All approvals of the Local Ethics Committees (LECs) in charge of the trial sites must be obtained prior to regulatory submission. Depending on the type of LEC and whether the deadlines for submission are met, it may take up to six weeks. Ethics Committees are either established in hospitals or by the Chamber of Physicians.

The regulatory process takes approx. 60 days for all phases (period not exactly determined by law) and includes an ethical evaluation. Any objections or requests for more information may prolong the approval process. The applicant must be a legal entity registered in Slovakia or in the Czech Republic, no submission is accepted by foreign companies without local affiliation.

International standard patient insurance is acknowledged.

Customs clearance is granted upon demand for a direct supply of the trial sites, separately for each shipment.

Overall approval time is 90 days min. for all phases.

Health care system

Depending on specialisation, the degree of privatisation ranges from 20% to 80% and a major part of outpatients could still be found centrally in hospitals.

Infrastructure

Communication facilities comparable to Western Europe.

Small country, highway access to major towns, highway to Czech Republic. No fast inter-city train system available. From Bratislava direct flights to several European capitals as well as a few national flights. Vienna (international airport) about 1 hour by car/ shuttle bus.

Local office/staff

Business in Slovakia is run by the CEE headquarters located in Prague and by the national study co-ordinator based in Bratislava
ECRON - The Czech Expert s.r.o., Na Prikope 15, 11000 Prague 1,
Czech Republic
Email bd@ecronacunova.com

Links

EU enlargement pages
Authority: State Institute for Drug Control "SUKL"