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Art. 16 Notification in cases of serious non-compliance with GLP Principles
1 If in the course of an inspection, the competent authority ascertains that a test facility fails to comply with GLP Principles to the extent that the reliability of study results is no longer guaranteed, and that in consequence these results may generate erroneous conclusions relating to human and environmental safety, it must immediately inform the notification authority. 2 The notification authority must inform the federal executive authorities responsible for evaluating notifications or authorisations for substances and preparations. |
