Austria

Policy

There is no plan to develop any national policy, laws, programs or related regulations regarding TM/CAM.  There are no national institutes in charge of research and no expert committees have been established to develop any plans. However, the Austrian Medical Association in November 2000 granted anthroposophic medicine recognition as a method of complementary medicine (following numerous interventions by the Working Group of Anthroposophic Physicians in Austria) with the diploma of the Austrian Medical Association for complementary medicine. The Austrian Biodiversity Strategy was developed in 1998 in line with the requirement of Convention on Biological Diversity (CBD), this Strategy set out the general policy directions in regards to the conservation and sustainable use of biological diversity. The Advanced Austrian Implementation Strategy for the CBD in 2005 revamped the Austrian Biodiversity Strategy to include reviews and updates in line with the latest development of CBD. Austrian has 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 

BMSG - Ministry of Social Security and Generations
Abt. VIII/A/22- Medical
Devices/Medizinprodukte,
Radetzkystrasse 2, A-1031
 

Laws and Regulations

Products falling into the Food Supplement Category are required to be approved as “Verzehrprodukte” by the Ministry of Social Security and Generations, (BMSG).  All products are evaluated by the pharmaceutical division before being sent to the food unit. In Austria, herbal medicines are regulated as prescription and medical claims may be made by law.

Since there is no official list of herbal products that fall into the Verzehrprodukte category, each product is evaluated on a case-by-case basis by the BMSG.  Determinations are based upon the ingredients, presentations and claims.  There are some botanicals that may be used under a simplified pharmaceutical application.  Both the Austrian pharmacopoeia and the European pharmacopoeia are legally binding.

Addition of any ingredient for the purpose of enhancement or fortification is regulated by the BMSG and approved on a case-by-case basis.  The addition of herbal extracts is currently not covered under existing regulations.

There is no post-market surveillance system in place.

There is no plan to develop any national policy, laws, programs or related regulations regarding TM/CAM and there are no expert committees on TM/CAM or herbal medicines.

Contact 

BMSG - Ministry of Social Security and Generations 
http://www.bmsg.gv.at/cms/siteEN/index.html

 

Standards & Guidelines

In Austria, there are several cornerstones of traditional herbal medicines; at least 30 years of medical use (including at least 15 years in the EU). The application of traditional herbal medicines is possible without medical supervision. The quality of products must meet the current guidelines, and one of the guidelines is The Guidelines for Good Agricultural and Wildlife Collection Practice (GACP).

The Federal Office for Safety in Health Care, BASG is the competent authority which approves drugs related to traditional herbal medicine.

Austria 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 

BMSG - Ministry of Social Security and Generations
Website: http://www.bmsg.gv.at/cms/siteEN/index.html

Address: Federal Ministry of Labour, Social Affairs and Consumer Protection 
Stubenring 1 
1010 Vienna
Telephone: +43 (1) 711 00-0
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.