Ordinance on Good Laboratory Practice (OGLP)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 14 Register and GLP list
1 The notification authority shall maintain a register of all establishments with their inspected test facilities and their audited studies. 2 The notification authority shall enter the data in the register as soon as the formal decision has been made confirming conformity of the test facility with the principles of GLP. 3 The notification authority shall provide the establishment with a confirmation stating, in one of the official Swiss languages or in English, that its test facilities are listed in the register. 4 The notification authority shall regularly publish, in an appropriate way, a list of the test facilities that work according to the principles of GLP. 5 If the principles of GLP are no longer respected, the test facility shall be removed from the list mentioned in paragraph 4.
Art. 15 Content of the register
The register shall specify: a. the name and address of the establishment and of its test facilities; b. the type and date of inspection and the relevant areas of expertise; c. the date of the study audit and identification of the study; d. the decision relative to compliance with GLP Principles; e. the date of the decision or of the notification that the relevant test facility no longer complies with GLP Principles.
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.
Art. 17 Confidentiality of data
1 The competent authorities may transmit confidential data only to: a. each other; b. the federal executive authorities pursuant to Article 16 paragraph 2; c. foreign GLP authorities, if this is provided for by agreements under international law or by federal legislation. 2 Under no circumstances are the entries in the register pursuant to Article 15 confidential.
Art. 18 Dealings with foreign authorities
1 Depending on the area of competence (Art. 8), the FOPH, the FOEN and Swissmedic shall represent Switzerland on GLP-related issues in dealings with authorities and institutions abroad, and with international organisations. 2 The FOEN shall co-ordinate dealings with the Organisation for Economic Co-operation and Development (OECD) at national level. Each year it shall supply the OECD and the OECD member states with a list of inspected establishments with their test facilities and conducted study audits, and notify them of establishments that are guilty of serious non-compliance with GLP Principles.