Germany Publishes English Translation of Standard Contractual Clauses Ordinance

The German Federal Ministry of Health (BMG) has published an English translation of the Standard Contractual Clauses Ordinance (Standardvertragsklauselverordnung – StandVKlV) on its website. The ordinance forms part of the broader “Regulation on the Simplification of the Conduct and Approval of Clinical Trials” (Verordnung zur Vereinfachung der Durchführung und Genehmigung klinischer Prüfungen), which was published in the Federal Law Gazette on 18 September 2025.

The StandVKlV applies to contracts concluded from 17 December 2025 onwards. The English translation is intended solely to help non-German-speaking stakeholders understand the rules. The BMG emphasizes that only the original German text is legally binding. Any discrepancies between the translation and the German version have no legal effect and do not affect compliance obligations.

Stakeholders conducting clinical trials or entering related contracts are advised to refer to the official German text to ensure legal compliance. Additional information is available on the BMG website.

25-11-2025