Legal status of Medirud®Biebertal (medicinal leeches) as Drug / Medicinal Product
The German health authority so far is the only legislator in the EU to classify medicinal leeches as proprietary medicinal products. The reason behind is that leech therapy has become an important therapy of complementary medicine with hundred thousands of applications in the recent years.
In Germany, the proprietary medicinal product Medirud®Biebertal (medicinal leech) of the Biebertaler Blutegelzucht GmbH (Ltd.) is currently undergoing the approval procedure of the scientific proof of safety, efficacy and quality. At present, only two German producers are allowed to place medicinal leeches on the market. Both companies are subject to regulatory quality control. You may recognise these companies by the regulatory certificate of manufacture. One of these companies is the Biebertaler Blutegelzucht GmbH. You may inspect the current certificate of Good Manufacturing Practice (GMP) here: GMP Certificate
These companies have the exclusive right and obligation to mail the package insert together with the shipment of the medicinal leeches to the customer. The package insert informs you on the important risks and adverse events of leech therapy, and you receive information on the safe use of the medicinal leeches. With these measures, pharmacies, clinics, physicians and alternative practitioners are legally secured.
We recommend strongly observing the legal status of the provider when using medicinal leeches in patients. Otherwise, you run unpredictable risks in case of occurrence of adverse events. You then might face a patient, an authority, or the court demanding accountability on the source of the medicinal leeches.
The Biebertaler Blutegelzucht GmbH has voluntarily established a Quality Management (QM) system according to DIN EN ISO 9001:2008.
You may inspect the current QM Certificate of the Biebertaler Blutegelzucht GmbH here: QM Certificate