Purpose and Context
- "Dynamic product report" section update: Text updated (updates highlighted in yellow) and screenshots updated
- "Human medicinal product overview public report" section addition
Preliminary requirements
With a PMS PUI User or Qualified User role, you can access the PLM portal and manage PMS data for your organisation.
To access the PMS 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 how to request an EMA account and how request an appropriate PMS PUI role (these are two separate actions), please consult the separate PMS Product UI - Registration Guide.
Please visit the EMA Account Management page to create an account and request a PMS PUI role(s).
PMS PUI roles and permissions are explained in the PMS Product UI - Registration Guide.
Registration needs to be done only once.
Supported browsers
The PMS PUI can be accessed on any modern Web Browser, however it has only been tested with Google Chrome (latest version) and Edge (including the new, Chromium-based Edge). No official testing has been performed using other browsers, such as Safari 12 and above, Firefox (latest version), Vivaldi, etc.
Visibility of products in PMS PUI
A PUI Industry User or Qualified User can only see authorised PMS medicinal products owned by the relevant MAH.
For further information related to the accessibility of PMS data by NCA User or Qualifier Users please refer to EU IG Chapter 5 and relevant Annex A.
To request the PUI role(s) please refer to 'Grants provided by user access roles' in the PMS Product UI - Registration Guide.
Access PMS PUI
To access PMS PUI the user is required to log in with their PUI username and credentials gathered prior registration to PMS PUI portal via IAM account.
User might be requested to re-login after 10 hours of inactivity.
Navigation through the PMS PUI
To navigate across PMS PUI and access the relevant product data, users can use the following areas:
- Product Management Service
- SPOR
- Owned Products
Upon successful login user can access the following:
- PMS authorised product data owned by the user. This can be achieved in two ways:
- by clicking in the section named “Product(s) under my Organisation (s)” under the “Product Data Management” area OR
- by clicking in the section named “Owned Products”
Both links are available in the home page.
The initial search screen of PUI opens.
- Limited set of PMS authorised public product data owned by the user.
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 can go back to the home screen by clicking on the Product Lifecycle portal logo.
Search PMS data
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.
Only the first entries of the search result are shown, however users can load more results by clicking on the "Load more" button".
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 “Load” button available on the top of the blue bar.
Filtering PMS data
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 Name
- Authorised Dose Form
- Marketing Authorisation Holder (MAH name)
- Marketing Authorisation Number (MA Nr.)
- Active Substance
- Authorisation Country
- Authorisation Status
- MRP / DCP / CP Nr.
In some fields the user can enter multiple values and RMS related terms must be used (i.e. Authorised Dose Form, Authorisation Country, Authorisation Status) when applicable to launch the search.
Fields like Full name and PMS ID can be populated with one value at the time.
When looking for RMS terms within the searching criteria, please note that the results are in alphabetical order. User is required to scroll over the results displayed in the drop-down menu to select the controlled vocabulary terms is looking for.
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 previously launched search further filtered.
Users are recommended to work with multiple tabs in parallel to not lose search results.
Export/ Download PMS data
Users have two options to export/download product data resulting from research:
- Use the “Download” functionality available above the blue bar. This functionality is used for the general research and within the selected Medicinal Product record. It provides the overview list of products as displayed. The results generate an Excel file containing the previously loaded records from the searching area. In case the user aims to access the whole data set, it is recommended not to use this functionality but to use the Dynamic Product Reports.
- Use the “Export to XML” functionality to export the product data from specific sections available within the Medicinal Product record selected. This functionality provides the full data set for the selected product(s) in detail. To use it, users must select the Medicinal Product, click on the “View Data” and then “Export to XML” buttons, 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.
Dynamic product report
This page supports the navigation across the Power BI reports to facilitate product data analysis and profiling activities. This page is accessible to registered PMS PUI users (EMA, Industry and Network). The level of accessibility to product data depends on the type of PMS PUI role the user is using to access the portal. For further information related to the PMS access levels please refer to EU IG Chapter 5.
Under this section, the user will access a series of Reports as reported below:
- Product(s) of my organisation(s)
- Manufacturing operations
- All Ingredient
- All packages
- All ATC codes
In each of the available report pages filters can be applied as needed. This functionality is available to the right side of the reports page and can be expanded or hidden upon need.
In case of high number of products, user can further refine the result displayed in the relevant report pages to focus on a specific subset of products of interest.
Product(s) of my organisation(s) report
This dynamic report type allows the user to have an overview of all products owned.
User can access three sub report types:
- Product Visualisation
- Medicinal product by MAH
- Product(s) of my Organisation.
In the first Product Visualisation report type data are classified by:
- MAH
- Authorisation status
- Country
- Active Substance
- Dose Form
- Procedure Type
Each of the above classification provides data in a table. User can therefore dynamically move from one table to another based on the selected values of interests. The result of the selection will generate an update of all the tables.
Before selecting the dose form “tablet” number of centrally authorized medicinal product is 4633 (equal to 100%).
After the selection of the dose form “tablet” the number of centrally authorised medicinal products shows 278 as value (equal to 6% of the totally CAPs products) while the rest of the dose form tabs become pastel-coloured.
By clicking on the Medicinal Product by MAH tab the user can access the list of authorised products categorised based on the relevant MAH they can have access to.
The button on the top left side “Drill Up/Drill Down” allows user to visualize product grouped by MAHs or simply the ORG ID and LOC ID of the MAH the user can have access to.
By clicking on the Product(s) of my Organisation tab only product data owned by the organisation the user has access to can be visualized. In this case data are grouped in a way that the user can easily identify which EV code correspond to the correct PMS ID / product entity.
Manufacturing operations report
This dynamic report type allows the user to access all the manufacturing operation data related to the owned product(s).
The main page provides an overview of the PMS ID and product entities available under your organisation. To access detailed information on manufacturer data, user can click on the above grey button named “Manufacturer”.
User can go back to the previous page listing all owned products by clicking on the grey button named “Medicinal Product”.
The grey button named “Operations” provides access to dataset as foreseen in the Manufacturing Business Operation class in the EU IG Chapter 2.
All Ingredient report
This dynamic report type allows the user to access all ingredient information related to the owned product(s).
The grey button named “Ingredient” provides access to the full list of substances referring to the relevant owned products.
User can go back to the previous page listing all owned products by clicking on the grey button named “Medicinal Product”.
User can further access the strength of the substance composition by clicking on the grey button named “Strength”.
All packages report
This dynamic report type allows the user to access all packages data related to the owned product(s).
User can further access package related information by clicking on the grey button named “Packages”.
Due to the high volume of data available in this report, it is suggested to further refine the research. User can apply any filter as reported in the tab available to the right side of the page. This will streamline the research and reduce the time to get results by the system.
This will streamline the research and reduce the time to get results by the system.
All ATC code report
This dynamic report type allows allows the user to access and identify the product(s) they own based on ATC code.
By selecting the ATC code i.e. A04AA05 the report will generate a list of authorised products data containing only the selected ATC code.
Multiple selections are possible in this type of report.
User can also run queries at the level of the Manufacturing Operation and Package level:
To go back to the main report type page user can click on “Medicinal Product” tab available at the bottom (left side) of the screen.
Human medicinal product overview public report
This type of report is accessible without previous registration. It is therefore publicly accessible.
Nevertheless, if registered users are logged into PUI portal they can access this report without logging out.
The public report is available in the section “Medicinal Product” under SPOR tab on the top (right side) of the screen.
Before accessing the data, the user is required to read the following statement:
Once the statement is read, to access data user shall click on the “close” button.
In the public report data are accessible based on the following criteria at medicinal product level:
- PMS ID
- Full Name
- Authorised Dose Form
- RMS ID
- MAH/Owner
- LOC ID
- MA nr.
- ATC code
- Active Substance
- Substance Code
- Authorisation Country
- Authrisation Status
- MRP/DCP/CP Nr.
Nevertheless, users can visualise product data at packaged medicinal product level:
- PMS ID
- Full Name
- Authorised Dose Form
- RMS ID
- MAH/Owner
- LOC ID
- MA nr.
- ATC code
- Active Substance
- Substance Code
- Authorisation Country
- Authrisation Status
- MRP/DCP/CP Nr.
- MA Number (at packaged medicinal product level)
- Pack size
Additionally, product data are accessible also at product composition level:
- PMS ID
- Full name
- Authorised dose form
- RMS ID
- Administrable Dose Form
- ATC Code
- Substance
- Substance Code
- Substance Reference
Note: the above report may be subject to update over the time. More reports might be added based on the requirement and development.
Support
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 PMS PUI portal.
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 – PMS PUI, to create a ticket for the issue you are experiencing;
- Request information about the PLM Portal – PMS 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 – PMS PUI General (topics covering multiple aspects and/or general nature)
- PLM portal – PMS Product Data (issues and questions with the product data as exposed/published in PUI)
- PLM portal – PMS PUI access (issues and questions on the access to PUI)
- PLM portal – PMS 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.
Figure 1 - Report an issue with PLM Portal - PMS PUI
Figure 2 - Request for Information about PLM Portal – PMS PUI