In Germany, the registration of homeopathic and traditional herbal medicines only requires proof of quality and safety. In contrast to regular drug approval, no proof of efficacy in the conventional sense is required. Of course, an application for marketing authorization can also be submitted for both homeopathic and herbal medicines (German translation: pflanzliche Arzneimittel).

• If no indication is listed on the product, for homeopathic drugs registration (German translation: Registrierung) is sufficient for external or oral use only and only above a certain dilution factor. Sections 38 and 39 of the German Medicinal Products Act apply. Among other things, this is serves to ensure that patients with serious illnesses are given adequate treatment. The active ingredient(s) in the respective homeopathic drug (German: homöopathisches Arzneimittel) must already be established.
• When it comes to traditional herbal medicines, section 39a to d of the German Medicinal Products Act applies. Section 39a sets forth a requirement to submit “bibliographic data on the traditional use or expert reports showing that the drug in question or a corresponding drug has been in medicinal use for at least 30 years at the time of application, including at least 15 years in the European Union, that the drug is harmless under the stated conditions of use, and that the pharmacological effects or efficacy of the drug are plausible on the basis of many years of use and experience”. Here, too, only certain administration routes are permitted. It is possible to specify an indication, but only such indications that do not require medical supervision.

Drugs known as drugs of “special therapeutic directions” play a major role in the German pharmaceutical market. While proof of efficacy in the conventional sense is not required, the statutory regulations on the registration of drugs nevertheless ensure that users are not harmed.

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