CTIS Submissions in Latvia, Lithuania and Poland: What Sponsors Should Prepare

Latvia, Lithuania and Poland are EU member states, so clinical trials of medicinal products are submitted through the Clinical Trials Information System (CTIS) under Regulation (EU) No 536/2014.

How the process is organised

The sponsor submits one application dossier through CTIS to all concerned member states.
Part I covers the scientific and investigational product aspects and is assessed jointly by the concerned member states.
Part II covers national aspects such as subject information and consent, sites, investigators and insurance, and is assessed by each country.
Authorities and ethics bodies can send requests for information, and the sponsor must answer within the set deadlines.

What to prepare early

Complete and consistent Part I documents, because inconsistencies between documents are a common source of questions.
National Part II documents and translations of subject-facing material into the local languages.
Site and investigator information for each country, ready when the dossier is submitted.
A named person who can answer questions quickly during the assessment.

Where a CRO helps

Preparing and checking the dossier and tracking each country in CTIS.
Coordinating answers to requests for information so that deadlines are met.
Aligning submission timing with site contracts and investigational product supply.

Medical devices and other study types

Studies that are not clinical trials of medicinal products follow national procedures, and the route depends on the product and study design. Confirm it during feasibility.

Discuss your study

Share your protocol synopsis and target countries, and we will respond with a feasibility view.

Request a proposal Contact us