If you wish to create a Product Report for a development product, you have to select "New
Development Product" in the active area.
Once you have selected "New Development Product" the tree view area and the active area will display the fields that need to be completed in the product report for a development product.
You can complete the fields as necessary, please refer to the below guidance: 3.2.2.1. Sender Local Code (DP.4)
Optional information.
The sender local code for the development medicinal product used by the sponsor for internal reference purposes may be specified in this field.
The sender local code specified by the sponsor is not used in the XEVMPD for maintenance and it can be any technical code.
3.2.2.2. Sponsor Code (DP.5)
Mandatory information.
Sponsor EV Code corresponding to the sponsor organisation of the development medicinal product must be specified, where applicable.
If the Sponsor organisation was previously successfully submitted in the XEVMPD and an EV Code has been assigned, the sponsor organisation can be selected from the available look-up table.
If the sponsor organisation does not exist in the XEVMPD, the sponsor information can be added using the Organisation section of the XEVPRM and be referenced in the DMP entry using the Local look-up table. Please refer to section 3.2.2.7. How to reference information not yet present in the XEVMPD in your DMP entry.
3.2.2.3. Product Code (DP.6.1)
Mandatory information if product name (in field DP.6.2) is not provided. Optional information if product name (in field DP.6.2) is provided.
The code assigned to a development product by the sponsor may/must be specified.
3.2.2.4. Product Name (DP.6.2)
Mandatory information if product code (in field DP.6.1) is not provided. Optional information if product code (in field DP.6.1) is provided.
The name assigned to the development product by the sponsor in the clinical trial documentation (e.g. IB) must/may be specified.
If the sponsor does not have a specific product name, and only the active substance name or code is available, the product name can be created as a concatenation of the substance code or name and concentration.
3.2.2.5. Product Other Name (DP.6.3)
Optional information.
Other descriptive name of the development product may be specified (e.g. if the product has any other name previously used by the sponsor in the clinical trial documentation).
3.2.2.6. Comment (DP.7)
Optional information, which becomes mandatory during nullification – a reason for nullification must be provided in this field (e.g. duplicated product entry).
Validate and send the XEVPRM.
The XEVPRM acknowledgement will be sent to the sender organisation ID, and if the submission was successful, will display the following message, including the EV Code of the DMP:
3.2.2.7. How to reference information not yet present in the XEVMPD in your DMP entry If some of the information you need to insert in the individual fields of your product entry is not available in the relevant look-up tables, you may add this information in the same XEVPRM, and reference it in the product entry you are creating.
As an example, in the below screenshot, you are inserting a new DMP. The sponsor organisation you need to reference is not available in the look-up table:
Go to the "Organisations" section of the XEVPRM and create a new sponsor organisation (please refer to section 3.2.7. Insert of Sponsor organisation):
Once you have created the new sponsor organisation, go to the development product entity that you started to create, click with your mouse on the field "Sponsor" and then on the button (Local data lookup).
From the pop-up menu, select the new sponsor organisation present in your XEVPRM:
You can continue to populate the remaining fields in your DMP entry. Any information that is not present in the available look-up fields can be added using the same process described above. When you enter information in all of the fields as required, validate and send the XEVPRM.
The XEVPRM acknowledgement will be sent to the sender organisation ID, and if the submission was successful, it will display the following message including the EV Code of the newly inserted DMP and the sponsor organisation:
3.2.3. Insert of an approved substance
If you wish to create a Substance Report for a new substance, you have to select "Substances" in the tree view area.
The active area allows you to create a Substance Report for an approved or for a development substance.
If you wish to create a Substance Report for a new approved substance, you have to select "New Approved Substance" in the active area.
Please note that the below screenshot is for the purpose of training only as you should follow the process described in Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information if you wish to add a new approved
Once you have selected "New Approved Substance" the tree view area and the active area will display the fields that need to be completed in the substance report for an approved substance:
You can complete the fields as necessary, then validate and send the XEVPRM.
The XEVPRM acknowledgement will be sent to the sender organisation ID, and if the submission was successful, will display the following message, including the EV Code of the approved substance: