Scientific research of medicinal products containing genetically modified organisms (GMO)
Studies with medicinal products containing a GMO as referred to in article 1.1 of the Genetically Modified Organisms (Environmental Management) Decree 2013, are reviewed by CCMO.
In the explanatory notes to the Central Review Decree (BCB), a GMO is defined as:
any organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.
An organism is defined as:
a biological entity capable of replication or of transmitting genetic material.
More information on legislation and regulations for research with GMOs can be found on the website of the Gene Therapy Office.