Eurecnet - Legislation: Lithuania

Legislation: Lithuania

I. General legal acts

Law on the Health System
• Law on the Health System, 1994
  english

Privacy/Data Protection
• Law on Legal Protection of Personal Data, No. IX-1296 (2004):
  english



II. Legal acts on Biomedical Research (excluding clinical trials on Medicinal Products):

• Law on Ethics of Biomedical Research, No. VIII-1679 (2007)
  english


Ministry of health (MOH):
• 1. Decree on the Procedure to Issue Approvals to Conduct Biomedical Research, No. 570 (2000)
  english


• 2. Decree on the Procedure for the Estimation and Covering of Expenses Incurred by Research Subjects, No. 23 (2000)
  lithuanian


• 3. Decree on the Rules of Compulsory Civil Liability Insurance for the Principal Investigator and the Sponsor No. 745 (2000)
  lithuanian


• 4. Decree on the List of the Documents to be Presented by the Sponsor of Biomedical Research and (or) by the Principal Investigator in Order to be Authorized to Conduct Biomedical Research, No. 29 (2001)
  english


Lithuanian Bioethics Committee (LBEC):
• 1. Decree on the Requirements for the Form and Content of documents to be Presented by the Sponsor of Medical Research and (or) by the Principal investigator in Order to be Authorized to Conduct Biomedical Trial No. 09-22 (2001)
  english


• 2. Decree on the List of Documents to be Presented by the Sponsor of Medical Research and (or) by the Principal Investigator in Order to be Authorized to Conduct Biomedical Trial No. V-21 (2004)
  english





III. Legal acts dealing with Clinical Trials on Medicinal Products:

• Law on Pharmacy, No. X-709 (2006)
  lithuanian


State Medicines Control Agency (SMCA):
• 1. Decree on Pediatric Clinical Trials No. 70 (2002) (available only in Lithuanian)
  lithuanian
• 2. Detailed Guidance for the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Notification of Substantial Amendments and Declaration of the End of the Trial (2006)
  english
• 3. Decree on the Requirements for Reporting Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (ADRs) from Clinical Trials (CTs) No. 1A-633 (2006)
  english


Lithuanian Bioethics Committee (LBEC):
• Decree on the Regulation for the Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favourable Opinion to Conduct a Clinical Trial on Medicinal Products No. V-11 (2004)
  english


Ministry of health (MOH):
• Health Care Ministry Decree on the Procedure to Issue Approvals to Conduct Clinical Trial on Medicinal Product, No. V-435 (2006) (available only in Lithuanian)
  lithuanian





IV. Legal acts on Cloning, Stem Cell and Embryonic Research

• 1. Law on Ethics of Biomedical Research, No. VIII-1679, Article 3 (2000):
  english
• 2. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings No. IX-1085 (2002):
  english


Ministry of health (MOH):
• Decree on the Procedure to Issue Authorization for the Transit of Tissues of Human Embryonic Tissue, Embryonic Stem Cells and their Lines, Fetal Tissue and Fetal Stem Cells throughout the Territory of the Republic of Lithuania, No. V-660 (2007) (available only in Lithuanian)
  lithuanian

<- Legislation

Contact: eurec@eurecnet.org