Legislation

This page brings together the legislation applicable to the activities of Tukija.

Clinical trials

Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products (EU) (536/2014)

Act on Clinical Trials on Medicinal Products (983/2021)

Act of the Medical Use of Human Organs and Tissues (101/2001)

Decree of the Ministry of Social Affairs and Health on fees charged for opinions of the national medical research ethics committee (34/2025) (in Finnish)

Act on the National Institute for Health and Welfare

Research on medical devices (as part of clinical trials)

Medical Devices Act (719/2021)

MD-Regulation Regulation of the European Parliament and of the Council (EU) 2017/745

IVD-Regulation Regulation of the European Parliament and of the Council (EU) 2017/746

Biobanks

Biobank Act (688/2012)

Decree of the Ministry of Social Affairs and Health on the notification of the biobank (in Finnish)

Act on the Medical Use of Human Organs, Tissues and Cells (101/2001)

Other applicable national legislation

Medical Research Act (488/1999)

Act on the Status and Rights of Patients (785/1992)

Data protection Act (1050/2018)

Administrative Procedure Act (434/2003)

Act on the Openness of Government Activities (621/1999)

Act on Electronic Services and Communication in the Public Sector (13/2003)

Medicines Act (395/1987)

Criminal Code of Finland (39/1889)

EU-legislation

Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products (EU) N:o 536/2014

MD-Regulation Regulation of the European Parliament and of the Council (EU) 2017/745

IVD-Regulation Regulation of the European Parliament and of the Council (EU) 2017/746

General Data Protection Regulation (GDPR) Regulation of the European Parliament and of the Council (EU) 2016/679

International guidelines and recommendations

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. Convention on Human Rights and Biomedicine. Council of Europe. European Treaty Series 164 (1997)

Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS no. 195)

International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organization of Medical Sciences)