Central office of the federal states for health protection for drugs and medical products
Central office of the federal states for health protection for drugs and medical devices
|State level||State authority (association)|
|Supervisory authority||Ministry of Labor, Health and Social Affairs of the State of North Rhine-Westphalia (factual)|
|founding||January 2, 1994 (edict of October 11, 1993)|
|Authority management||Rainer Edelhäuser, director|
The central office of the federal states for health protection for pharmaceuticals and medical products (ZLG) is the joint authority of the 16 German federal states in the human and veterinary pharmaceutical sector, based in Bonn . It comes under the responsibility of Health Ministry of North Rhine-Westphalia and is represented by its Director. Its tasks include coordinating drug monitoring in Germany. Furthermore, it is an approving and designating authority in the field of medical devices (e.g. for laboratories).
The ZLG is the coordination office of the federal states in the human and veterinary medicinal product sector.
Drug monitoring in Germany
- System representation
- competent authorities
- Legal bases
- Quality assurance in drug monitoring and drug testing
- Committees of the supreme state authorities and their results
International cooperation in the field of drug surveillance between
- the member states of the EU
- the EU and the candidate countries
- the EU and third countries
Medical device area
The ZLG is the designating authority.
Recognition and designation requirements and procedures for
- Conformity assessment bodies that carry out tests in accordance with third country law of the USA, Canada, Australia and New Zealand
- Certification bodies for medical devices and in-vitro diagnostics
- Certification bodies for personnel
- Certification bodies for quality management systems
Sector committees and exchange of experience between the notified bodies and laboratories
Competent authorities nationally and internationally
As founding director of the ZLG, Undine Soltau ran the central office until 2012. The current director is Rainer Edelhäuser. The chairwoman of the advisory board is Dorothea Prütting.
The basis for the work of the ZLG is the agreement on the Central Office of the States for Health Protection for Medicinal Products and Medical Devices between the State of Baden-Württemberg, the Free State of Bavaria, the State of Berlin, the State of Brandenburg, the Free Hanseatic City of Bremen, the Free and Hanseatic City of Hamburg, the State of Hesse, the State of Mecklenburg-Western Pomerania, the State of Lower Saxony, the State of North Rhine-Westphalia, the State of Rhineland-Palatinate, the Saarland, the Free State of Saxony, the State of Saxony-Anhalt, the State of Schleswig-Holstein and the Free State of Thuringia from 30 June 1994.
- Website of the central office of the federal states for health protection for drugs and medical devices
- Pharmaceuticals division of the ZLG
- Medical products division of the ZLG
- Interview with founding director
- State treaty establishing the ZLG , accessed on February 21, 2014.