The Netherlands
An indexing issue has been identified affecting Geneesmiddelenbulletin (Ge-Bu) in Embase. Although Ge-Bu was listed as an active journal, articles published between January 2024 and July 2026 were not indexed. As Ge-Bu is considered by the Dutch Medicines Evaluation Board (CBG) to be a relevant Dutch literature source for pharmacovigilance monitoring, this may have resulted in a gap in routine pharmacovigilance literature screening for MAHs relying on Embase coverage.
The Dutch Association for Pharmaceutical Medicine (NVFG) has communicated on the expectations of the Dutch Health and Youth Care Inspectorate (IGJ) for MAHs that are impacted:
- Record the issue as a PV deviation, including the assessment and any resulting CAPA within their QMS, as these may be reviewed during future PV inspections.
- Perform a retrospective review of Ge-Bu publications covering the period January 2024 to July 2026.
- Assess any identified ICSRs and, where appropriate, submit unreported cases to EudraVigilance. The retrospective review date may be used as the receipt date.
MAHs should assess whether Ge-Bu is included in their literature monitoring process and whether coverage relied on Embase. Where applicable, a gap assessment and retrospective screening should be conducted and appropriately documented.
As of July 2026, Ge-Bu has been removed from the Embase journal list.
Source: e-mail communication Dutch Association for Pharmaceutical Medicine (NVFG)