Legal aspects of herbalology

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Rechtliche Aspekte der Kräuterkunde Die Kräuterkunde, auch Phytotherapie genannt, ist ein Gebiet der Alternativmedizin, das sich mit der Verwendung von Pflanzen und ihren Bestandteilen zur Behandlung und Vorbeugung von Krankheiten befasst. Die Anwendung von Kräutern als Heilmittel hat eine lange Tradition und ist in vielen Kulturen weit verbreitet. In Deutschland unterliegt die Kräuterkunde jedoch bestimmten gesetzlichen Bestimmungen und Vorschriften, die im Folgenden erläutert werden. Das Arzneimittelgesetz (AMG) Das Arzneimittelgesetz ist in Deutschland das wichtigste Gesetz, das die Herstellung, den Verkauf und die Anwendung von Arzneimitteln regelt. Unter den Begriff „Arzneimittel“ fallen auch pflanzliche Mittel, wie sie in der Kräuterkunde verwendet …
Legal aspects of herbalism, also called phytotherapy, is an area of ​​alternative medicine that deals with the use of plants and its components for the treatment and prevention of diseases. The use of herbs as a remedy has a long tradition and is widespread in many cultures. In Germany, however, herbal science is subject to certain legal provisions and regulations, which are explained below. The Medicinal Products Act (AMG) The Medicines Act is the most important law in Germany that regulates the manufacture, sale and application of medicinal products. The term “drug” also includes vegetable means that used in herbalism ... (Symbolbild/natur.wiki)

Legal aspects of herbalism

Herbalism, also called phytotherapy, is an area of ​​alternative medicine that deals with the use of plants and its components for the treatment and prevention of diseases. The use of herbs as a remedy has a long tradition and is widespread in many cultures. In Germany, however, herbalism is subject to certain legal provisions and regulations, which are explained below.

The Medicines Act (AMG)

The Medicinal Products Act is the most important law in Germany that regulates the manufacture, sale and use of medicinal products. The term “medicinal products” also include vegetable means that are used in herbalism. In Germany, vegetable medicines must be approved in order to be sold. The admission is usually made by the Federal Institute for Medicines and Medical Devices (BFARM) or the Paul-Ehrlich-Institut (PEI).

The approval of vegetable drugs

In order to obtain approval as a vegetable medicine, the manufacturers must meet various requirements. These include studies on the effectiveness and safety of the product. These studies are carried out as part of clinical exams in which the effect of the drug is tested on subjects. The results of these studies must be presented to the Bfarm or the PEI in order to receive approval.

traditional herbal drugs

In addition to the regular approval procedures, there is also a special regulation for traditional vegetable medicines. These medicines are based on many years of tradition and experience and can receive a simplified approval based on this. However, such products must meet certain criteria, such as a proven useful life of at least 30 years, including 15 years in the EU.

The use of herbs outside of the drug approval

Although herbal medicines need approval, the use of herbs is otherwise not fundamentally prohibited. The use of herbs for self -medication or as a dietary supplement is allowed in Germany. However, this is food and not medicines. However, no healing promises may be made, since they are only allowed for approved medicines.

The role of alternative practitioners

Alternative practitioners are people who have received a license as a naturopath in Germany and are therefore authorized to perform certain medical activities. This also includes the use of herbal drugs within the framework of herbalism. Alternative practitioners are allowed to hand in and apply plant -based medicines, even if they do not have regular approval as medicinal products.

The sale of herbs

The sale of herbs is generally allowed in Germany as long as it is not herbal drugs. Many herbs are classified as food or nutritional supplements and can be sold freely. However, it is important that no healing promises are made when selling herbs, since they are only allowed for approved medicines. It should also be noted that certain herbs are classified as poisonous and therefore only be sold under certain conditions.

FAZIT

In Germany, herbal science is subject to legal provisions and regulations that must be observed. Vegetable drugs must be approved in order to be sold, while the use of herbs outside of drug approval is allowed. Alternative practitioners are allowed to hand in and apply vegetable medicines, even if they have no regular approval. No healing promises may be made when selling herbs, since they are only allowed for approved medicines. It is important to find out about the legal provisions and to consider them in order to act legally and responsibly in the area of ​​herbalism.

sources:
- Federal Institute for Medicines and Medical Devices (BFARM): https://www.bfarm.de/
-Paul-Ehrlich-Institut (PEI): https://www.pei.de/
-Medicines Act (AMG): https://www.gesetze-im-internet.de/amg/
-Ordinance on traditional vegetable medicines: https://www.gesetze-im-internet.de/amvv/
- Federal Ministry of Health: https://www.bundesgesundheitministerium.de/