Jurisdiction

Bulgaria

Regulation Category Type · Breadth Date

Order RD-01-646/07.12.2022 of the Minister of Health: Withdrawal of European Pharmacopoeia monographs in Bulgaria from 1 July 2023

Bulgaria withdraws four European Pharmacopoeia monographs (three vaccine formulations and anaesthetic ether) from application on its territory effective 1 July 2023.

Bulgaria BDA · Bulgaria

Pharmaceuticals Pharmaceuticals

Rule change Product class Jul 17, 2026

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PRAC recommendation: withdrawal of levamisole-containing medicines due to leukoencephalopathy risk

PRAC recommends termination of marketing authorisations for levamisole-containing medicines following confirmation of leukoencephalopathy as a serious adverse effect.

Bulgaria BDA · Bulgaria

Pharmaceuticals Pharmacovigilance

Safety alert & recall Product class Jul 17, 2026

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