Vault can aggregate Identification of Medicinal Products (IDMP) data for you, offering a simple way to compile product data before submitting it to the European Medicines Agency (EMA). Vault uses a series of algorithms to compile existing submission data in your RIM Registrations Vault into the IDMP object structure.
An Admin must perform some configuration before you can generate IDMP data. See IDMP Configuration for details.
Note: This feature is only available on RIM Registrations Vaults. IDMP is an evolving functionality in Vault RIM, and we will continue to add features in future releases.
Working with Medicinal Products
Before you generate IDMP data, you’ll need to do the following:
- Relate the Medicinal Product record you want to report on to at least one Registration record using the Medicinal Product Registration join object. Ensure that all relevant fields are populated on the Registration record.
- Associate packaging to the Medicinal Product Registration for IDMP generation. Your Admin may configure an action to allow you map Registered Packaging records to Medicinal Product Registration records, or mapping may occur automatically when Registered Packaging records enter specific lifecycle states. See details about Medicinal Product Registration mapping below.
- If your product is centrally authorised, create one Medicinal Product record for each licensed product. Create one Medicinal Product Registration record for the European Union and one for each of the following countries: Iceland, Norway and Liechtenstein.
- If your product is authorised through a mutual recognition procedure (MRP), decentralised procedure (DCP), or national procedure, create one Medicinal Product record for each authorised product in each country, and related Medicinal Product Registration records for each local language. For example, a product registered in Belgium through DCP with two packaging configurations should have six Medicinal Product Registration records, one for each combination of packaging configuration and language required for Belgium (Dutch, French, German).
- Relate at least one Administered Product record and at least one Medicinal Product Full Name record to the target Medicinal Product record.
About Automatic Record Creation
When the various IDMP accelerators are enabled, Vault can automatically create related records when you create new records for certain objects that support IDMP. Automatic record creation helps streamline the data entry process while ensuring that data is more accurate. Vault sends you a notification after automatic record creation completes.
Medicinal Products
Note: For centralised procedures, Vault will create a Medicinal Product for the EU and a Medicinal Product Registration record for the record identified as the lead market for Medicinal Product details. The field Vault uses to identify the country is configured in Vault Admin. The lead market for Medicinal Product details may not be EU. Vault will not create a Medicinal Product record unless a Registration exists for the lead market.
When you create Marketed Drug Product Registration-type Registration records, Vault references the Registration source record and creates the following related records:
|
Source Record |
Related Object Record Created |
Populated Fields |
Notes |
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Registration |
For each unique combination of Country, Product, Product Variant, and Application on the Registration record, Vault creates one (1) Medicinal Product record. |
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Vault creates one (1) Medicinal Product Registration record for each Registration that matches values in the following fields on a Medicinal Product record: Country, Product, Product Variant, and Application. |
Fields from Registration:
Fields from Medicinal Product:
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The following fields must be populated in order for Vault to create Medicinal Product Registrations:
If the Procedure Type is Centrally Authorized, Vault only creates Medicinal Product Registration records for the lead market. If the Procedure Type is non-centralised, Vault creates one (1) Medicinal Product Registration record for each Registration related to the Medicinal Product. |
Registered Details
When you create the following registered details, Vault creates related records and populates fields:
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Source Registered Detail Record |
Related Object Record Created |
Populated Fields |
Notes |
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Registered Packaging |
Vault creates one (1) Registered Packaged Medicinal Product for each unique combination of Registration and Packaging. |
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Both fields must be populated on Registered Packaging in order for Vault to create related Registered Packaged Medicinal Products. If the Registered Packaged Medicinal Product and Registered Packaging objects have object types with the same API name, Vault creates Registered Packaged Medicinal Product records of that object type. |
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Registered Packaging Registered Active Substance Registered Inactive Ingredient Registered Drug Product |
Vault creates one (1) Registered Site Role for each unique combination of Manufacturer and Manufacturing Site Role. |
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The Registration and Manufacturer fields must be populated on the source record in order for Vault to create Registered Site Roles. |
Medicinal Product Registrations
When configured, Vault can map Registered Packaging records to related Medicinal Product Registration records. If your Admin configured this as an entry action, mapping may occur automatically when Registered Packaging records enter specific lifecycle states. If your Admin configured this as a user action, you can select the Link Packaging to MP-Registration action from the Registered Packaging record’s Actions menu.
When this action runs, Vault checks whether a Registration has related Medicinal Product Registration records. If there are related Medicinal Product Registration records, Vault populates the Registered Packaging field on these records. If the Registered Packaging field is already populated on Medicinal Product Registration, Vault creates additional Medicinal Product Registration records as needed based on national licensing requirements. If there are no Medicinal Product Registration records related to the Registration record, no mapping occurs.
Note that if your organization does not track EV Codes at the pack level, mapping may impact EV Codes assigned to the Medicinal Product Registration records.
Generating IDMP Records & Elements from a Regulatory Objective
Vault can generate IDMP data and all related elements from a Regulatory Objective record. Depending on your Vault’s configuration, IDMP record creation may occur automatically when the Regulatory Objective record enters a specific lifecycle state.
If record creation doesn’t occur automatically, select Generate IDMP Records from the Regulatory Objective record’s Actions menu. This action may have a different name depending on your Vault’s configuration. You will not see this action if there are no Registration records related to this Regulatory Objective record. If the Regulatory Objective record has more than one related IDMP Product Data Submission record for the same Medicinal Product, Vault will not create new IDMP records and you will receive a notification.
About IDMP Record Generation
To generate IDMP data, Vault first looks at the Registration records related to the Regulatory Objective record. Then, Vault identifies the applicable Medicinal Product records related to those Registration records. For each applicable Medicinal Product record, Vault creates one (1) IDMP Product Data Submission record and generates IDMP elements. Record creation is asynchronous, allowing you to perform other tasks while Vault generates the data.
Vault sends you a notification after generating IDMP records, including a CSV file that indicates which elements Vault created and what errors occurred, if any. Note that these errors are simply a set of warnings, and Vault still generates the IDMP elements. On the Regulatory Objective record detail page, scroll to the IDMP Product Data Submission section to see the records that Vault created. From there, you can view related IDMP elements.
Generating IDMP Elements from a Medicinal Product
You can also generate only the IDMP elements for a single Medicinal Product:
- Create an IDMP Product Data Submission record from the target Medicinal Product record detail page.
- From the IDMP Product Data Submission record’s Actions menu, select Generate IDMP Elements. This action may have a different name depending on your Vault’s configuration. This process is asynchronous, allowing you to perform other tasks while Vault generates the data.
Vault sends you a notification after generating IDMP elements, including a CSV file that indicates which elements Vault created and what errors occurred. Note that these errors are simply a set of warnings, and Vault will still generate the IDMP elements.
Viewing IDMP Elements
After Vault generates the IDMP elements, you can expand the IDMP Medicinal Product Element section on the IDMP Product Data Submission record detail page. The IDMP Medicinal Product Element record that Vault created contains all of the aggregated IDMP element data. Click the record to open it and view element details and related records.
When configured by an Admin, you can also use the IDMP Viewer to review IDMP Product Data Submission records in scope of a given Regulatory Objective.
Related Permissions
To generate IDMP data, you need the following permissions:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Objects: Medicinal Product: Create, Edit | Ability to create and edit Medicinal Product records. |
| Security Profile | Objects: IDMP Product Data Submission: Create, Edit | Ability to create and edit IDMP Product Data Submission records. |
In addition, you must have at least Read access on all IDMP Element objects: IDMP Admin Ingredient Manufacturer, IDMP Admin Product Ingredient Element, IDMP Attachment, IDMP Component, IDMP Component Material, IDMP Container, IDMP Container Data Carrier, IDMP Container Material, IDMP Container Reference Item, IDMP Manuf. Item Ingredient Manufacturer, IDMP Manufactured Item, IDMP Manufactured Item Description, IDMP Manufactured Item Ingredient, IDMP Manufacturing Site, IDMP Marketing Authorisation Element, IDMP Master File, IDMP Medicinal Product Element, IDMP Medicinal Product Full Name, IDMP Medicinal Product Indication, IDMP Name Part, IDMP Package Authorisation Status, IDMP Package Description, IDMP Package Marketing Status, IDMP Packaged Medicinal Product Element, IDMP Pack Size, IDMP Pharmaceutical Product Description, IDMP Pharmaceutical Product Element, IDMP Product Cross Reference, IDMP Reference Strength, IDMP Regulatory Authorisation, IDMP Shelf Life, IDMP Storage Precautions, and IDMP Therapeutic Indication Element.