Language Requirement

Language Requirements for Regulatory Submissions

English is widely spoken as a foreign language, and it is commonly used in both business and science. This is particularly important for clinical trial documentation translations. Despite the use of English language, applications and trial documentation to Competent Authorities, Supervisory Authorities, and Ethics Committees, are processed in Finnish or Swedish (FIMEA notification also in English), and therefore foreign sponsors are advised to have a Finnish or Swedish speaking contact person for preparing submissions.