Good laboratory practice GLP

 

National legislation

Regulations on Good Laboratory Practices
Official Gazette, No. 38/2008

 

EU legislation

Directive 2004/9/EC of the European Parliament and of the Council | of 11 February 2004 | on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance) (OJ L 050, 20.2.2004)

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance) (OJ L 50, 20.2.2004)

 

Competent authority

 

Scope of application

Inspection and verification of good laboratory practice concerning the implementation of the principles of good laboratory practice and check of their use in the testing of chemical substances

 

Main requirements that the business user needs to know about

Requirements according to Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance) (OJ L 50, 20.2.2004) and Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance) (OJ L 50, 20.2.2004)

 

Market Surveillance Authority

State Inspectorate

pisarnica.dirh@dirh.hr

 

Link to the TRIS database

In the TRIS database you can look up the notification of the technical rule