Chapter 1: General Provisions (Articles 1–3)
Chapter 2: Using the System (Articles 4–10)
Chapter 3: Management of the System, etc. (Articles 11–18)
Supplementary Provisions

Article 1. Purpose
The purpose of these Terms of Use is to prescribe necessary matters regarding the use of the Application for Import Confirmation operated by the Ministry of Health, Labour and Welfare.

Article 2. Definitions
The following terms used in these Terms of Use are defined as follows:
(1) "System" means the Application for Import Confirmation for creating application data for application procedures for import confirmation (hereinafter referred to as "Import Confirmation Application") stipulated in Article 56-2 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the "Pharmaceuticals and Medical Devices Act") and for receiving, processing, and reviewing those applications, etc. and issuing Yunyu Kakunin-sho/Import Certificates;
(2) "System User" means a person who files an Import Confirmation Application using the System;
(3) "Administrative Authority" means an administrative authority that conducts reviews, etc. using the System as well as other administrative authorities to which the applicable administrative authority provides information within the purposes deemed appropriate by the applicable administrative authority;
(4) "System Provider" means the Ministry of Health, Labour and Welfare;
(5) "Application Information Screen" means a screen on which a System User confirms information regarding an Import Confirmation Application that the System User has filed;
(6) "Application No." means a number that is assigned when a System User performs procedures, etc. through the System and the System receives the procedural data;
(7) "Login ID (Account ID)" means a code that identifies a System User that is registered by the System User when using the System; and
(8) "Password" means a code that identifies a System User that is registered by the System User when using the System.

Article 3. Application
1. These Terms of Use shall apply to System Users and Administrative Authorities.
2. The System Provider may make changes to these Terms of Use without the consent of System Users or other applicable persons. If these Terms of Use are to be changed, the following information will be notified through the System: the fact that these Terms of Use will be changed, details of changes, and the timing of effectuation.

Article 4. Agreement to These Terms of Use
1. Before using the System, System Users and Administrative Authorities must read carefully and agree to these Terms of Use.
2. The use of the System by a System User or an Administrative Authority is regarded as the System User or the Administrative Authority having agreed to these Terms of Use.

Article 5. System Users
1. System Users shall, at their own risk and discretion, use the System and manage the following information generated in connection with their use of the System as well as any types of messages (including any electronic records) generated at the time of communication, and shall not have the System Provider or any of the Administrative Authorities bear any responsibility or liability whatsoever:
(1) Application No.;
(2) Login ID (Account ID);
(3) Password;
(4) Details of application;
(5) Information displayed on an Application Information Screen;
(6) Any emails and attachment files received in relation to the use of the System; and
(7) Any other information that the System User has created or obtained and is managing in relation to their use of the System.
2. System Users shall comply with these Terms of Use posted on the System as well as other rules relating to the use of the System. Neither the System Provider nor any of the Administrative Authorities shall bear any responsibility or liability whatsoever for any damage that may be suffered by a System User or other third party as a result of the System User not complying with these Terms of Use or any other rules relating to the use of the System.
3. System Users shall, from time to time, check the information relating to applications, etc. made through an Application Information Screen and resolve any errors and/or take other necessary actions. Neither the System Provider nor any of the Administrative Authorities shall bear any responsibility or liability whatsoever for any damage that may be suffered by a System User or other third party as a result of the System User failing to take necessary actions.

Article 6. Administrative Authority
1. Being a national public employee, an Administrative Authority shall strictly comply with the confidentiality obligations set forth in the National Public Service Act when handling information obtained through the System (hereinafter referred to as "Collected Information").
2. If the Collected Information collected from the System contains any personal information, the Administrative Authority shall safeguard such personal information in accordance with the relevant laws and regulations relating to the handling of information held by the Administrative Authority.

Article 7. Intellectual Property Rights Related to the System
1. Any intellectual property rights to any programs and other works related to the System as well as to any know-how, etc. contained in those programs and other works shall belong to the System Provider or the relevant IT service provider.
2. In handling any programs and other works related to the System as well as any know-how, etc. contained in those programs and other works, System Users shall comply with all of the following:
(1) To use them only for the purpose of using the System in accordance with these Terms of Use; and
(2) To not alter, edit, distribute, reverse engineer (disassemble and analyze software, hardware, etc. in order to discover their construction, specifications, purposes, underlying technology, etc.), etc. them.

Article 8. System Operating Hours, etc.
1. As a general rule, System Users may use the System 24 hours a day, 365 days a year; provided, however, that, even within that time band, the use of the System may be suspended without prior notice to System Users due to the maintenance of equipment, etc. If the operation of the System is scheduled to be suspended, it will be notified through the System.
2. Applications, etc. filed by System Users will be processed during the business hours of the respective Administrative Authorities.

Article 9. Format, etc. of Attachment Files
System Users shall make sure that the extension of any attachment files that are used for performing procedures, etc. through the System is doc, docx, xls, xlsx, pdf, png, jpg, jpeg, or zip, and that the size of a single file is not more than 100 MB.

Article 10. Prohibited Acts
The following acts shall be prohibited when using the System:
(1) To use or attempt to use the System for any purpose that is in violation of these Terms of Use;
(2) To use or attempt to use the System for any purpose that is against public policy, such as unauthorized access or sending computer viruses;
(3) To perform any act that is in violation of relevant laws and regulations; or
(4) To perform any other act that obstructs or may obstruct the management and operation of the System.

Article 11. Preparation, etc.
1. System Users shall procure, at their own expense, all the equipment (including any software and telecommunications equipment) that is necessary for using the System. Any procedures necessary for procuring such equipment shall be performed by System Users at their own risk.
2. Any telecommunications costs required for using the System as well as any other costs relating to the use of the System shall be borne by the relevant System User and Administrative Authority.

Article 12. Disclaimer, etc.
1. If the provision of the System is delayed, disrupted, or suspended, neither the System Provider nor any of the Administrative Authorities shall bear any responsibility or liability whatsoever for any damage that may be suffered by a System User or other third party as a result of such delay, disruption, or suspension.
2. The System Provider and the Administrative Authorities may discontinue the provision of the System at any time. If a System User suffers any damage due to the provision of the System having been discontinued, neither the System Provider nor any of the Administrative Authorities shall bear any responsibility or liability whatsoever.

Article 13. Deletion, etc. of Information
If the System Provider determines that the reasonable usage period has expired for any information that a System User or an Administrative Authority has provided to or registered with the System, the System Provider may delete that information. The System Provider shall not bear any responsibility or liability whatsoever for any damage that may be suffered by a System User due to the System Provider having deleted such information.

Article 14. Restrictions on Use in the Case of Emergency or Extremely High Traffic to the System
1. Upon the occurrence of any natural disaster, accident, other emergency situation, serious failure in the System, or other unavoidable event, the System Provider may suspend or restrict the use of the System without prior notice to System Users.
2. If the System experiences extremely high traffic, the System Provider may restrict the use of the System without prior notice to System Users.

Article 15. Failure Management
If the System experiences any failure, System Users, Administrative Authorities, and the System Provider shall take applicable actions as described below:
(1) System Users and Administrative Authorities shall promptly obtain information about the circumstances of the failure and, if necessary, contact the System Provider;
(2) After being contacted by System Users and Administrative Authorities about the occurrence of the failure, the System Provider shall contact the system operation and support provider, etc., make efforts to restore the System promptly, and, as necessary, communicate the state of the restoration work, etc. to the System Users and Administrative Authorities; and
(3) After the System has resumed, the System Provider shall perform an analysis of the failure, make efforts to prevent any occurrence of similar failures, and take necessary remedial steps.

Article 16. Handling of Personal Information
The Administrative Authorities and the System Provider shall properly handle any personal information collected in relation to the use of the System in accordance with this Article of these Terms of Use and the Privacy Policy.

Article 17. Other
Any matters not prescribed in these Terms of Use that are required for the smooth operation of the System shall be notified by the System Provider to System Users and the Administrative Authorities as needed, taking into consideration the opinions of the System Users and the Administrative Authorities.

Article 18. Governing Law and Jurisdiction
1. These Terms of Use shall be governed by and construed in accordance with the laws of Japan.
2. System Users agree that the court of first instance with exclusive jurisdiction shall be the Tokyo District Court for any disputes arising between a System User and an Administrative Authority or the System Provider out of or in connection with these Terms of Use.

These Terms of Use shall come into effect on the operation start date of the System.

1. Basic Principles
The Ministry of Health, Labour and Welfare and the administrative authorities (hereinafter referred to as "Administrative Authorities") that are responsible for affairs relating to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the "Pharmaceuticals and Medical Devices Act") collect information on users who use the Application for Import Confirmation (hereinafter referred to as the "System") operated by the Ministry of Health, Labour and Welfare to the extent necessary for ensuring the smooth and proper implementation of the Pharmaceuticals and Medical Devices Act and the appropriate operation of business by business operators stipulated in the applicable Act.
Any information collected through the System will be properly handled within the purposes of use (hereinafter referred to as the "Purposes of Use") listed under "3. Purposes of Use."

2. Scope of Information to Be Collected
(1) In using the System, users are required to give their basic information (such as name, address, and email address.)
(2) The System collects IP addresses, browsing history, etc., of users as access logs.
(3) Some of the features of the System use cookies to enhance convenience for users and to understand user environments, etc. These cookies do not collect any information that can identify individual users.
(4) The System collects the following information as entered by users on the System:
○ Information relating to import confirmation applications (information relating to Article 56-2 of the Pharmaceuticals and Medical Devices Act, etc.).

3. Purposes of Use
Information collected through the System will be used by the Ministry of Health, Labour and Welfare and the Ministry of Finance, or may be provided to third parties, within the purposes listed below:
a. To conduct a review of an import confirmation application for pharmaceuticals, etc. and handle other administrative affairs;
b. To carry out customs clearance formalities for pharmaceuticals, etc. that have received import confirmation;
c. To ensure that pharmaceuticals, etc. are not imported illegally or illicitly;
d. To investigate cases related to counterfeit medicines or violations of import formalities;
e. To contact System users;
f. To handle inquiries, etc. made by System users and other relevant parties;
g. To enhance convenience in the System and to understand the user environments of System users;
h. To provide information necessary for relevant Administrative Authorities to handle affairs under laws and regulations, etc.; and
i. To help formulate policies in the future.

4. Restrictions on the Scope of Use
(1) Information collected through the System will only be used within the Purposes of Use, except when laws and regulations permit such information to be used by the Ministry of Health, Labour and Welfare or the Ministry of Finance, or to be provided to a third party for purposes other than the Purposes of Use.
(2) Information such as information on access to the System and user attributes may be published after it has been statistically processed.

5. Outsourcing of the Handling of Personal Information, etc.
The handling of any personal information, etc. collected through the System may be outsourced to service providers to the extent necessary. In this case, we will manage and supervise such service providers to ensure that such personal information, etc. will be properly handled.

6. Measures to Ensure Security
Necessary measures will be taken to prevent any leakage, loss, or destruction of collected information and to otherwise manage it properly.

[Contact Us]
Compliance and Narcotics Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare
1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916
+81-3-5253-1111 (Representative)

The System complies with the Web Accessibility Policy of the Ministry of Health, Labour and Welfare (https://www.mhlw.go.jp/accessibility/ ).

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Application for Import Confirmation

(i) Please contact the following for inquiries about the behavior, operation, and specifications of the System. Email：TDEN-aic-helpdesk(at)ml.toshiba.co.jp
*Replace (at) with @.
*The help desk may ask for your registered information, etc. to confirm your status.

(ii) Please contact the appropriate Regional Bureau of Health and Welfare regarding applications and notifications.

-Kanto-Shinetsu Regional Bureau of Health and Welfare
　Email: yakkan(at)mhlw.go.jp
　*Replace (at) with @.

-Kinki Regional Bureau of Health and Welfare
　Email: kiyakuji(at)mhlw.go.jp
　*Replace (at) with @.

Toshiba Digital Engineering Corporation
Kowa Kawasaki Higashiguchi Building, 1-53 Nissin-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-0024

Compliance and Narcotics Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare
Chuo Godo Chosha 5 go-kan, 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916
+81-3-5253-1111 (Representative)