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European Coalition on Homeopathic & Anthroposophic Medicinal Products

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Safety, Pharmacovigilance and Appropriate Information for Patients of Homeopathic Medicinal Products

05 Jun 2019

A detailed review of the requirements for manufacture, registration or authorisation for homeopathic medicinal products for human use, including labelling and pharmacovigilance, shows how these issues are well balanced in pharmaceutical law in Germany and the EU. It argues that the quality, safety and compliance with manufacturing requirements of these products are guaranteed and well-established.

The published study demonstrates how 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. The report shows how, 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.

The article was published in Pharmazeutische Industrie in November 2018.