Applications under the Directive

Clinical trials applications under the Medicinal Research Directive

The processing of new trials under the Directive has ended on 31.1.2023.

During the transitional period 31.1.2023-31.1.2025, Tukija's meetings will consider applications submitted in accordance with the Medicines Research Regulation (536/2014) and the Medicines Research Directive (2001/20/EC). Only Substantial Amendments under the the Directive will be considered.

Substantial Amendments under the Directive are submitted via Tukija's e-service. The forms only work with Chrome or Firefox browsers. The forms are only available in Finnish and Swedish.

The system sends an automatic reply when the documents arrive. Make sure you have received this confirmation. Otherwise, please contact at info(at)tukija.fi. Please note that the maximum combined size of the attachments is 45MB, but we recommend a smaller combined size.

Operating Procedures 8.4.2022 (Directive)

Data protection roadmap for scientific research (Office of the data protection ombudsman)

Instructions On Reporting Financial and Other Arrangements Related to Clinical Trials (28.12.2022)

Lausuntohakemus kliinisen lääketutkimuksen merkittävästä muutoksesta (Only in Finnish)

Ilmoitus kliinisen lääketutkimuksen päättymisestä (Only in Finnish)

Kliinisen lääketutkimuksen merkittävää muutosta koskevan lausuntohakemuslomakkeen täyttöohje (Only in Finnish)

Tutkimuksen päättymisilmoituksen täyttöohje (Only in Finnish)