An update of Tukija's guidelines " The documents mentioned in the Annex I of the EU Clinical Trials Regulation (536/2014) and other relevant documents regarding the assessment of part II of the application dossier" will be published in early May. The update concerns, among other things, the submission of so-called patient facing documents. This and other updates to the guidelines are mainly technical in nature.
According to section 1.24 of the updated Q&A guidelines published by the EU Commission on 27 March 2026, any translations of forms intended for the subject should be placed in Part II of the application. However, Tukija will not require the submission of translations separately in the future. The patient facing documents (other than recruitment material or subject information sheets) shall be submitted in Part I of the application in Finnish, Swedish or English (generally in accordance with the language used in the protocol). In this respect, Tukija's instructions will not change.
Read more: Questions and Answers Document - Regulation (EU) 536/2014 (27th March 2026, European Commission)
