RegulatoryOfficial

German regulators ask for ADR reports to be resubmitted after online portal fault

🇩🇪 Paul-Ehrlich-Institut · Wed 28 Oct 2026

The Paul-Ehrlich-Institut and BfArM say a technical error blocked online suspected adverse reaction reports from 7 to 9 October 2026, and ask affected reporters to submit again.

The Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM) have asked people who filed a suspected adverse drug reaction report through their joint online portal in early October to repeat it. The portal is at www.nebenwirkungen.bund.de.

According to the institutes, an unexpected technical error meant no online reports could be transmitted to their databases from 9:00 on 7 October 2026 until 12:00 on 9 October 2026. The fault has since been fixed and the portal is working normally again.

The institutes stress that the disruption mainly affected voluntary reports from private individuals about suspected reactions linked to taking or being given a medicine. Legally mandatory reports that reach the federal institutes via the public health offices (Gesundheitsämter) were not affected.

Reporters can resubmit through the usual online form. Anyone who saved their original entry locally as a PDF can instead email it to pharmakovigilanz@pei.de or uaw@bfarm.de. Experts at the two institutes will then enter those reports into the adverse reaction databases manually.

What it means for your team

  • Spontaneous consumer reports submitted via the German portal between 7 October (09:00) and 9 October 2026 (12:00) did not reach the PEI or BfArM databases, so case counts for that window may be understated until resubmissions arrive.
  • Mandatory reports routed through the Gesundheitsämter were not affected, according to the institutes.
  • Companies and PV teams that advise or support patients and reporters, for example via medical information or patient support channels, may want to point them to the resubmission options.
  • Reports resubmitted late may enter the databases with later receipt dates than the original event of reporting, which is worth bearing in mind when reviewing German case data.

Official source: Paul-Ehrlich-Institut ↗

Article written by VigiEye from the official source (Paul-Ehrlich-Institut). AI-assisted; check the source before acting.

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