines.
Then we check the contents of your parcel to the Customs or courier company, and we
will give you guidance whether you need to apply for Yunyu Kakunin-sho or not. If you
need to apply, you have to send the application documents of Yunyu Kakunin-sho to us
by Email, FAX or post.
Required documents for Yunyu Kakunin-sho when you send medicines are as follows,
(It’s different from the case of bringing.)
1) Import Confirmation Application Form [FORM 12] (with your signature, and
needed 2 copies only as to this document), filled in the blank application form (See
the “Application Forms” attached.) according to the sample application document.
(See the “Application Forms” attached.)
2) Explanation of Product [FORM 13 for medicines or FORM 14 for products except
medicines], filled in the blank application form (See the “Application Forms”
attached.) according to the sample application document. (See the Application
Forms” attached.) You have to fill out this document for each product.
(Alternative documents such as pamphlets by manufacturers can be accepted, if they
show the descriptions required in Explanation of Product.)
(If you apply for 3 kinds of medicines, you need to fill out 3 "Explanation of
Pharmaceutical Products” forms.)
3) Copy of Prescription or Direction for medicines with a name of the Dr. who
prescribed your medicines, by which the Pharmaceutical Inspector can confirm the
name of each medicine only for your own use clearly.
4) A copy of Invoice (if you have)
5) A copy of the postcard from a customhouse (with Notice number) (if by Air)
Or A copy of the bill of lading(B/L)(if by Ship)
Q11. What shall I do, if I have further questions regarding medicines which I am
bringing/sending into Japan with me, or if I have little time before I leave home?
A11. Please contact any Pharmaceutical Inspector in your place of arrival’s neighboring
office by Email with the information including the name of International Airport (Place
of Arrival), the product name of your medicines, the name and the amount of active
ingredients (ex: XXmg / tablet etc.), figuration of medicines (“vial” or “tablets” etc.),
the amount of medicines which you bring (“XXmonth supply” or XXtablets”etc.)
Place of arrival: Kansai International Airport, Chubu Centrair, Naha Airport, etc.
・ Kinki Regional Bureau of Health and Welfare
TEL: +81-6-6942-4096 / FAX:+81-6-6942-2472
Email: [email protected]
〔様式 12〕 [FORM 12]
誓約事項 □ The import products above are solely for the purpose of import above, not for commercial
(Oath) use and /or gift for others.
確認事項 □Within the past two years, I have not violated the laws and regulations related to
(Confirmation matter) pharmaceutical affairs stipulated by Cabinet Order or the disposition based thereon.
輸入しようとする品目の製造業者名及び国名 (Name of manufacturer and Country Origin of Import Products)
輸 入 年 月 日 船荷証券、航空運送状等の番号 到着空港、到着港又は蔵置場所
(Import Date / Arrival
(AWB No., B/L No. or Flight No.) (Arrival Place (Airport, port or Storage place))
Date)
/ /
(Year) (Month) (Date)
備 (Note)
考
(For Official Use) 特記事項
確
認
欄 厚生労働大臣(地方厚生局長) ㊞
/ /
(Year) (Month) (Date)
Name of Importer
Importer’s Signature
Address of Importer
Phone Number
E-mail @
商 品 名
(Name of product)
具 体 的 な 用 途
(効能・効果、用法)
(Efficacy, Dosage)
規 格
(Specifications)
〔様式 14〕[FORM 14]
商 品 説 明 書 (Explanation of Product)
商 品 名
(Name of product)
化 学 名 、 一 般的
名称又は本質
(Chemical Name or
Active Ingredients Name)
用 途
(効能・効果)
(Efficacy)
規 格
(Specifications)
(Sample)
〔様式 12〕 [FORM 12] e.g. Medicine, Medical Device, Cosmetics etc.
備 (Note) If you are sending medication or are having medication sent to you by post, you
考 must include the AWB No. or the B/L No.
2020 / Jun / 1
(Year) (Month) (Date)
Name of Importer KANTO SHIN-ETSU
商 品 名
Aspirin tablet 200mg
(Name of product)
規 格
Aspirin tablets cases in a box aluminum laminate 10 tablets.
(Specifications)
(Sample)
商 品 説 明 書 (Explanation of Product)
化 学 名 、 一 般的
・K-PAP Machine
名称又は本質
・K-PAP Mask ( For replacement )
(Chemical Name or
・Tube( For replacement)
Active Ingredients Name)
用 途
(効能・効果) Treatment for sleep apnea syndrome
(Efficacy)
・K-PAP Machine
Model; XXX
規 格 ・K-PAP Mask
(Specifications) Size; XXX
・Tube
Size; Taper:XX. Length:XX