Medicinal products

Genetically Modified Organism (GMO) aspects for investigational medicinal products

The country fiches below provide an overview of national regulatory requirements (EU countries and Norway) for medicinal products containing GMOs.

In the country sheets, the term "contained use" is used to refer to Directive 2009/41/EC (as implemented in the relevant country), while the term "deliberate release" is used to refer to Directive 2001/18/EC (as implemented in the relevant country).

Please note that the European Commission is not responsible for the accuracy of information displayed in the country sheets. Developers of medicinal products that contain or consist of GMOs, are reminded that the information contained in the country sheets has no legal value and that the relevant competent authorities should be contacted for additional information below.

Overview of national requirements:

Austria Italy
Belgium Latvia
Bulgaria Lithuania
Croatia Luxembourg
Cyprus Malta
Czechia Netherlands
Denmark Poland
Estonia Portugal
Finland Romania
France Slovakia
Germany Slovenia
Greece Spain
Hungary Sweden
Ireland United Kingdom

EEA Countries

Norway