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Eurecnet - Legislation: Lithuania

Legislation: Lithuania

    I. International documents legally binding in Lithuania

    • Directive 2001/20/EC of the European parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
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    • Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
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    • Convention of the Council of Europe 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
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    II. Legal acts applicable to all types of biomedical research

      a) Laws

    • Law on Ethics of Biomedical Research (2001, last amended in 2016) (available in English)
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    • Law on Legal Protection of Personal Data (1996, last amended in 2017) (available only in Lithuanian)
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    • b) Decrees of the Ministry of Health

    • Decree on the Detailed Requirements for the Content of a Personís Consent to Participate in Biomedical Research and for the Information about the Biomedical Research as well as a Procedure for Giving and Withdrawing the Consent, No. V-28 (2016) (available only in Lithuanian)
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    • Decree on the Procedure for Calculating and Paying Compensation for the Expenses Incurred Due to Participation in Biomedical Research and the Time Spent, No. V-15(2016) (available only in Lithuanian)
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    • Decree on the Rules of Compulsory Civil Liability Insurance for the Principal Investigator and the Sponsor No. 745 (2000, last amended in 2016) (available only in Lithuanian)
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    • Decree on the List of Interventional Methods of Biomedical Research Causing a Slightly Detrimental and Temporary Impact on the Subjectís Health, No. V-1483 (2014) (available only in Lithuanian)
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    • Decree of MOH and Ministry of Social Affairs on the Procedure for a Minorís Participation in Biomedical Research, No. V-235/A1-83(2016) (available only in Lithuanian)
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    • Decree on the Procedure for Keeping a Record of Biomedical Research, Collecting, Storage and Providing Information on Biomedical Research, No. V-405 (2010) (available only in Lithuanian)
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    • Decree on the Statute of the Lithuanian Bioethics Committee No. V-895 (2009) (available only in Lithuanian)
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    • Decree on the Appointment of the Biomedical and Social Sciences or Humanities Specialists for theGroup of Experts on Biomedical Research of the Lithuanian Bioethics Committee No. V-1185 (2014) (available only in Lithuanian)
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    • Decree on the Composition of the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee, No. V-1348 (2018) (available only in Lithuanian)
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    • Decree on the Activities and Reimbursement of the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee No. V-11 (2015) (available only in Lithuanian)
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    • Decree on the Territories Assigned to the Jurisdiction of the Regional Biomedical Research Ethics Committees, No. V-1078 (2007) (available only in Lithuanian)
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    • c) Orders and guidelines of the Lithuanian Bioethics Committee

    • Order on the Procedure for Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favourable Opinion to Conduct a Clinical Trial on Medicinal Products or Approval to Conduct Biomedical Research by the Sponsor of the Clinical Trial on Medicinal Product or Other Type of Biomedical Research, No. V-24 (2014) (available only in Lithuanian)
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    • Order on the Sample Form of the Biomedical Research Protocol, Summary of the Protocol of the CV of Investigator, No. V-7 (2016) (available only in Lithuanian)
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    • Order on the Sample Forms of the Documents Issued by the Lithuanian Bioethics Committee, No. V-10 (2011) (available only in Lithuanian)
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    • Order on the Procedure of Ethical Supervision of Conduct of Biomedical Research, No. V-19 (2012) (available only in Lithuanian)
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    • Guidelines for Patient Information Sheet and Informed Consent Form, adopted by the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee (2016) (available only in Lithuanian)
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    III. Legal acts that specifically cover clinical trials on medicinal products

      a) Laws

    • Law on Pharmacy (2006, last amended in 2017) (available only in Lithuanian)
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    • b) Decrees of the Ministry of Health

    • Decree on the Procedure for Issuing Favourable Opinion to Conduct Clinical Trial on Medicinal Product, Approval for Clinical Trial on Medicinal Product, Conducting and Controlling Clinical Trials, No. 435 (2006) (available only in Lithuanian)
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    • Decree on the Rules of Good Clinical Practice, No. 320 (2006) (available only in Lithuanian)
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    • c) Orders and guidelines of the Lithuanian Bioethics Committee

    • Order on the Sample Form of the Request to Issue Favourable Opinion to Conduct Clinical Trial on Medicinal Product Form and the Ethical Assessment Form, No. V-6 (2016) (available only in Lithuanian)
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    • Guidelines to advertise clinical trials, adopted by the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee on 15 May 2007 (available only in Lithuanian)
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    IV. Legal acts that cover other biomedical research

      a) Decrees of the Ministry of Health

    • Decree on the Procedure to Issue Approvals to Conduct Biomedical Research, No. V-2 (2008) (available only in Lithuanian)
      click here to view

    • b) Orders and guidelines of the Lithuanian Bioethics Committee

    • Order on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical Research Ethical Assessment Form, No. V-4 (2016) (available only in Lithuanian)
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    • Order on the Sample Form of the Summary Report of Biomedical Research, No. V-6(2014)(available only in Lithuanian)
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