PUI - Guide for PLM Portal Product User Interface Navigation

With a PUI User or Qualified User role, you can access the PLM portal and manage PMS data for your organisation.
To access the PLM Portal – Product User Interface (PUI) all users are required to have:

• an active EMA user account, and,
• user access role(s) assigned to that account.

For information on how to request an EMA account and how request an appropriate PLM Portal - PUI role (these are two separate actions), please consult the separate PUI - Registration Guide.
Please visit the EMA Account Management page to login (or create an account first and request a PUI role.
PUI roles and permissions are explained in the PUI - Registration Guide. PUI roles are currently only available to participants in the PUI pilot.
Registration needs to be done only once.

The PLM Portal - PUI can be accessed on any modern Web Browser, including but has only been tested with Google Chrome (latest version) and Edge (including the new, Chromium-based Edge). No official testing has been done using other browsers, such as Safari 12 and above, Firefox (latest version), Vivaldi, etc.

A PUI Industry User/ Qualified User will only see authorised PMS medicinal products owned by the relevant MAH.
Please refer to 'Grants provided by user access roles' in the PUI - Registration Guide.
For further information related to the accessibility of PMS data by NCA User/Qualifier Users please refer to EU IG Chapter 5 and relevant Annex A.

To access PLM Portal – PUI the user is required to log in with their PUI username and credentials gathered prior registration to PLM PUI portal via IAM account. 

To navigate across PLM Portal – PUI, users can use the following areas:

• Product Management Service
• SPOR
• Owned Products

Upon successful login user can access the following:

• PMS authorised product data s/he does own.

This can be achieved in two ways:

1. by clicking in the section named “Product(s) under my Organisation (s)” under the “Product Data Management” are OR
2. by clocking in the section named “Owned Products”

Both links are available in the home page.

Access to the products they own for their respective organisation based on the access level there are assigned to. For further information about the access levels please refer to EU IG Chapter 5 and related Annex A.

• Limited set of PMS authorised public product data s/he does not own.

This can be achieved by clicking in the section named “Medicinal Products” under the SPOR area available either in the home page or in any other navigation pages. For further information about the access levels please refer to Annex A of EU IG chapter 5.


User might be requested to re-login after 10 hours of inactivity.

To search products data user can use the “Search” functionality available at the bottom of the screen to the left side. In case a new search is needed the user should use the “Reset” button.

The result of the search will be displayed under the blue bar to the right side of the screen.

The total number of records obtained from the search is reported at the bottom to the left side.

User can navigate across the pages and results by clicking on the page numbers.

Alternatively, users can use the “Previous” or “Next” button available to the right side at the bottom of the page.

The number of items to be displayed in each page can also be set up by the user by selecting 10, 25 or 50 rows under the “Show” button available on the top of the blue bar.

To search products data user can query the system by using the filters available to the left of the “Product(s) of my Organisation(s)” area. Users can refine the searching via applying the following filters:

• PMS ID
• Full medicinal product name
• Authorised Dose Form
• Marketing Authorisation Holder (MAH name)
• Marketing Authorisation Number
• Active Substance
• Authorisation Country
• Authorisation Status
• MRP / DCP / CP Nr.

User can enter multiple values and use RMS related terms (i.e. Authorised Dose Form, Authorisation Country, Authorisation Status) when applicable to launch the search.

In addition to the search functionalities and applicable filters reported in the section Search PMS Data, user can further refine the result of their search by applying additional filters available in the drop-down menu under the “Column visibility” above the blue bar. As result of this selection, user will be able to see under the blue bar the results of the launched search further filtered.

Users have two options to export/download product data resulting from research:

• Use the “Download” functionality available above the blue bar. This functionality is usable for the general research and within the selected Medicinal Product record;
• Use the “Export to XML” functionality to export the product data from specific sections available within the Medicinal Product record selected. To use this functionality, users must select the Medicinal Product and click on the “View Data” button and read and accept the condition reported in the Data Protection Disclaimer message.

The result of the above functionality will generate the following files:

• “Download” triggers the creation of an excel file.
• “Export to XML” triggers the creation of an XML file.

This page is an entry point for Processes/edit pages. However, the Manage Product Data button will be removed in the Production environment as this functionality will be embedded in the search page. 

This page supports the navigation across the Power BI reports to facilitate product data analysis and profiling activities. This page is accessible to PMS PUI roles (EMA, Industry and Network).

Please note that this section does not apply for the purpose of the PUI UAT. 

During the PUI UAT testers can receive support from PUI team members and attend the UAT check points scheduled.

The Service Desk
For technical support with the PLM Portal, please use directly the PLM Portal-PUI section of the EMA Service Desk portal. This includes issues related to creation of new accounts, access to existing accounts, accessing data and performance of PUI database. 
If you have a user account for a system hosted by EMA, you should use the same username and password for this service. Otherwise, please Sign up for a new account or reset your login credentials.
The Service Desk portal is optimised for use with Chrome, Edge, Firefox or Safari web browsers. If you encounter problems, please use one of these browsers instead.
 

• Report an issue with the PLM Portal - PUI, to create a ticket for the issue you are experiencing;

   Request information about the PLM Portal - PUI , to create a ticket for the question you may have.
Depending on the issue or question, you can select from different problem areas:

• PLM portal – PUI General (topics covering multiple aspects and/or general nature)
• PLM portal – Product Data (issues and questions with the product data as exposed/published in PUI)
• PLM portal – PUI access (issues and questions on the access to PUI)
• PLM portal – PUI functionalities (issues/discrepancies/errors with capabilities i.e. filtering, exporting, sorting, searching etc.)

Please provide a clear description of the issue and provide screenshots or any supporting document as attachment as these can help to solve the query a lot faster.
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The PLM Chatbot 
  The PLM Chatbot is an artificial intelligence tool where users are offered with digital assistance for commonly asked questions in an interactive mode. You are encouraged to use the buttons to navigate through the information or to type your question directly into the chat.
To access and engage with the PLM Chatbot, click on the icon, available on the right-hand side of the PLM Portal.