Purpose and context
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 PLM Portal - 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 on how to request an EMA account and how to 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.
To sign in users shall click on the below blue button "Sign in with an EMA account".
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)
- LOC ID
- 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 should scroll down through the results of a 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 on the left side 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 advised to work with multiple tabs simultaneously to retain 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.
My workspace area
In the My Workspace section the user can access to all the created Change Request for the Organisation they have access to. Therefore, registered users can access CRs created by other users registered for the same Organisation (ORG-ID). Furthermore, users can view and collaborate (when having sufficient rights) on Changes created by another user of my organisation.
To access My Workspace area the user should select the My Workspace section from the drop-down menu available under Products Management Service.
Accessing a Change Request in My Workspace
Users can access a Change Request (CR) from the My Workspace area using one of the following methods (refer to the image above):
- Arrow Icon – Click the arrow icon to the right side of the dark blue bar.
- PMS ID – Click on the PMS ID of the medicinal product.
Both options will direct the user to the main product data page in read-only mode, meaning product data cannot be edited.
Searching a Change Request in My Workspace
Users can search for a Change Request (CR) in the My Workspace area using the search function located at the top right corner of the page (refer to the image below).
Search criteria include:
- Change Request number
- Friendly Name
- Type
- Status
- Created on
- Modified on
- Created by
- Modified by
Change Requests status guide
Change requests created in PUI can have the following statuses:
1. Draft
- The initial stage where a product is selected, and a change request (CR) is created, but no data is modified yet.
- If a CR was created by mistake and the user has not yet clicked on “Continue to Edit,” it can be removed from My Workspace > Draft CR by clicking the “Remove” button.
- Once removed, the CR will disappear from My Workspace.
2. Modified
- At this stage, changes have been made to the draft CR but it has not yet been submitted for integration.
- If a Change was created by mistake and the user has clicked on “Continue to Edit” but not yet submitted it to PMS, it can be removed from My Workspace > Modified CR by clicking the “Deactivate” button. This action can also be performed by another user with sufficient rights of the same organisation.
- Once deactivated, the Change moves to the Cancelled section in My Workspace.
3. Submitted
- The Change has been successfully submitted for integration and is awaiting processing.
- It transitions from either Draft or Modified status upon submission.
- Note: In future development, the submitted Change will include a list of submitted changes.
4. Integrating
- This is an intermediate status after submission, before the Change is fully processed and marked as Completed.
5. Completed
- The Change has been fully integrated, and the process is finalized.
6. Cancelled
- A Change that was in Draft or Modified status but was deactivated before submission.
- A Change that, after submission, failed validation or was partially completed and automatically moved to Cancelled status.
- If a Change fails validation or is only partially completed, the Marketing Authorization Holder (MAH) must create a new Change for the same product/changes.
- If the new Change fails again, contact the EMA Service Desk by submitting an incident ticket.
7. Integrating Validation
- The Change failed validation during the integration process due to an issue.
- Changes with this status will show under Submitted tab until the CR will be marked as Failed.
- Note: In future development, the submitted Change will include a list of submitted changes.
8. Integrating/Partially Completed
- At least one product in the Change was successfully completed, but at least one failed.
- Changes with this status will show under Submitted tab until the CR will be marked as Failed.
- Note: In future development, the submitted CR will include a list of submitted changes.
Important Notes
- Changes in intermediate statuses (other than Draft, Modified, Submitted, Completed, or Cancelled) cannot be searched.
- However, users can still view such Changes by keeping the Change details page open in their browser.
Product data submission in PMS PUI
As of January 2025, registered users can electronically submit a limited set of structured product data for non-Centrally Authorized Products (non-CAPs) through the Product User Interface (PUI).
The structured product data allowed for electronic submission includes:
- Manufacturing information (as per section 2 of EU IG Chapter 2)
- Pack size (as per section 5.5 of EU IG Chapter 2)
For detailed business rules on submitting this dataset in PMS, please refer to EU IG Chapter 2, Chapter 3, and the webinar presentations from 25 November 2024, titled "Submission of Manufacturers, Manufacturing Business Operations (MBOs), and Structured Pack Size Data to Product Management Service (PMS)." and 28 January 2025, titled “Product Management Service (PMS) webinar on Product User Interface (PUI) edit functionalities for industry users”.
Currently, only the above-listed data elements can be updated in PMS for non-CAPs. Data carrier identifier(s) (as per section 5.9.6 of EU IG Chapter 2) will be available in Q2 2025 in UAT.
Creation of the Change Request
To update authorised product data in PMS PUI, registered users must first log in to the portal and select the product requiring data enrichment.
Single product within a Change
Users can update product information in the PMS PUI by selecting the relevant product and initiating a Change. The steps below outline the process.
Steps to Update Product Information
- Select the Product
- Tick the empty box next to the product to select it.
- Click on the Edit Data button.
2. Initiate the Change
- The system will begin creating a Change.
- Assign a friendly name and a description to the Change for easier identification.
- Use the description field to list all changes made to the product data.
3. Cancel or Proceed with the Change Creation
- Clicking Close will cancel the Change.
- Clicking Next will proceed to the Change Detail page.
Change Detail Page
The following elements are displayed:
- Friendly Name (editable free text)
- Description (editable free text)
- Type (default set to "Enrichment")
- Change Activities identifiable by PMS ID, Full Name, Type, Status and Message
- Selected Product(s) identifiable by PMS ID, Full Name, MAH Holder, MA Nr., Authorisation Country, and Authorisation Status.
- Clicking on the PMS ID directs the user to the medicinal product entity view page.
Editing Change Details (Before Submission)
To update the Change details before submission:
- Click on the respective field (Friendly Name or Description) and enter the updated text.
- Click the Save button.
- The system will confirm with the message: "Change saved successfully."
Additional Information displayed at the top of the Change Detail page:
- Change ID
- Type (default: Enrichment, per EU IG Chapter 3)
- Status
- Created by
- Created on
- Last updated by
- Last updated on
Once the Change is submitted, its details cannot be edited.
Multiple products within the same Change
Users can select multiple products within the same Change. However, changes must currently be applied manually to each product. The selected products will be listed within the created Change, allowing users to update them individually.
Steps to Edit Multiple Products in a Change
- Select Multiple Products
- When creating a Change, select the products (maximum 50) that require modifications. The limit of 50 products will extended to 500 by Q2 of 2026.
- The selected products will be included in the Change list.
2. Access the Edit Mode
- Click on the “Continue to Edit” button to proceed with updating the selected products.
3. Navigate Between Products
- Use the drop-down menu to view the list of selected products.
- Click on the arrow to expand the drop-down menu and select a product.
- Each product must be updated individually.
4. Apply Changes
- Update the required data for the selected product.
- Once changes are made, navigate to the next product using the drop-down menu.
- Repeat the process for each product in the list.
Update Manufacturer(s) product data
Single product editing
When the Change is created and is marked with the status “Draft” the registered user can start amending the relevant products data. As of January 2025, a limited data set of PMS elements can be updated by the registered user.
To update the product manufacturer data, is sufficient for the user to retrieve the Change previously created and click on the button “Continue to edit” (red box in the picture below). To read-only the product data user can instead click on the relevant PMS ID link available within the Change (green box in the picture below).
As of Q2 2025, a new "Clone Change" button has been introduced in PUI. This functionality is designed to help users quickly resubmit change requests that were previously unsuccessful.
By selecting "Clone Change" users can generate a new change request with the same product(s) automatically preselected, simplifying and speeding up the submission process.
To start submitting manufacturers data, users should click on the “Manufacturer” section available at the level of the Medicinal Product and click on the “+ Add Manufacturer” button.
Currently, all manufacturer sites and operational data related to authorised medicinal products can only be submitted at the medicinal product level. This means that if data regarding the primary packaging needs to be reported, it must be done at the medicinal product level, as the "Add Manufacturer" button is only available there.
The PUI system will display a window to select the most relevant manufacturer information:
To select the relevant manufacturer data, user should click on the search icon by using the LOC ID or the Organisation name.
The full list of data from OMS will be displayed for selection purposes. Once selected the user should click on the “select” button to see the manufacturer data from OMS in the overview page.
Assuming that the OMS manufacturer data is correctly selected, the user can click on “Save” to see the information reflected in the product page.
If the user clicks on the “Save & New” button, the system will allow the user to save the currently selected OMS manufacturer data and open a new search window to select an additional manufacturer.
Once the Manufacturer has been selected and properly saved as mentioned above, the user can start adding the relevant Manufacturing activity by clicking on the “+ Add Manufacturing Operation” button.
The below window will be displayed:
The Manufacturer details section contains all the relevant information referring to the previously selected manufacturer. Please note that these data are stored in OMS, the source system.
In the Manufacturing business operation, there are the following data elements to populate as per EU IG Chapter 2 rules. The fields having the red * (star) close to the data element name reported refers to the mandatory conformance:
- Operation type*: by clicking on the search icon the user can select the most applicable operation and click on the “Select” button confirm the choice.
Note: The user can also search for the relevant operation type in the search box (free text) by typing the term as it starts in the RMS list and click on the search icon to run the query. Alternatively, users can use the star key to be included between each word to optimize the research a specific term. The example below will return choices with text or no text before active and with no text between active and substance.
A lookupd like active* will only return choices with values or no values behind active. Choices that have a text value before active (e.i. 'only active') will not be displayed as a choice.
- Manufacturing operation start date*: select the most appropriate date by clicking on the calendar icon and click on the “Select” button to confirm the choice. The format is DD/MM/YYYY.
- Manufacturing operation end date: select the most appropriate date by clicking on the calendar icon and click on the “Select” button to confirm the choice. The format is DD/MM/YYYY.
- Confidentiality Indicator*: select whether the operation type is deemed Confidential or Public and click on the “Select” button to confirm the choice. The default setting of the confidentiality indicator depends on the selected operation type (i.e. batch release operation type will have public as the default value for the confidentiality indicator).
- Manufacturing authorisation reference number: This is a free text field.
- Effective date: select the most appropriate date of the Manufacturing authorisation documentation by clicking on the calendar icon and click on the “Save” button to confirm the choice. The format is DD/MM/YYYY.
- Medicines regulatory agency organisation*: Select the most appropriate medicine regulatory agency organisation issuing the Manufacturing authorisation documentation and click on the “Save” button to confirm the choice.
When all manufacturer data have been reported, click on the “Save” to let the system process the information. The entered product information relevant for the manufacturer business operation are displayed in the main product page:
If the user clicks on “Save and new” the system will process the previously entered information and open immediately another window to allow the user to select an additional operation type with its relevant details to be displayed in addition to the first one on the main product page.
At the bottom of the page, there is blue arrow icon. If the user clicks on it two additional buttons are displayed:
- Edit: use this button to update any of the data previously entered. Below an example of the edited Manufacturing authorization reference number. After entering the updated information, user should click on the “Save” button to confirm the choice.
- Remove: use this button to remove from the product page the previously entered data. To confirm the removal of the data the system displays the following warning message:
When the user has fulfilled all elements and reported all the required information, the next step is to click on the “Validate” button to let the system process the data and run the validation rules. By clicking on this button, the system will check whether all mandatory elements have been successfully fulfilled.
Upon completion of the data validation the system will display a positive validation message.
In case the user has deleted the manufacturer business operation type or not entered all mandatory elements, the result of the validation will be negative and provide an error. This is because there are data elements which are mandatory to provide as per EU IG Chapter 2.
To submit the changes, please refer to the section named “Submit the Change” available in this guide.
Multiple Products editing
When multiple products need to be updated with the same information, this functionality allows for efficient bulk editing.
- Select Multiple Products: Begin by selecting all the products that require the same updates.
- Initiate the Change: Once selected, the system will create a change entry that includes all the chosen products.
3. Edit One Product First: Click the Edit button on any one of the selected products to enter the necessary updates. Alternatively click on Continue to Edit button and select from the drop-down menu the product to update.
4. Validation: Then, click the Validate button to ensure all required fields are completed correctly. Once validated, the changes can be applied to the remaining selected products.
5. Apply Changes to All Selected Products: To propagate the same updates to the remaining selected products, return to the Change Details section in the Workspace area (located at the bottom-left of the product page), and click the Bulk button of the product that you just have updated.
6. Bulk Operation Window: A Bulk Operation window will appear, prompting you to select the following:
a. Select Operation Type: Type of action to perform
- Clone/Copy - Choose this option to duplicate the exact information entered for the first product across all selected products.
- Remove - Select this if you want to delete the same information from all selected products.
b. Affected Area Type: Specifies the category of product data elements where the selected operation will be applied.
c. Source Selection: Choose the product data to copy or remove, depending on the selected operation type. The selection can be made at a higher level (e.g., entire sections or attributes) or a lower level (e.g., specific fields), based on the data the user intends to duplicate or delete. To select the lower level, i.e. manufacturer operation types user can expand the section and select the relevant value(s).
Once selection is made, click the Next button to proceed.
d. Target products: The system will prompt you to select the products to which the data should be cloned or from which it should be removed. After making your selection, click the Next button to continue.
e. Confirmation Prompt: A message will appear prompting you to click the Apply button to confirm and execute the selected bulk operation.
f. A temporary message is displayed that editing is temporarily unavailable during the bulk update
g. Changes Applied: The selected updates will be applied to the chosen products, and the outcome of the operation will be displayed in the Change Activities table.
7. Verify Changes: To confirm that the changes have been correctly applied to the selected products, click the View button next to each product listed under the Selected Products section within the change record.
8. Validation: After reviewing the changes, click the Validate button to confirm and finalize the operation. During validation, the system will display notification messages related to the product data. These messages should always be reviewed carefully, and any necessary actions should be taken as indicated in each notification.
9. Refresh: The refresh can be used if the validation of a change detects a version mismatch between the product in the CR and PMS. The user can manually trigger the refresh of the products via the Refresh button; this button has become enabled due to the mismatch.
Please note that it can take up 48 hours between creation of the version in PMS and synchronisation into PLM-UI, hence to have a successful refresh.
The system will require the user to consent with the refresh
The system will provide a message that the refresh was successful, and the refresh button becomes disabled.
To submit the changes please refer to the section named "Submit the Change" available in this guide.
Updating Pack Size (s) product data
Single Product Editing
Users can submit structured pack size(s) product data by clicking on the Packaged Medicinal Product on the product view page and click on the blue arrow icon and on “Edit” button of the selected package. Only the “Edit” button is allowed to be selected. If user tries to click on the “Remove” button the system will prevent you to continue.
The following window will pop-up to structure the relevant pack size data:
The elements to fulfil are the Unit of presentation and the Quantity. By clicking on the “+ Add structured pack size data”:
By clicking on Unit of presentation field the look up will pop-up and display all the available RMS records for selection. To search for the record the user can also use the search functionality.
To select the record is sufficient to tick on the box close to the term and click on “Select” to let the system process the entered data:
The quantity field is instead a free text field where only number can be entered. If the use enters the non-numeric values and save it the system will display and invalid message asking the user to enter the most appropriate value:
Once the values have been entered the user should click on “Save”. The data are then displayed as per below:
If the user is fine with the entered data, the next step is to click on “Save” to see the data reflected on the product page:
In case of multiple pack sizes available for the same product, the same described process applies.
When the user has fulfilled all elements and reported all the required information, the next step is to click on the “Validate” button to let the system process the data and run the validation rules.
By clicking on this button, the system will check whether all mandatory elements have been successfully fulfilled. Upon completion of the data validation the system will display a positive validation message.
In case the user has deleted the structured pack size or did not enter all mandatory elements, the result of the validation after clicking on the “Save” button will be negative and provide an error. This is because there are data elements which are mandatory to provide as per EU IG Chapter 2.
To submit the data carrier identifier information, please refer to the section named “Update Data Carrier Identifier(s) product data” available in this guide.
Multiple Products editing
When multiple products need to be updated with the same information, this functionality allows for efficient bulk editing.
- Select Multiple Products: Begin by selecting all the products that require the same updates.
- Initiate the Change: Once selected, the system will create a change entry that includes all the chosen products.
- Edit One Product First: Click the Edit button on any one of the selected products to enter the necessary updates. Alternatively click on Continue to Edit button and select from the drop-down menu the product to update.
4. Validation: Then, click the Validate button to ensure all required fields are completed correctly. Once validated, the changes can be applied to the remaining selected products.
5. Apply Changes to All Selected Products: To propagate the same updates to the remaining selected products, return to the Change Details section in the Workspace area (located at the bottom-left of the product page), and click the Bulk button.
6. Bulk Operation Window: A Bulk Operation window will appear, prompting you to select the following:
a. Select Operation Type: Type of action to perform
- Clone/Copy - Choose this option to duplicate the exact information entered for the first product across all selected products.
- Remove - Select this if you want to delete the same information from all selected products.
b. Affected Area Type: Specifies the category of product data elements where the selected operation will be applied.
c. Source Selection: Choose the product data to copy or remove, depending on the selected operation type. The selection can be made at a higher level (e.g., entire sections or attributes) or a lower level (e.g., specific fields), based on the data the user intends to duplicate or delete. To select the lower level i.e. manufacturer operation types user can expand the section and select the relevant value(s). Once selection is made, click the Next button to proceed.
d. Target products: The system will prompt you to select the products to which the data should be cloned or from which it should be removed. After making your selection, click the Next button to continue.
e. Confirmation Prompt: A message will appear prompting you to click the Apply button to confirm and execute the selected bulk operation.
f. Changes Applied: The selected updates will be applied to the chosen products, and the outcome of the operation will be displayed in the Change Activities table.
7. Verify Changes: To confirm that the changes have been correctly applied to the selected products, click the View button next to each product listed under the Selected Products section within the change record.
8. Validation: After reviewing the changes, click the Validate button to confirm and finalise the operation. During validation, the system will display notification messages related to the product data. These messages should always be reviewed carefully, and any necessary actions ahould be taken as indicated in each notification.
To submit the changes please refer to the section named "Submit the Change" available in this guide.
Update Data Carrier Identifier(s) product data
The data carrier identifier update will not be released into production until the go-live of the portal.
Users can submit structured Data Carrier Identifier(s) product data by clicking on the Packaged Medicinal Product on the product view page and expand the package section. The user will see the section named “Data Carrier Identifier(s)” click among other sections created as per EU IG Chapter 2.
By clicking on the “+ Add Data Carrier Identifier” button the below window will pop-up to enter the relevant values:
User can enter the following product data:
- Identifier Value: a free text field.
- Identifier System: a data element exposing RMS terms for selection purpose. The search function can be used to retrieve the most appropriate RMS term from the ‘Source of Information’ RMS list since this list has a broad scope and it contain terms not applying to this PMS data element.
When the values are included, click on Save to see the data reflected in the overview Data Carrier Identifier(s) page.
By clicking again on Save the system will process the data and display it in the main product page as shown below:
Submit the Change
1. Accessing the Change
Option 1: From the Medicinal Product Page
- Navigate to the "My WorkSpace" area, located at the bottom left side of the screen.
- Click on the "Change detail" section to access Change details.
- The system will direct you to the relevant Change window.
Option 2: From the Product Management Service Drop-down Menu
- At the top right of the screen, click on the "Product Management Service" drop-down menu.
- Select "My Workspace" to access the Change details.
- You will be directed to the "My Workspace" page, listing all Changes handled by you and other users registered under the same ORG ID.
- Search for the relevant Change:
- Filter by Change status (e.g., Modified status for recently edited Changes).
- Use the search functionality at the top right of the screen.
5. Click on the blue arrow icon to the right of the Change row.
6. Click on the "Edit Change" button to proceed in updating the Change or “Edit Product” to proceed in updating the selected product.
2. Additional Functionalities
- Edit Product: Redirects to the main product page for further updates.
- Deactivate: Cancels the Change and changes its status to "Cancelled." Use this if the Change was created by mistake.
3. Submitting the Change
- Click on the Validate button to check the data submitted/changes applied are positively validated by the system.
- Click on "Finalisation" button.
- The system will prompt a message asking for confirmation.
- Click "Submit."
- Upon submission, you will receive a Change number for tracking purposes.
- Check status updates in "My Workspace" or await notifications.
- Ensure all details are accurate before submission.
4. Post-Submission Status Updates
- The Change status transitions from Modified to Submitted, Integrating and finally to Completed once processed.
- The product data updates will be reflected in the relevant product entity within minutes, depending on the processing queue.
5. Verifying Submitted Changes
- Users can download the XML field of the product data and utilize dynamic reports for verification.
- Ensure that the previous Change update is successfully reflected in PMS PUI before submitting a subsequent Change.
- Discrepancies between PMS Product UI and PMS API versions may cause enrichment integration failures, preventing further Change submissions.
6. Accessing Completed Change Details
- Click on the "Return" button to navigate back to "My Workspace."
- The successfully submitted CR will now appear under the Completed table.
- Expand the Change and click on the PMS ID link to view updated product data in a read-only mode.
7. Cancelling a Change
If a Change is created by mistake, it can be deactivated:
- From "My Workspace," select the Change to deactivate.
- Click on the "Deactivate" button in the drop-down menu to the right.
3. A confirmation message will appear.
4. Click "Yes" to confirm deactivation.
5. The Change status will change to "Cancelled" and will be available under the "Cancelled" table for tracking.
6. Once deactivated, no further actions can be taken; users can only view the details of the cancelled Change.
Button Guide
This section explains the various types of blue and white buttons in the portal and their functions.
Light blue buttons indicate that the function is unavailable, and the button cannot be used.
List of buttons in alphabetical order:
- + Add [Data]: Open a form to add a new data
- Action buttons YES/NO: Confirm or cancel an action
- Cancel: Stop or exit the current action
- Clone Change: Create a copy of the Change record. The clone will reset all proposed product change
- Close: Exit the current window or dialogue
- Confirm: Approve or finalise an action
- Continue to Edit: Proceed with editing the selected content
- Edit Data: Make changes to existing content
- Export to XML: Save data in XML file format
- Finalisation: Complete and lock the process by proceeding with the submission
- Load More: Display additional items or results beyond the initial set
- Next: Move to the following page or step in a sequence
- Refresh: Reload the current page or data view
- Reset: Restore settings or data to their original state
- Return: Go back to the previous screen or menu
- Save & New: Save current entry and open a new blank form
- Save: Store the current changes or information
- Search: Run a search
- Select: Choose an item or option
- Submit: Send information for processing
- Validate: Check data for correctness or completeness
- View Data: Display existing information or records
System notification guide
Categories of notification messages with some examples:
- Error Messages: Indicate that something went wrong or the input is invalid, requiring the user to take corrective action.
- Warning Messages: Alert users to potential issues that might not stop the process but should be reviewed. It is however possible to continue the process.
- Info Messages: Provide helpful information not/ requiring action.
- Validation Messages: Confirm that the action was completed successfully.
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
- All ESMP Details
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
- Legal basis
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 centralised procedure is 783 (equal to 0.5%).
After the selection of the dose form "tablet" the number of centrally authorised medicinal products shows 75 as value (equal to 0.05% 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.
ESMP details
This dynamic report allows the user to access product information which is used for the ESMP platform.
The user can filter down on PMS ID using selector on top of the report.
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
- Description (nickname)
- Pharmaceutical Form
- RMS ID
- MAH/Owner
- Org ID
- LOC ID
- EMA number
- ATC code
- Active Substance
- Substance Code
- Authorisation Country
- Authorisation Status
- MRP/DCP/CP Nr.
- EU number
Nevertheless, users can visualise product data at packaged medicinal product level:
- PMS ID
- Description (nickname)
- Pharmaceutical Form
- RMS ID
- MAH/Owner
- Org ID
- LOC ID
- EMA number
- ATC code
- Active Substance
- Substance Code
- Authorisation Country
- Authorisation Status
- MRP/DCP/CP Nr.
- EU 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 (multiple authorised dose forms will be shown concatenated with a '+' sign)
- RMS ID Authorised
- Administrable Dose Form
- PMS ID Administrable
- ATC Code
- Substance
- Substance Code
- Presentation Strength
- Concentration Strength
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 any support with the PLM portal - PMS PUI, please reach out directly to the PLM Portal section of the EMA Service Desk portal (Service Now). This includes issues related to accessing the PLM portal, accessing/managing PMS data or the system performance.
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 EMA 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, or,
- Request information about the PLM Portal - PMS PUI, to create a ticket for the question you 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 documents as attachments, as these can help to solve the query a lot faster.
Figure 1 - Form to report an issue with PLM Portal - PMS PUI
Figure 2 - Form to request Information about PLM Portal – PMS PUI