Good Laboratory Practice - GLP
- Directive 2004/9/EC lays down the obligation of the Member States to designate the authorities responsible for GLP inspections in their territory. It also comprises reporting and internal market (= mutual acceptance of data) requirements. The Directive requires that the OECD Revised Guides for Compliance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits. Directive 2004/9/EC has replaced Directive 88/320/EEC as of 11 March 2004.
- Directive 2004/10/EC requires Member States to take all measures necessary to ensure that laboratories carrying out safety studies on chemical products comply with the OECD Principles of Good Laboratory Practice. Directive 2004/10/EC replaces Directive 87/18/EEC.
Mutual acceptance of data
The European Union has concluded Mutual Recognition Agreements in the area of GLP with Israel, Japan and Switzerland . By means of the Treaty of the European Economic Area (EEA) of 13 December 1993, the European Regulations and Directives also apply to Iceland, Liechtenstein and Norway.
In addition, following Decision C(97)186/Final of the OECD Council, data generated in the testing of chemicals in an OECD Member Country, in accordance with OECD Test Guidelines and the Principles of Good Laboratory Practice, are accepted in other OECD Member Countries (e.g. Australia, Canada, Korea and USA).
Product oriented legal acts
- Classification, labelling and packaging of chemical substances and mixtures
- Feeding stuffs
- Medicinal products
- Novel Foods (NF)
- Veterinary products
- Implementation of the GLP Directives in the European states
- Inspected test facilities
- Guidance Documents For GLP Inspectors And GLP Test facilities: Cross-contamination [62 KB]
Guidance (questions & answers)
- Questions & Answers [291 KB]