National regulatory requirements in EU for medicinal products containing GMOs

Publication date 22.2.2018 14.17
Press release

National regulatory requirements in EU for medicinal products containing GMOs

The European Commission has published an overview of national regulatory requirements for investigational medicinal GM products in the EU countries. Currently these countries have varying national interpretations of applying either Directive 2009/41/EC (contained use) or Directive 2001/18/EC (deliberate use) to such research activities.

Working group appointed by the Commission is addressing the coordination of gene technology directives and medicine directives. Information about the results is expected in the autumn 2018.

More information about the Finnish policy is provided by the Board for Gene Technology in the guideline “Production and research use of medicinal products containing GMOs from the perspective of the Gene Technology Act”.

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