Discontinuation of additional risk minimisation measure tools for centrally authorised medicinal products in the EU

Data sources

• Data source(s):
  Other data source
• Data sources (types):
  Other
• Data sources (types), other:
  Publicly available regulatory documents (EPARs, PIs, RMPs) and EMA internal assessment reports.

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  Not applicable