Ordinance on Good Laboratory Practice (OGLP)

By Steph2
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In The Matter OfOrdinance on Good Laboratory Practice (OGLP)
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Art. 13

1 For any study that must be carried out according to the principles of GLP, it is necessary in the procedure of notification or authorisation: a. to show that the study was carried out in a test facility registered, at the time when the study was carried out, in the Swiss register of test facilities that comply with the principles of GLP; b. to present a study report in which the study director confirms, in one of the Swiss national languages or in English, that the study was carried out in compliance with the principles of GLP. 2 If the study was carried out in a country other than Switzerland, in addition to the study report, an extract from the foreign register or a confirmation from the foreign authority must be submitted proving that the test facility was included in the official monitoring programme at the time the study was carried out. In the case of countries that are not members of the Organisation for Economic Co-operation and Development (OECD), the notification authority