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About the changes of Government Decree 235 of 2009 (X.20.)

In September 2017 Government Decree 250 of 2017. (IX.5.) entered into force, modifying certain healthcare, health insurance and pharmaceutics related government decrees.
On 7 September 2017 Government Decree 250 of 2017. (IX.5.) regarding the modification of certain healthcare, health insurance and pharmaceutics related government decrees entered into force, hereby modifying the Government Decree 235 of 2009. (X.20.) („Government Decree”) regarding the rules of the authorization procedure of medical research, clinical trials of products intended for human use, as well as the clinical trials of medical devices for human use, intended for clinical trials.

The changes of the Government Decree entering into force on 1 January 2018 concern the modification of the research and examination project. In the Hungarian text a slight difference can be found in the wording between the previous version and the one entering into force.

As a new provision entering into force on 1 February 2018 the Government Decree regulates the authorization of research involving ionizing radiation, the serves compliance with EU legal acts (Euratom).