Germany

Policy

In 1976, Germany introduced a national policy on TM/CAM and also all laws and regulations. In Germany, phytomedicine is accepted as part of the mainstream subject in medical and pharmacy school. As for additional qualifications relating to specific TM/CAM practices such as homeopathy and general practices such as naturopathy, modern trained medical practitioners can obtain these additional qualifications. Nevertheless, many physicians provide TM/CAM in their daily practice without having an additional CAM qualification. Other health care professionals such as pharmacists, dentists, physiotherapists or midwives may also practise some form of CAM. The “Department of Internal and Integrative Medicine” was co-opted unanimously into the University Clinic at Essen by the Senate of the University of Duisburg-Essen, is a model institution of the State of North-Rhine Westphalia at the Teaching Hospital of Kliniken Essen-Mitte. The Department's aim is to provide a scientific assessment of techniques used in complementary and Traditional Chinese Medicine. Germany implemented the reformed EU Common Agriculture Policy, which focuses on the establishment of a common organisation of agricultural markets across member countries, which also covers the sector of medicinal plants and herbs. A major new reform of the CAP is currently being prepared for the period after 2013.

Contact

Federal Ministry of Food, Agriculture and Consumer Protection
Website: http://www.bmelv.de/EN/Homepage/homepage_node.html

 

Federal Ministry of Health
Website: http://www.bmg.bund.de/ministerium/english-version.html
 

Laws & Regulations

Depending on their purpose of use, dosage, and ingredients, supplements are categorized as food products, pharmaceuticals, or dietetics.  All supplements fall under the guidance of the Ministry of Consumer Protection, Nutrition and Agriculture.  Some structure/function and nutrient function claims may be made on nutritional products.

Most botanicals are classified as medicines.  Some are classified as food products if their use is primarily nutritional.  Traditional herbal remedies are limited to botanicals of German/European origin already marked in Germany prior to 1978 with mild or prophylactic properties.  Both the European pharmacopoeia and the Deutsches Arzneibuch are considered legally binding.

Fortified or Functional Foods - Fortification of food is not regulated, though vitaminisation is.  The addition of herbs is unregulated.

Traditional Medicine status was introduced in January 1992 that permits the re-registration of traditional medicines without requiring rigorous studies and scientific data on a specific product. The standards for the approval of traditional medicines and the scientific standards for herbal drugs must be approved by Commission E in The Commissions of the German Federal Institute for Drugs and Medical Devices (BfArM). Post-marketing surveillance monitors all adverse events of herbal medicines.

In 1976, Germany not only introduced a national policy on TM/CAM, but also all laws and regulations.

Contact

Ministry of Consumer Protection, Nutrition and Agriculture                      
http://www.bmelv.de/cln
 
Ministry of Health             
http://www.bmg.bund.de/cln_041/DE/Home/homepage__node.html__nnn=true
 

The Commissions of the German Federal Institute for Drugs and Medical Devices (BfArM)

 

Standards & Guidelines

Herbal medicines have had a special standard in Germany since the Imperial Decree of 1901, which permitted trade in many botanical drugs outside of pharmacies. Germany recognized a simplified registration procedure for traditional herbal medicinal products for human use under the Directive 2004/24/EC, which is the Traditional Herbal Medicinal Products Directive. The Drug laws established upon series of EU Community Directives, in which herbal medicinal products can be registered under Directive 2001/83/EC (conventional) or Directive 2004/24/EC (traditional use). 

Commission E (phytotherapy and herbal substances) which was established in 1978 is an independent division of the German Federal Health Agency that collects information on herbal medicines and evaluates their safety and efficacy.    

The Commission E follows these methods and guidelines: 1) traditional use; 2) chemical data; 3) experimental, pharmacological and toxicological studies; 4) clinical studies; 5) field and epidemiological studies; 6) patient case records submitted from physician's files, and 7) additional studies, including unpublished proprietary data submitted by manufacturers. Two kinds of monographs are prepared which are monopreparations and fixed combinations.

Many health care professionals in Germany are providing CAM in their daily routine, whether or not they have additional CAM qualifications. Germany has one state-regulated profession which is the 'Heilpraktiker'. A 'Heilpraktiker' must possess basic medical knowledge and skills and pass an exam at a local public health office in order to obtain a state license. He or she only practices in the ambulatory sector and their services are not covered by health insurance funds. The 'Heilpraktiker' can practice any type of CAM as long as it is consistent with the general standards of good professional practice in health care as supervised by the local public health office. Within the last ten years the number of 'Heilpraktiker' increased from 9,000 in the year 1993 to nearly 20,000 today.

Since 1978, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, the Federal Institute for Drugs and Medical Devices) gave authorization to only pharmaceutical manufacturers that provide evidence of pharmaceutical quality, efficacy, and safety of the medicinal products. After a period of 5 years, product authorization must be renewed and the renewal of authorization is granted provided that the pharmaceutical manufacturer files an application for renewal in due time and there are no objections on the new review.

Germany is also one of EU and OECD member countries, and follows the simplified regulatory approval process on Traditional herbal medicinal products under the EU Directive on Traditional Herbal Medicinal Products (THMPD) formally known as The Directive 2004/24/EC.

Contact

Federal Ministry of Health
Postal address:
First Service
Roch Strasse 1 
53123 Bonn

Second Service
Friedrichstrasse 108, 
10117 Berlin
Citizens for telephone care 
01805-99 66 03 *
Telephone citizens on health care 01805-99 66 09 *
Bundesinstitut für Arzneimittel und Medizinprodukte
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn, Germany
Telephone: +49 (0)228 99-307-0
Telefax: +49 (0)228 99-307-5207
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.