New language versions of part II application documents according to the Clinical Trial Regulation

The sponsor has published the updated language versions of the part II application documents according to the Clinical Trial Regulation:

in Swedish

De dokument som nämns i bilaga I till förordningen om kliniska prövningar (536/2014) och andra relevanta dokument avseende bedömningen av del II i ansökan 8.6.2022 (översättning 10.11.2022)

in English

The documents mentioned in the annex I of the Clinical Trial Regulation (536/2014) and other relevant documents regarding the assessment of the part II of the application dossier (10.11.2022)