PMS Product UI Navigation Guidance

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).

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 CR 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.
• Once deactivated, the CR moves to the Cancelled section in My Workspace.

3. Submitted

• The CR 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 CR will include a list of submitted changes..

4. Integrating

• This is an intermediate status after submission, before the CR is fully processed and marked as Completed.

5. Completed

• The CR has been fully integrated, and the process is finalized.

6. Cancelled

• A CR that was in Draft or Modified status but was deactivated before submission.
• A CR that, after submission, failed validation or was partially completed and automatically moved to Cancelled status.
• If a CR fails validation or is only partially completed, the Marketing Authorization Holder (MAH) must create a new CR for the same product/changes.
• If the new CR fails again, contact the EMA Service Desk by submitting an incident ticket.

7. Integrating Validation

• The CR failed validation during the integration process due to an issue.
• Such CRs are automatically moved to Cancelled status.
• Note: In future development, the submitted CR will include a list of submitted changes.

8. Integrating/Partially Completed

• At least one product in the CR was successfully completed, but at least one failed.
• These CRs are automatically moved to Cancelled status.
• Note: In future development, the submitted CR will include a list of submitted changes..

Important Notes

• CRs in intermediate statuses (other than Draft, Modified, Submitted, Completed, or Cancelled) cannot be searched.
• However, users can still view such CRs by keeping the CR details page open in their browser.

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.

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 Request

Users can update product information in the PMS PUI by selecting the relevant product and initiating a Change Request (CR). The steps below outline the process.

Steps to Update Product Information

1. Select the Product

• Tick the empty box next to the product to select it.
• Click on the Edit Data button.

2. Initiate the Change Request (CR)

•  The system will begin creating a Change Request.
• Assign a friendly name and a description to the CR for easier identification.
• Use the description field to list all changes made to the product data.

3. Cancel or Proceed with the CR Creation

• Clicking Close will cancel the Change Request.
• Clicking Next will proceed to the Change Request Detail page.

Change Request Detail Page

The following elements are displayed:

• Friendly Name (editable free text)
• Description (editable free text)
• Type (default set to "Enrichment")
• 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 CR Details (Before Submission)

To update the CR details before submission:

1. Click on the respective field (Friendly Name or Description) and enter the updated text.
2. Click the Save button.
3. The system will confirm with the message: "Change Request saved successfully."

Additional Information displayed at the top of the CR Detail page:

• Change Request ID
• Type (default: Enrichment, per EU IG Chapter 3)
• Status
• Created by
• Created on
• Last updated by
• Last updated on

Once the CR is submitted, its details cannot be edited.

Multiple products within the same Change Request

Users can select multiple products within the same Change Request (CR). However, changes must currently be applied manually to each product. The selected products will be listed within the created CR, allowing users to update them individually.

Steps to Edit Multiple Products in a Change Request

1. Select Multiple Products

• When creating a Change Request, select the products that require modifications.
• The selected products will be included in the CR 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.

Future Enhancements

A bulk update functionality is planned for release in Q2 2025. This feature will allow users to update multiple products simultaneously, streamlining the editing process.

For now, please ensure each product is updated manually following the steps above.

Update Manufacturer(s) product data

When the CR 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 CR 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 CR (green box in the picture below).

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.

• 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.

• 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 structured pack size, please refer to the section named “Update Pack size(s) product data” available in this guide.

Update Pack Size(s) product data

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.

Update Data Carrier Identifier(s) product data (from Q2 2025)

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 Request

1. Accessing the Change Request (CR)

Option 1: From the Medicinal Product Page

1. Navigate to the "My WorkSpace" area, located at the bottom left side of the screen.
2. Click on the "Change request detail" section to access CR details.
3. The system will direct you to the relevant CR window.

Option 2: From the Product Management Service Drop-down Menu

1. At the top right of the screen, click on the "Product Management Service" drop-down menu.
2. Select "My Workspace" to access the CR details.
3. You will be directed to the "My Workspace" page, listing all CRs handled by you and other users registered under the same ORG ID.
4. Search for the relevant CR:

• Filter by CR status (e.g., Modified status for recently edited CRs).
• Use the search functionality at the top right of the screen.

        6. Click on the blue arrow icon to the right of the CR row.

        7. Click on the "Edit Change Request" button to proceed in updating the CR 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 CR and changes its status to "Cancelled." Use this if the CR was created by mistake.

3. Submitting the Change Request

1. Click on the "Finalisation" button.
2. The system will prompt a message asking for confirmation.
3. Click "Submit."
4. Upon submission, you will receive a Request ID for tracking purposes.
5. Check status updates in "My Workspace" or await notifications.
6. Ensure all details are accurate before submission.

4. Post-Submission Status Updates

• The CR 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 CR update is successfully reflected in PMS PUI before submitting a subsequent CR.
• Discrepancies between PMS Product UI and PMS API versions may cause enrichment integration failures, preventing further CR submissions.

6. Accessing Completed CR Details

1. Click on the "Return" button to navigate back to "My Workspace."
2. The successfully submitted CR will now appear under the Completed table.
3. Expand the CR and click on the PMS ID link to view updated product data in a read-only mode.

7. Cancelling a Change Request

If a CR is created by mistake, it can be deactivated:

1. From "My Workspace," select the CR to deactivate.
2. 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 CR 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 CR.