The following Acts, Regulations and Guidelines apply to clinical trials.

Act

• The Medicinal Products Act No. 93/1994

Regulations

• Regulation No. 443/2004 on clinical trials of medicinal products in humans
• Regulation No. 893/2004 on manufacturing of medicines

Eudralex Volume 10, Clinical Trials

GMP Volume 4: Manufacture of Investigational Medicinal Products

Directive 2001/20/EC

ICH-GCP Guideline on good clinical practice

Helsinki Declaration

Ethical Principles for Medical Research Involving Human Subjects