Legislation governing the conduct of clinical trials on medicinal products in accordance with Directive 2001/20/EC

International documents

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

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

Laws

Law on Ethics of Biomedical Reseach of the Republic of Lithuania

Law on Pharmacy of the Republic of Lithuania

Goverment resolution

Resolution of the Government of the Republic of Lithuania "On the Approval of the List of Specific Amounts of the State Fee and the Rules for the Payment"

Decrees of the Ministry of Health (MOH)

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) 

Decree on the Rules of Good Clinical Practise

Decree on the Detailed Requirements for the Content of a Person’s 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

Orders and guidelines of the Lithuanian Bioethics Committee

Order on the Sample Form of the Biomedical Research Protocol, Summary of the Protocol of the CV of Investigator

Guidelines for Patient Information Sheet and Informed Consent Form, adopted by the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee

Guidelines to advertise clinical trials, adopted by the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee on 15 May 2007