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Information regarding Newly Introduced Electronic Package Inserts

Information regarding Newly Introduced Electronic Package Inserts

Following the amendment of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act), paper-based package inserts that used to be enclosed with products are abolished in principle from August 2021*. Basically, package inserts should be browsed in an electronic way. This page introduces how the electronic package inserts are browsed, and its detailed systems and specifications. The information on this page is current as of 2021 and will be updated in the future.

*For products that consumers purchase directly, such as OTC drugs, the paper package inserts will continue to be enclosed.

<To the Marketing Authorization Holders>

In particular, for medical devices and in vitro diagnostics, posting the package inserts on the website, which had not been required, is now mandatory. Please refer to the following notice for more information  (only in Japanese). For more information on items subject to electronic package inserts, please refer to the following notifications, etc. issued by the Ministry of Health, Labor and Welfare "Provision of Information on Precautions, etc. for Drugs, etc.” (PSEHB/PSD Notification No. 0219-1, February 19, 2021)
Marketing Authorization Holders (MAHs) must register the information on the Safety Information Posting System located on the PMDA's website for MAHs. For information on how to register medical devices in the system and post the electronic package inserts, please refer to this information (only in Japanese) .

Note: Contents of the electronic package inserts and the whole system for browsing such information including the app are available only in Japanese.

How to Browse the Electronic Package Inserts (only in Japanese)

Following the amendment of the PMDA Act (Effective on August 1, 2021), an application (app) is available on smartphones, etc. to read the code (barcode or two-dimensional code) on the outer box of a product for direct access to package inserts, etc. This makes it possible to always use the latest information to implement safety measures. From the barcode attached to the box, it is possible to view not only the electronic package inserts, but also related documents such as review reports. Please refer to the following figures.

Note: Contents of the electronic package inserts and the whole system for browsing such information including the app are available only in Japanese.

How to Browse the Electronic Package Inserts

Related Documents to be Displayed
Item Related documents to be displayed
Prescription drug products
(for healthcare professionals)
Electronic package inserts, drug guide for patients/guide for vaccinations,   drug interview forms, Risk Management Plan (RMP), RMP materials, revision history of PRECAUTIONS and case summary that served as the basis for the revisions, review report/re-examination report/Optimal Clinical Use Guidelines, etc.
Prescription drug products
(for general consumers)
Drug guide for patients/guide for vaccinations, Drug information sheet, RMP materials (for patients), manuals for management of individual serious adverse drug reactions (ADRs)
Medical devices Electronic package inserts, revision history of PRECAUTIONS, review report/re-examination report, Yellow Letters ( Dear Healthcare Professional Letters)
In vitro diagnostics Electronic package inserts, Yellow Letters (Dear Healthcare Professional Letters), Blue Letters, Alert for Proper Use of Drugs
Cellular and
Tissue-based Products
Electronic package inserts, review report/summaries of product applications/Optimal Clinical Use Guidelines, etc., Yellow Letters (Dear Healthcare Professional Letters), Blue Letters
 

Applications to Read the Code on the Containers of Drugs, etc.

 PI (Package Insert)-navi (Information is available only in Japanese.)

 < Developer >
The Distribution System Research Institute (GS1 Japan), the Federation of Pharmaceutical Manufacturers' Associations of JAPAN (FPMAJ), the Japan Federation of Medical Devices Associations (JFMDA)

 < Download >

The app can be downloaded from the following  official stores.
  App store
  Google play

 < Website >

 < Related Materials >

  Leaflet (brief version)
  Leaflet (detailed version)
  Videos

< References >
Administrative notice “Regarding applications for smartphones, etc. that allow users to browse the PMDA's website , which contains information on precautions, by reading the codes on the containers of drugs, etc.” dated May 10, 2021
  Technical Information on the Link between the Code on the Outer Box and the Corresponding Webpage
Please refer to the following information on how to access the electronic package inserts from the code on the outer box.

Notifications, etc. Related to Safety Measures such as Revisions of Package Inserts

Classifications Date Title Japanese
Drugs September 27, 2021
Administrative Notice

Notice concerning "Standard Workflow for Consideration of Safety Measures such as Revision of Electronic Drug Product Package"

Reference: Standard Workflow for Consideration of Safety Measures



Drugs / Medical Devices / Cellular and Tissue based products / In vitro Diagnostics Administrative Notice

June 11, 2021 (1st Amendment)

July 14, 2021 (2nd Amendment)
Questions and Answers (Qs and As) regarding “Provision of Information on Precautions for Drugs, etc.”

Attachment : The original Japanese version was established on February 19 and revised on June 11 and July 14, 2021. The English version includes these corrections.




Medical devices May 14, 2021
Administrative Notice
Points to Consider for Consultations Associated with Revision of Descriptions in Package Inserts, etc. of Medical Devices
Drugs / Medical Devices / Cellular and Tissue based products / In vitro Diagnostics February 19, 2021
PSEHB/PSD 0219 No.1
Provision of Information on Precautions, etc. for Drugs, etc.

 

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