At the moment we do not know when the United Kingdom (UK) will leave the European Union (EU), whether a withdrawal agreement will be reached, and whether there will be a transitional period. That’s why it is important for sponsors and investigators to be prepared for a no-deal Brexit.

In case of a no-deal Brexit on 30 March 2019, the UK will become a so-called ‘third country’, and this may have consequences for the progress of clinical research conducted in the EU. In some cases, an amendment will have to be submitted to the reviewing committee and to the competent authority.

On the CCMO website the consequences are further explained. Please click here for more information.

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