10. The additional Member State concerned shall refuse to authorise the clinical trial if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in second subparagraph of paragraph 4, or if it finds, on duly justified grounds, that the aspects addressed in Part II of the assessment report are not complied with, or where an ethics committee has issued a negative opinion which, in accordance with the law of the additional Member State concerned, is valid for that entire additional Member State.

Make sure that any collections of samples or test pieces demonstrating non-conformity with the type test under consideration is followed by a subsequent sampling and a further test.

Make sure that any collections of samples or test pieces demonstrating non-conformity with the type test under consideration is followed by a subsequent sampling and a further test.

Where a test sample fails a particular test to which it has been subjected, a further test to the same requirement shall be carried out on at least three other samples.

1.1.6. take steps to ensure that any taking of samples or test-pieces which give evidence of non-conformity for the type of test under consideration is followed by a fresh taking of samples and a new test.

5.2.5. ensure that any sampling of engines or components giving evidence of non-conformity with the type of test considered shall give rise to another sampling and another test.