At least one approval by the Local Ethics Committees (LECs) in charge of the trial sites must be obtained before regulatory submission. The regulatory approval won’t be granted until the other LEC votes have been obtained. Depending on the type of LEC and whether the deadlines for submission are met, the LEC approval may take from one to four weeks.

The regulatory process takes 30 to 60 days. Any objections or requests for more information may prolong the approval process.

The patient insurance must be concluded with an insurance company based in Poland, or with an international insurance running a Polish affiliate office. If this request is not met, an add-on insurance can be concluded easily.

Customs clearance is granted with the authorities’ approval, either to the applicant or for a direct import to the sites (single or multiple shipment of the cleared total amount).

Overall approval time is 60 days for all phases, plus the period of the preceding approval of the fastest LEC.

Health care system

The degree of privatisation in the medical sector is lower than e.g. in the Czech Republic and may range up to 30 %. Therefore, a major part of outpatients could be recruited in the respective hospitals’ departments.

Infrastructure

Communication facilities comparable to Western Europe.

Large country, nearly no highways between major towns, no fast inter-city train system available (except for the axis Berlin- Poznan- Warsaw), national flights rare and expensive.

Local office/staff

ECRON Sp. z o. o., ul. Rejtana 17/25, 02-516 WARSAW, Poland
Email: bd@ecronacunova.com

Links

EU enlargement pages
Drugs registered in PL (downloadable ZIP or XLS files)