The BfArM and its Tasks
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of Health. The authority's seat was transferred to Bonn in the course of the Government's move to the capital. The BfArM is the successor to the Institute for Drugs (Institut für Arzneimittel) founded on 1 July 1975 as part of the now dissolved Federal Health Office (Bundesgesundheitsamt, BGA).
Today, roughly 1000 employees – including physicians, pharmacists, chemists, biologists, lawyers, engineers,technical assistants and administrative staff – work at the BfArM with the aim of preventing health risks by continuous improvement in the safety of medicinal products and by risk monitoring of medical devices as well as by monitoring the legal traffic in controlled substances scheduled in the UN-Conventions of 1961, 1971 and 1988.
For information regarding the reorganisation of licensing activities please read the following document: BfArM prepares for the future - Commentary in the RAJ (file size: 81 KB) (Important note: Unfortunately his publication does not exist in a barrier-free version)
Licensing and Registration of Medicinal Products
One of the main tasks of the BfArM is the authorisation of finished medicinal products on the basis of the German Medicines Act (Arzneimittelgesetz, AMG). In the course of these licensing procedures it reviews the proof of efficacy, safety, and adequate pharmaceutical quality of the finished medicinal products.
Licenses are limited to five years. Renewals are granted upon application and after new evaluation. The BfArM must be notified of variations to already licensed medicinal products. Major variations can only be implemented after authorisation by the BfArM.
Homoeopathic drugs are either registered by the BfArM without statement of indications or are licensed with indications. The BfArM is also involved in licensing procedures for medicinal products within the European Union.
For marketing authorisation of finished medicinal products and registration of homoeopathic medicines, reference can be made to the Pharmacopoeia in accordance with Section Act 55 of the German Medicines Act. This relieves industry as well as authorities. The Pharmacopoeia is a collection of quality requirements which is updated on an ongoing basis and which consists of the German, the European, and the Homoeopathic Pharmacopoeia. Additionally, the European Pharmacopoeia makes a major contribution towards international harmonisation of quality requirements.
Monitoring of Risks due to Medicinal Products
If a medicinal product is placed on the market and is taken by many patients after having been granted marketing authorisation, this can lead to the discovery of rare side effects not noted previously. The BfArM collects and evaluates such reports by physicians in Germany and by pharmaceutical companies. It then decides on whether the expert and patient informations of the medicinal products concerned must be altered in order to pay tribute to these risks. If the side effects recognised for a medicinal product are serious or frequent to an extent, that they exceed the benefit of the drug, the BfArM will revoke the license. In its determination, evaluation and prevention of drug-related dangers, the BfArM engages in constant exchange with other authorities of the European Union and the World Health Organisation (WHO).
Controlled Substances (Narcotics, Psychotropics, and Precursors)
The Federal Opium Agency grants licenses for participation in the legal traffic in controlled substances on the basis of the Narcotics Act (Betäubungsmittelgesetz, BtMG) including the relevant ordinances and the Regulations (EC) Nos. 273/2004, 111/2005 and 1277/2005 as well as the Precursors Monitoring Act (Grundstoffüberwachungsgesetz, GÜG).
The Federal Opium Agency controls the licence holders, monitors manufacture, handling, trade, and cultivation. It issues and distributes special prescription forms for narcotic and psychotropic drugs to the physicians. The Federal Opium Agency is the competent authority within the scope of the UN-Conventions of 1961, 1971 and 1988.
The term "medical devices" encompasses a wide range of products that are used specifically for diagnosis and prevention, treatment, or alleviation of disease or injury, for investigation or replacement of the anatomy or for wound dressings and for contraception. This also includes e.g medical-technical devices like pacemakers, X-ray units, apparatuses for radiation therapy and surgical instruments as well as in-vitro diagnostic agents, prosthetic devices, artificial teeth, and consumer articles as e.g. glasses, hearing aids, wheelchairs etc..
Should serious risks occur during use of these products they must be reported to the BfArM by manufacturers, operators, or users. The BfArM then determines the causes for these risks mainly in co-operation with the manufacturers and recommends corresponding measures for risk prevention.
Since medical devices are certified according to the Directives of the European Union they can be marketed within the whole EU if they bear a CE mark. Therefore, the BfArM co-operates with the competent authorities of the other EU Member States in all matters concerning risk prevention.