Regulations and Guidelines
The directives, laws, decrees and regulations followed in Finland are listed below. Please note that all amendments of national laws may not have been translated into English, and the laws may have been amended after publication of the English translation (marked with *). The amendment numbers in parentheses means the last amendment that has been included in the unofficial translation. The national laws are legally binding only in Finnish and Swedish. Current and valid legislation is available at Finlex website. Current relevant EU legislation: see EudraLex volume 1.
National Legislation (Finland, abbreviated names):
- Act on Clinical Trials on Medicinal Products (938/2021)
- Decree of the Ministry of Social Affairs and Health on Remuneration Payable to Research Subjects (82/2011)
- Biobank Act (688/2012*)
- Act on the Status and Rights of Patients (785/1992*)
- Medicines Act (395/1987 and amendments up to 1340/2010*)
- Child Welfare Act (417/2007 and amendments up to 1292/2013*)
- The Constitution of Finland (731/1999 and amendments up to 817/2018)
- Child Custody Act (361/1983 and amendments up to 352/2019)
- Data Protection Act (1050/2018)
- Act on the Openness of Government Activities (621/1999 and amendments up to 907/2015*)
- Act of the Medical Use of Human Organs, Tissues and Cells (101/2001 and amendments up to 277/2013*)
- Gene Technology Act (377/1995 and amendments up to 955/2010*)
- Gene Technology Decree (928/2004)
- Fimea Administrative Regulation: Clinical Trials on Medicinal Products (8/2019)
- Secondary use of health and social data (552/2019, only in Finnish and Swedish; no English translation available. Short English summary at the Ministry of Social Affairs and Health website: https://stm.fi/en/secondary-use-of-health-and-social-data)
- Criminal Code (39/1889)
EU directives, regulations and guidelines:
- EU Clinical Trial Directive (2001/20/EC)
- EU Medicinal Product Directive (2001/83/EC) and Amendment (2003/63/EC)
- EU Investigational Medicinal Product Directive (2005/28/EC)
- EU Pediatric Regulation (EC 1901/2006) and Amendment (EC 1902/2006)
- EU Clinical Trials Regulation (EU 536/2014)
EMA guideline on conduct of pharmacovigilance for medicines used by the paediatric population
Ethics:
- World Medical Association Declaration of Helsinki (2013)
- Operating Procedures of the National Committee on Medicinal Research Ethics (TUKIJA) (Jan 2019)
- The National Committee on Medicinal Research Ethics – Report on Pediatric Research (2003)
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E6 for Good Clinical Practice
- Revision 1 (ICH E6(R1) step 5 (135/1995)
- Revision 2 (ICH E6(R2) step 5 (2016)
- EU Commission’s Guideline on Ethics for Pediatric Trials, Revision 1 (2017)
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E11 for Clinical Trials of Paediatric Population
- United Nations Convention of the Rights of the Child (1989)
- United Nations Universal Declaration of Human Rights (1948)
- Council of Europe Convention on Human Rights and Biomedicine ETS 164 (1997)