Clinical Trials: BMG publishes Standard Contractual Clauses Ordinance

The 'Regulation on the Simplification of the Conduct and Approval of Clinical Trials' (Verordnung zur Vereinfachung der Durchführung und Genehmigung klinischer Prüfungen) was published in the Federal Law Gazette on 18 September 2025. Among other things, it contains the Standard Contractual Clauses Ordinance (Standardvertragsklauselverordnung - StandVKlV), which applies to contracts concluded after 17 December 2025.

An English translation of the Standardvertragsklauselverordnung (StandVKlV) - the Standard Contractual Clauses Ordinance - has now been published on the website of the German Federal Ministry of Health (BMG). However, the BMG points out that this translation is intended solely to aid comprehension for non-German-speaking recipients. In case of doubt, the German version is authoritative and legally binding. Deviations in the translation are non-binding and therefore have no legal effect for compliance or enforcement purposes.

More information can be found on the BMG website.