Clinical trials of medicinal products are subject to the provisions of Act No. 44/2014, on scientific research in the health sector, and are in addition subject to the provisions of the Medicinal Products Act and of regulations issued on the basis of that Act. In addition, clinical trials of medical equipment are subject to the provisions of the Medical Equipment Act and of regulations issued on the basis of that Act.
Regulation 443/2004, as amended, applies to clinical trials involving humans. It does not apply to medical experiments on individual patients or non-interventional trials.
The Regulation lays down specific provisions concerning the implementation of clinical trials of medicinal products, including multi-centre trials in humans, in particular concerning the implementation of Good Clinical Practice (GCP) in studies on medicinal products.
When processing of personal data in connection with clinical trials, Act No. 77/2000, on Protection of Privacy as regards the Processing of Personal Data, shall apply insofar as specific provisions of the Reg. 443/2004 do not take precedence .
The arrangements, implementation and reporting of all clinical trials of medicinal products, including studies of bioavailability and bioequivalence, must comply with the principles of Good Clinical Practice.
The production and import of medicinal products for clinical trials (investigational medicinal products) shall comply with the provisions of the Regulation on the manufacturing of medicinal products (Reg. Nr 893/2004) and the Regulation on import and wholesale distribution of medicinal products (Nr. 699/1999), as amended.