Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten

medicinal products

Which services are provided by ZLG in the field of medicinal products?

Quality Management SystemProject management and conceptual work on the Laender quality management system in the area of drug supervision and testing regarding medicinal products for both human and veterinary use

Expert Groups
Co-ordination and project management for the operation of the 14 expert groups

Co-ordination of Laender activities related to the equivalency evaluation in the framework of the existing Mutual Recognition Agreements (MRA) between the EC and Australia, Japan, Canada, New Zealand, Switzerland, USA

Support of the work of the Laender board of the AOLG for medicinal products, pharmacies, transfusion medicine and narcotic substances (AATB) and the Laender board of the ArgeVet for veterinary medicinal products (AG TAM)

Participation as a member in European commitees (Ad Hoc Working Group of GMP Inspection Services at the EMEA in London) and participation in European objectives (e.g. assessment of third countries)

EMEA Inspections
Coordination of inspections under the centralised procedure according to regulation 2309/93/EC in case of German participation

EDQM Sampling
Coordination and national contact point for sampling of centrally authorised medicinal products to be taken from the German market upon request of EDQM for testing through the European OMCL network

National GMP Contact Point
Exchange of information on manufacturers between the German Laender and the other EC/EEA Member States, MRA partner countries and in the framework of PIC

Co-ordination in the field of the Official Medicines Control Laboratories

General Reporting / Statistics
Review of the Laender annual reports on drug supervision and testing

Co-ordination of trainings (specific professional trainings; annual pharmaceutical conference of the German Laender; PIC/S seminars)

Veterinary Medicinal Products
Special co-ordination in the area of veterinary medicinal products

Drug Safety
Co-ordination in the area of drug safety in case no Laender authority is locally responsible

Information / General Support
Information and general support of the Laender authorities operating in the field of medicinal products on activities of national and international committees