Clinical trials
Clinical trials of medicinal products are an important part of the medicinal product development process, enabling the safety and efficacy of investigational medicinal products in humans to be assessed.
In the European Union (EU), the conduct of clinical trials of medicinal products is governed by Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (hereinafter – the Regulation), which became applicable on 31 January 2022. The Regulation establishes harmonised rules for the submission and assessment of clinical trial applications, authorisation, conduct and supervision of clinical trials in the EU and European Economic Area (EEA) countries. As of 31 January 2025, all ongoing clinical trials in the EU and EEA must comply with the requirements of the Regulation.
State fee for issuing authorisation of a clinical trial on medicinal products
In order to obtain authorisation of a clinical trial on medicinal products, the payment order should be submitted together with the other documents to SMCA.
The amounts of state fees are approved by Resolution No 1458 of the Government of the Republic of Lithuania of 15 December 2000 “On the Approval of the List of Specific Amounts of State Fees and the Rules for the Payment and Refund of State Fees”.
The state fee shall be paid to Vilnius District State Tax Inspectorate.
Beneficiary: Vilnius District State Tax Inspectorate (Reg. No. 188659752)
Payments can be made to these accounts: Sąskaitos ir įmokų kodai - VMI
Accounts No. | Bank code | Name of bank | SWIFT code |
LT24 7300 0101 1239 4300 | 73000 | „Swedbank" AB | HABALT22 |
LT32 7180 0000 0014 1038 | 71800 | AB „Artea“ bankas | CBSBLT26 |
LT05 7044 0600 0788 7175 | 70440 | AB SEB bankas | CBVILT2X |
LT78 7290 0000 0013 0151 | 72900 | AS „Citadele banka“ Lietuvos filialas | INDULT2X |
LT08 4040 0636 1000 3117 | 40400 | MFRLLT22 | |
LT74 4010 0510 0132 4763 | 40100 | Luminor Bank AS Lietuvos skyrius | AGBLLT2X |
LT42 7230 0000 0012 0025 | 72300 | UAB Urbo bankas | MDBALT22 |
Payment code: 5750
When paying fees please ensure that, the relevant protocol No or EUCT No is stated on your bank’s advice note.
Publishing of the Results of Clinical Trials:
One of the key objectives of the Regulation is to ensure the transparency of clinical trial data. Therefore, clinical trial sponsors are required to submit the results of completed clinical trials in CTIS in a timely manner: within one year of the end of the clinical trial in the EU, or within six months where the clinical trial involves paediatric patients.
Other important information
Ongoing clinical trials in Lithuania
Last updated: 11-08-2026