Legal regulation of poisonous medicinal plants and herbal medicines: Medico-social impact and public health risks in Bulgaria

Medicinal plants and herbal products sit at the intersection of a complex matrix of national laws and European regulations governing the medicinal, food, cosmetic, medical device, and narcotic sectors. Within this regulatory framework and pursuant to the 11 th edition of the European Pharmacopoeia, the term "herbal drug" serves as a synonym for "herbal substance", as applied in European legislation on herbal medicinal products. Comparative analysis indicates that while medical devices and cosmetics are subject to restrictive pre-control and verification mechanisms, the food and food supplement sector exhibits certain regulatory gaps. A critical focus of this study highlights the absence of a statutory definition of "poisonous medicinal plants" (PMPs) in Bulgarian legislation, which induces regulatory inconsistencies regarding their collection, storage, and accessibility. Examination of Ordinance No. 28 on pharmacy operations reveals that its Annex No. 9 lacks specific poisonous herbal substances containing potent compounds equivalent to conventional medicines. Furthermore, modest qualification requirements and a lack of advanced identification methods at herbal collection points present additional risk factors during primary control. The current regulatory framework remains fragmented, necessitating an update of Bulgarian legislation through the introduction of precise definitions, a medically supervised dispensing regime for PMPs, and innovative digital approaches for the inbound monitoring of herbal raw materials.