With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the data model. These data model updates are automatically included in all Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 18R3.
As part of Vault’s efforts to provide better functionality, each release introduces various data model items related to features that may not be enabled in every customer vault. These items will appear in Admin, but will not have any related functionality unless the related feature is enabled.
This release includes data model changes specific to the xEVMPD standard ensure that all data necessary for compliant messaging are accounted for, displayed, and reported upon.
- Medicinal Product Registration (
medicinal_product_registration__v) object with fields:- Medicinal Product (
medicinal_prodcut__v) - Package Description (
package_description__v) - Packaging (
packaging__v) - Registration (
registration__v)
- Medicinal Product (
- Product Data Submission (
product_data_submission__v) object with fields:- Medicinal Product (
medicinal_product__v) - Message Date (
message_date__v) - Message Date Format (
message_date_format__v) - Message Dispatch Date (
message_dispatch_date__v) - Message Due Date (
message_due_date__v) - Message Number (
message_number__v) - Message Receiver Identifier (
message_receiver_identifier__v) - Message Sender Identifier (
message_sender_identifier__v) - Message Version (
message_version__v) - Operation Type (
operation_type__v) - Product Report (
product_report__v)
- Medicinal Product (
- Product Report object with fields:
- Authorised Pharmaceutical Form Code (
authorised_pharmaceutical_form_code__v) - Administered Pharm Code Text (
administered_pharm_form_code_text__v) - Administered Pharmaceutical Form (
administered_pharmaceutical_form__v) - Administered Pharmaceutical Form Code (
administered_pharmaceutical_form_code__v) - Administered Product (
administered_product__v) - Authorised Pharmaceutical Form (
authorised_pharmaceutical_form__v) - Authorised Pharmaceutical Form Code (
authorised_pharmaceutical_form_code_text__v) - Drug Product (
drug_product__v) - EV Code (
ev_code__v) - Medicinal Product (
medicinal_product__v) - MP Administered Product (
medicinal_product_administered_product__v) - Parent Section (
parent_section__v) - Product Data Submission (
product_data_submission__v) - Product Detail (
product_detail__v) - Product Report Type (
object_type__v) - Registration (
registration__v)
- Authorised Pharmaceutical Form Code (
- Product Report object types:
- Active Substance
- Adjuvant
- Administration Route
- Attachment Element
- Authorisation Element
- Authorised Product Element
- Classification Elemen__t
- Excipient
- Pharmaceutical Product Element
- Presentation Name Element
- Previous EV Code
- Therapeutic Indication Element
- xEV Root Product Report
- Product Report Item (
product_report_item__v) object types:- Active Substance
- Adjuvant
- Administration Route
- Attachment Element
- Authorisation Element
- Authorised Product Element
- Classification Element
- Excipient
- Pharmaceutical Product Element
- Presentation Name Element
- Previous EV Code
- Therapeutic Indication Element
- Product Report Item (
product_report_item__v) object with fields:- Active Substance (
active_substance__v) - Active Substance Code (
active_substance_code__v) - Active Substance Code Text (
active_substance_code_text__v) - Adjuvant Use (
adjuvant_use__v) - Administered Product (
administered_product__v) - Administered Product Active Substance (
administered_product_active_substance__v) - Administered Product Inactive Ingredient (
administered_product_inactive_ingredient__v) - Administered Product Route of Admin (
administered_product_route_of_admin__v) - Administration Route (
administration_route__v) - Administration Route Code (
administration_route_code__v) - Administration Route Code Text (
administration_route_code_text__v) - Application (
application__v) - ATC Code (
atc_code__v) - ATC Code Text (
atc_code_text__v) - Attached Document Reference (
attached_document_reference__v) - Attached Document Reference (
unbound) (attached_document_reference_unbound__v) - Attachment Code (
attachment_code__v) - Attachment Code Text (
attachment_code_text__v) - Attachment File Name (
attachment_file_name__v) - Attachment File Name Text (
attachment_file_name_text__v) - Attachment File Type (
attachment_file_type__v) - Attachment File Type Text (
attachment_file_type_text__v) - Attachment Name (
attachment_name__v) - Attachment Name Text (
attachment_name_text__v) - Attachment Type (
attachment_type__v) - Attachment Version (
attachment_version__v) - Attachment Version Date (
attachment_version_date__v) - Attachment Version Date Text (
attachment_version_date_text__v) - Attachment Version Text (
attachment_version_text__v) - Authorisation Country (
authorisation_country__v) - Authorisation Country Code (
authorisation_country_code__v) - Authorisation Country Code Text (
authorisation_country_code_text__v) - Authorisation Date (
authorisation_date__v) - Authorisation Date Text (
authorisation_date_text__v) - Authorisation Number (
authorisation_number__v) - Authorisation Number Text (
authorisation_number_text__v) - Authorisation Procedure (
authorisation_procedure__v) - Authorisation Procedure Code (
authorisation_procedure_code__v) - Authorisation Procedure Code Text (
authorisation_procedure_code_text__v) - Authorisation Status (
authorisation_status__v) - Authorisation Status Code (
authorisation_status_code__v) - Authorisation Status Code Text (
authorisation_status_code_text__v) - Classification System (
classification_system__v) - Coded Indication (
coded_indication__v) - Comments (
comments__v) - Comments Text (
comments_text__v) - Concentration Type (
concentration_type__v) - Concentration Type Code (
concentration_type_code__v) - Concentration Type Code Text (
concentration_type_code_text__v) - Drug Product (
drug_product__v) - Enquiry Email (
enquiry_email__v) - Enquiry Email Text (
enquiry_email_text__v) - Enquiry Phone (
enquiry_phone__v) - Enquiry Phone Text (
enquiry_phone_text__v) - EU Number (
eu_number__v) - EU Number Text (
eu_number_text__v) - EV Code (
ev_code__v) - EV Code Text (
ev_code_text__v) - High Amount Strength Unit (
high_amount_strength_unit__v) - High Amount Strength Unit Text (
high_amount_strength_unit_text__v) - High Amount Strength Value (
high_amount_strength_value__v) - High Amount Strength Value Text (
high_amount_strength_value_text__v) - Inactive Ingredient (
inactive_ingredient__v) - Inactive Ingredient Code (
inactive_ingredient_code__v) - Inactive Ingredient Code Text (
inactive_ingredient_code_text__v) - Date Suspension Lifted (
info_date__v) - Date Suspension Lifted Text (
info_date_text__v) - Additional Monitoring (
intensive_monitoring_status__v) - Additional Monitoring Code (
intensive_monitoring_status_code__v) - Additional Monitoring Code Text (
intensive_monitoring_status_code_text__v) - Language Code (
language_code__v) - Language Code Text (
language_code_text__v) - Legal Basis (
legal_basis__v) - Legal Basis Code (
legal_basis_code__v) - Legal Basis Code Text (
legal_basis_code_text__v) - Legal Basis Text (
Unnecessary?) (legal_basis_text__v) - Local Number (
local_number__v) - Local Number Text (
local_number_text__v) - Low Amount Strength Unit (
low_amount_strength_unit__v) - Low Amount Strength Unit Text (
low_amount_strength_unit_text__v) - Low Amount Strength Value (
low_amount_strength_value__v) - Low Amount Strength Value Text (
low_amount_strength_value_text__v) - MAH (
mah__v) - MAH Code (
mah_code__v) - MAH Code Text (
mah_code_text__v) - MedDRA Term Code (
meddra_term_code__v) - MedDRA Term Code Text (
meddra_term_code_text__v) - MedDRA Term Name (
meddra_term_name__v) - MedDRA Term Name Text (
meddra_term_name_text__v) - MedDRA Version (
meddra_version__v) - MedDRA Version Text (
meddra_version_text__v) - Medical Device Code (
medical_device_code__v) - Medical Device Code Text (
medical_device_code_text__v) - Medical Device Type (
medical_device_type__v) - Medicinal Product (
medicinal_product__v) - MP Administered Product (
medicinal_product_administered_product__v) - Medicinal Product Coded Indication (
medicinal_product_coded_indication__v) - Medicinal Product Full Name (
medicinal_product_full_name__v) - Medicinal Product Name Part (
medicinal_product_name_part__v) - Medicinal Product Registration (
medicinal_product_registration__v) - Medicinal Product Type (
medicinal_product_type__v) - Medicinal Product Type Code (
medicinal_product_type_code__v) - Medicinal Product Type Code Text (
medicinal_product_type_code_text__v) - MFL (
mfl__v) - _MFL Cod_e (
mfl_code__v) - MFL Code Text (
mfl_code_text__v) - MRP/DCP/EMEA Number (
mrpdcp_number__v) - MRP/DCP/EMEA Number Text (
mrpdcpemea_number_text__v) - Nullification Reason (
nullification_reason__v) - Nullification Reason Text (
nullification_reason_text__v) - Product Report Item Type (
object_type__v) - Operation Type (
operation_type__v) - Orphan Drug Status (
orphan_drug_status__v) - Orphan Drug Status Code (
orphan_drug_status_code__v) - Orphan Drug Status Code Text (
orphan_drug_status_code_text__v) - Package Description (
package_description__v) - Package Description Text (
package_description_text__v) - Paediatric Use (
paediatric_use__v) - Paediatric Use Text (
paediatric_use_text__v) - Previous EV Code (
previous_ev_code__v) - Previous EV Code Text (
previous_ev_code_text__v) - Medicinal Product Company Name (
product_company_name__v) - Medicinal Product Company Name Text (
product_company_name_text__v) - Product Data Submission (
product_data_submission__v) - Product Detail (
product_detail__v) - Product Detail Active Substance (
product_detail_active_substance__v) - Product Detail Inactive Ingredient (
product_detail_inactive_ingredient__v) - Medicinal Product Form Name (
product_form_name__v) - Medicinal Product Form Name Text (
product_form_name_text__v) - Medicinal Product INN/Common Name (
product_generic_name__v) - Medicinal Product INN/Common Name Text (
product_generic_name_text__v) - Medicinal Product Name (
product_name__v) - Medicinal Product Name Text (
product_name_text__v) - Product Report (
product_report__v) - Medicinal Product Short Name (
product_short_name__v) - Medicinal Product Short Name Text (
product_short_name_text__v) - Medicinal Product Strength Name (
product_strength_name__v) - Medicinal Product Strength Name Text (
product_strength_name_text__v) - QPPV (
qppv__v) - QPPV Code (
qppv_code__v) - QPPV Code Text (
qppv_code_text__v) - Registration (
registration__v) - Renewal Date (
renewal_date__v) - Sender Local Code (
sender_local_code__v) - Sender Local Code Text (
sender_local_code_text__v) - Validity Declaration (
validity_declaration__v) - Withdrawn Date (
withdrawn_date__v) - Withdrawn Date Text (
withdrawn_date_text__v)
- Active Substance (
We are also adding five inactive document fields as shared fields that need to be set to active and associated to the appropriate type of documents for xEV Printed Product Information (PPI). These fields are in the new document field section of “XEV”, although customers can move these fields to other display sections:
- Medicinal Product (allows linking to the Medicinal Product for xEV Generation)
- EV Code (for the PPI document)
- Language
- Attachment Version
- Attachment Version Date