NLClinicalTrialsIMP object

Applicable national regulations

General Act(s) on Medical/Clinical Research in Humans
National Act on Medicinal Products
Transposition of (CT) Directive 2001/20/EC
Other

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

Administrative Regulation 2/2012 – Clinical trials on medicinal products (en/ unofficial translation)/ Kliiniset lääketutkimukset (fi): the Finnish Medicines Agency issued this regulation pursuant to section 15 a and 87 of the Medicines Act and section 10i of the Medical Research Act.
Regulation 2/2012 nationally implements Directive 2001/20/EC and 2005/28/EC and replaces earlier Regulation 1/2007

Transposition of (GCP) Directive 2005/28/EC

Incorporated in transposition act(s) of Directive 2001/20/EC

General legislation on Medical/ Clinical Research in Humans

Finnish Medical Research Act No. 488/1999, as amended by No 295/2004, 794/2010 (unofficial English translation)

The Act covers all medical research intervening with the inviolability of a human being, human embryo or foetus, including clinical trials on medicinal products in human subjects.

Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

Medicines Act No. 395/1987 (amendments up to 1340/2010 included, unofficial translation)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395