In August 2022, the European Medicines Agency (EMA) released its EU IDMP Implementation Guide v2.1.1, which includes additional and updated data points to be collected in the EMA’s Product Management Service (PMS).

To accommodate the corresponding updates to the Vault RIM data model, RIM Registrations Vaults require some data to be moved from existing object records at the 23R1 General Release.

Authorised Pharmaceutical Form

In existing RIM Vaults, the Authorised Pharmaceutical Form field on the Medicinal Product object may be populated. For Vaults in which this field is populated, one new Authorised Pharmaceutical Form object record will be created with the same information.

Registered Site Role & Registered Details

The Registered Site Role object contains much of the data required to be populated within the following registered details objects:

  • Registered Active Substance
  • Registered Inactive Ingredient
  • Registered Packaging
  • Registered Product

In RIM Vaults with Registered Site Role object records, Admins can enable the Enable Registered Site Role Migration setting to assist in moving the data. Each time you enable the setting, Vault:

  • Executes an asynchronous job to assess existing Registered Site Role records and match them to the corresponding registered details record with the same unique combination of Manufacturer and Role. The Registered Site Role Mapping table shows the source Registered Site Role fields and the target registered details fields to which they are mapped.
  • Migrates the Registered Site Role data accordingly for each successful match.
  • Sends a notification containing one CSV file for each registered details object, as well as a summary file. The registered details files reflect all post-migration record data, and the summary file contains assessment results for all objects, including those which were not migrated due to errors such as duplicate or multiple matches.
  • Resets the Enable Registered Site Role Migration setting so that the job and migration process can be re-executed as needed.

Migrating Registered Details

To migrate Registered Site Role record data to corresponding registered details records:

  1. Navigate to Admin > Settings > Application Settings and select Enable Registered Site Role Migration.
  2. Vault kicks off the asynchronous migration job. When complete, you’ll receive a notification and email with links to download the registered details and summary CSV files.
  3. Review the CSV files, using the available filters to determine which Registered Site Role records Vault could not migrate. Using this information, you can create new CSV files to manually migrate the remaining records using Vault Loader.
  4. Repeat the above steps until the Registered Site Role data is migrated satisfactorily.

Registered Site Role Mapping

Registered Site Role Field (Source) Registered Active Substance (Target) Registered Inactive Ingredient (Target) Registered Packaging (Target) Registered Product (Target)
authorisation_effective_date__v effective_date__v effective_date__v effective_date__v effective_date__v
confidentiality_indicator__v confidentiality_indicator__v confidentiality_indicator__v confidentiality_indicator__v confidentiality_indicator__v
health_authority__v health_authority__v health_authority__v health_authority__v health_authority__v
manufacturing_authorisation_number__v manufacturing_authorisation_number__v manufacturing_authorisation_number__v manufacturing_authorisation_number__v manufacturing_authorisation_number__v
manufacturing_operation_start_date__v manufacturing_site_role_start_date__v manufacturing_site_role_start_date__v manufacturing_site_role_start_date__v manufacturing_site_role_start_date__v
manufacturing_operation_stop_date__v manufacturing_site_role_end_date__v manufacturing_site_role_end_date__v manufacturing_site_role_end_date__v manufacturing_site_role_end_date__v
manufacturing_site__v manufacturer_name__rim manufacturer_name__rim finished_product_manufacturer__rim,
registration__v registration__rim registration__rim registration__rim registration__rim
site_role__v manufacturing_site_role__v manufacturing_site_role__v manufacturing_site_role__v manufacturing_site_role__v