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Germany Declares Shortage of Key Injectable Penicillin, Allows Temporary Imports

The move follows warnings that the sole authorized product’s bridging stock is close to running out because of delays in production changes.

Overview

  • An official shortage notice in the Federal Gazette permits time‑limited deviations from approval and labeling rules so foreign‑labeled equivalents can be used.
  • Depot penicillins are vital for preventing rheumatic complications from streptococcal infections and are the standard single‑dose treatment for syphilis, with alternatives often less effective.
  • The ministry had flagged risks since last summer as the only nationally authorized product faced production conversion delays and a bridging stock projected only into early 2026.
  • Other antibiotic substances, including cefuroxime, clindamycin, cotrimoxazole and erythromycin, are already under critical supply pressure, and such formal shortage findings have been made fewer than 20 times since 2015.
  • Authorities report roughly 550 current shortage notifications across about 100,000 authorized medicines, and EU lawmakers recently advanced a Critical Medicines Act that includes plans for an EU reserve of essential drugs.