Legislation governing the conduct of clinical trials on medicinal products in accordance with the requirements of Regulation (EU) No 536/2014

International documents

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Laws

Law on Ethics of Biomedical Reseach 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 exemplary regulations of the Medical Ethics Commission of a Personal Health Care Institution

Decree on the procedure for the organization of Good Clinical Practice trainings and the requirements for the development of these training programs

Last updated: 30-08-2023