State Institute for Drug Control

Notice to sponsor/applicant submitting amendment /new data/ change to pharmaceutical documentation for active (ongoing) clinical trials

Information for sponsors - 10.7.2008

Information for sponsors on the import of pharmaceuticals containing narcotic drugs and psychotropic substances - update.  

Information for applicants

Up-to-date information for applicants (e.g. sponsors, contact persons, CRO) submitting applications for approval of a clinical trial on products of the following nature: gene therapy medicinal products, somatic cell therapy medicinal products (including cells of xenogeneic origin) or medicinal products containing genetically modified organisms.  

Clinical trials on products containing genetically modified organisms

Instructions for applicants concerning requirements of the Czech Ministry of the Environment.  

Confirmation of the Approval/Notification of Clinical Trial for the Customs Clearance

The Sample Letter

The Sample Letter of Authorisation for a Legal Person or for a Natural Person (specimen with necessary details).  

Information for sponsors of clinical trials

Information for sponsors of clinical trials on pharmaceutical data submission for new clinical trials with already assessed drug products and the possibility to refer to data submitted in the past.