Safety, pharmacovigilance and appropriate information for patients of homeopathic medicinal products

Abstract

In Germany and in the European Union (EU), the requirements for manufacture, registration/ authorization including labelling and pharmacovigilance for homeopathic medicinal products for human use are well balanced in the pharmaceutical law. In this concept, the quality, safety and compliance with the manufacturing requirements of homeopathic medicinal products are guaranteed and well-established. The benefit-risk-ratio is continuously reviewed in the context of pharmacovigilance. At the same time, the regulations on the statement of indications, the special labelling requirements and the pharmacy-only rule in Germany ensure that the patient receives comprehensive information and qualified advice. Following the requirement for method neutrality and scientific pluralism, European and German legislators have created a system, which gives medical doctors and practitioners the option of treating their patients with medicinal products of their choice and also guarantees patients to have access to medicinal products of their choice.