Procedures for Clinical Trials in the case of No-Deal-Brexit

Following the signing and ratification by both the British Parliament and the European Parliament of the agreement governing the United Kingdom's withdrawal from the European Union (EU) on 31 January 2020, the European Council adopted the decision to conclude the withdrawal agreement on 30 January 2020. From 01.02.2020, the United Kingdom will therefore be considered a third country. However, a transitional period until 31.12.2020 was agreed in the agreement, during which the conditions and obligations of the acquis communautaire continue to apply to the United Kingdom.

For Austrian law, the Brexit Transitional Act contains provisions for the transitional period: According to these provisions, if federal law refers to the Member States of the EU, this also includes the United Kingdom, provided that none of the exceptions mentioned above apply. Until the end of the transitional period, all regulations that apply to member states of the EEA continue to apply, with a few exceptions.

The exceptions concern the UK's leading role in European procedures and its participation in EU bodies. Both are no longer possible for the United Kingdom from 01.02.2020 - with specific exceptions for participation in committees. The United Kingdom can therefore no longer be an RMS or rapporteur in Voluntary Harmonised Procedure from 01.02.2020. Open procedures are taken up by other RMS or stopped.

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