Clinical trials

According to the Law on Pharmacy, clinical trials of a medicinal products for human use may be conducted only having the favorable opinion of the Lithuanian Bioethics Committee and the authorisation of the State Medicines Control Agency (SMCA). The procedure for submission of clinical trial application (CTA) and issuing authorisation of a clinical trial on medicinal products is established by the order of the Minister of Health.

The national legislation for the submission and authorisation procedures of CTAs conforms the current Directive 2001/20/EC and EU guidance documents (i.e. CT-1 document, see Eudralex volume 10).

How to submit the clinical trial application to the Lithuanian SMCA?

In order to simplify the submission process of applications for clinical trials on medicinal products and to waive the submission of paper documents, SMCA is accepting all documentation related to clinical trial applications in an electronic file format.

Sponsors and applicants of clinical trials are encouraged to submit applications and all related documentation through the Common European Submission Platform ("CESP"). CESP is a portal for the submission of applications within the EU. Information regarding the submission of applications via the CESP portal, including ensuring access to the portal, is available on the HMA website.

All documents are accepted in English (except patients related documents and protocol summary in Lithuanian language).

There are few additional requirements:

- CVs and GCP learning certificates should be submitted for all investigators together with the list of all trial sites and investigators per site;

- there is a need for insurance according to the Order of Minister of Health;

- signed tripartite agreement between Sponsor, Head of trial site and Principal investigator;

- fee should be paid in advance.

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 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: https://www.vmi.lt/evmi/en/saskaitos-ir-imoku-kodai

A fee for issuing authorisation of a clinical trial on medicinal products – 950 €.

Payment code: 5750

When paying fees please ensure that, the relevant protocol No or EudraCT No is stated on your bank’s advice note.

Procedure to issue authorisation of a clinical trial on medicinal products

A decision about the authorisation of a clinical trial on medicinal products is made at the meeting of The Scientific Board. Meetings of The Scientific Board are held once a month.

Authorisation of a clinical trial on medicinal products shall be issued or a reasoned refusal to grant it shall be given within 60 calendar days from the registration of the valid application.

It is important to note that the authorisation of a clinical trial on medicinal products will be issued only after the receipt of the favorable opinion of the Lithuanian bioethics committee.

How to find out if a clinical trial has been authorised?

The authorisation for clinical trials at each trial centre is issued by the Order of the Head of the SMCA. An English translation of the Order together with the list of clinical trials and trial centres is provided on our website.

A clinical trial may be initiated after the appropriate Order of the Head of the SMCA is published.

Following a separate request from the sponsor, the authorisation for a clinical trial of the medicinal product may be printed using the specific form approved by the Order of the Head of SMCA.

In case any questions, please contact the Marketing Authorisation Unit.

Other important information

Ongoing clinical trials in Lithuania (only in Lithuanian 2023-01-11)

Schedule of GCP inspections (only in Lithuanian)