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) (c. 10)

ANNEX I U.K. THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP)

SECTION II U.K. GOOD LABORATORY PRACTICE PRINCIPLES

9. Reporting of study results U.K.

9.1. General U.K.

1. A final report should be prepared for each study. In the case of short-term studies, a standardised final report accompanied by a study specific extension may be prepared. U.K.

2. Reports of principal investigators or scientists involved in the study should be signed and dated by them. U.K.

3. The final report should be signed and dated by the study director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these principles of good laboratory practice should be indicated. U.K.

4. Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the study director. U.K.

5. Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report. U.K.