Ordinance on Good Laboratory Practice (OGLP)

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In The Matter OfOrdinance on Good Laboratory Practice (OGLP)
Exhibit A
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Ordinance on Good Laboratory Practice (OGLP)

SR 813.112.1 — Ordinance of 18 May 2005 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. English consolidation of 1 December 2012, which is also the date of the current binding text.

Preamble

The Federal Council based on Article 5 paragraph 2 letter a of the Chemicals Act of 15 December 2000 (ChemA),Articles 26 paragraph 3, 38 paragraph 3 and 39 paragraph 1 of the Environmental Protection Act of 7 October 1983 (EPA) and Article 11 paragraph 2 letter a of the Federal Act of 15 December 2000 on Therapeutic Products (TPA) decrees:

SR 813.1 SR 814.01 SR 812.21

Contents

1. General Provisions — 3 articles 2. GLP Principles and Compliance Monitoring — 9 articles 3. Documentation and Conformity with GLP Principles — 1 article 4. Other Regulations — 5 articles 5. Final Provisions — 2 articles