Legal aspects of herbalism

Legal aspects of herbalism

Legal aspects of herbalism

Herbalism, also known as phytotherapy, is a field of alternative medicine that deals with the use of plants and their components to treat and prevent disease. The use of herbs as medicine 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 Medicines Act is the most important law in Germany that regulates the production, sale and use of medicines. The term “medicines” also includes herbal remedies such as those used in herbalism. In Germany, herbal medicines must be approved in order to be sold. Approval is usually carried out by the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI).

The approval of herbal medicines

In order to receive approval as a herbal medicinal product, manufacturers must meet various requirements. This includes, among other things, studies on the effectiveness and safety of the product. These studies are carried out as part of clinical trials in which the effect of the drug is tested on test subjects. The results of these studies must be submitted to the BfArM or the PEI in order to receive approval.

Traditional herbal medicines

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

The use of herbs outside the medicinal product label

Although herbal medicines require approval, the use of herbs is not otherwise generally prohibited. The use of herbs for self-medication or as dietary supplements is permitted in Germany. However, these are foods and not medicines. However, no promises of healing may be made, as these are only permitted for approved medicines.

The role of alternative practitioners

Alternative practitioners are people who have received a license to practice medicine as alternative practitioners in Germany and are therefore authorized to carry out certain medical activities. This also includes the use of herbal medicines in the context of herbalism. Alternative practitioners are allowed to dispense and use herbal medicines, even if they do not have regular approval as medicines.

The sale of herbs

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

Conclusion

Herbalism in Germany is subject to legal provisions and regulations that must be observed. Herbal medicines must be approved to be sold, while the use of herbs outside the drug approval is permitted. Alternative practitioners are allowed to dispense and use herbal medicines, even if they do not have regular approval. No promises of healing may be made when selling herbs, as these are only permitted for approved medicines. It is important to inform yourself about the legal regulations and to comply with them in order to act legally and responsibly in the field of herbalism.

Sources:
– Federal Institute for Drugs and Medical Devices (BfArM): https://www.bfarm.de/
– Paul Ehrlich Institute (PEI): https://www.pei.de/
– Medicines Act (AMG): https://www.gesetze-im-internet.de/amg/
– Ordinance on traditional herbal medicines: https://www.gesetze-im-internet.de/amvv/
– Federal Ministry of Health: https://www.bundesgesundheitsministerium.de/