Division D The applicant shall, in addition to the information required under Sections A, B and C provide the following information regarding the testing:

participating laboratories, time of the analysis and outline of the experimental design, including the details about the number of runs, samples, replicates, etc.;

description of the laboratory samples (such as size, quality, date of sampling), positive and negative controls as well as certified reference material, plasmids and alike used;

description of the approaches that have been used to analyse the test results and outliers;

any particular points observed during the testing;

references to relevant literature or technical provisions used in the testing.