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.