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Gene Therapy Legislation in Czech Republic

The competent authorities are the State Institute for Drug Control and the Ministry of the Environment of the Czech Republic. According to the Czech legislation on medicinal products, applicants for authorisation to conduct a clinical trial involving products containing genetically modified organisms (GMOs) are required to obtain an authorisation for the use of GMOs as specified by the Act No. 78/2004, on the Use of Genetically Modified Organisms and Genetic Products. Such authorisation, issued by the Ministry of the Environment, should either be attached to the documentation on making application to the State Institute for Drug Control (SUKL) for a clinical trial authorisation, or submitted subsequently, however, no later than three days prior to the final outcome of the assessment process.

The Czech Act No. 78/2004 on the Use of Genetically Modified Organisms and Genetic Products, as amended, covers the contained use, deliberate release of GMOs into the environment and placing on the market of GMOs as such or in products, including the export and import thereof. Formats of notifications for the use of GMOs, procedure of risk assessment and other requirements are laid down in the implementing Decree No. 209/2004, on Detailed Conditions for the Use of Genetically Modified Organisms and Genetic Products.

More information can be found at the Czech Biosafety Clearing House site (BCH). At the BCH page on legislative and guidelines there is a special text on clinical trials as well.

(Last reviewed by the Competent Authority: 26 April 2010)