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Gene Therapy Legislation in Europe

The implementation of the European Union (EU) directives and guidelines for clinical gene therapy trials in the different EU member states and other European countries is gathered for the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

The EU also provides an overview of national regulatory requirements (EU countries and Norway) for medicinal products containing GMOs. This overview has been developed in 2018 as a result of joint efforts to harmonize between the GMO legislation and the legislation on medicinal products.