Brexit preparation for EMA and pharmaceutical companies

On 20 November 2017, the EU Council announced that Amsterdam will be the new location for the European Medicines Agency (EMA) after the UK will withdraw from the European Union. Preparing for the consequences of the Brexit, such as the relocation, is not only a significant matter for the EMA itself, but equally important for companies and other private parties.

Therefore, on 28 November 2017, the EMA published a guidance paper to help pharmaceutical companies prepare for the UK´s withdrawal from the EU. The guidance takes as a starting point that the UK will become a third country as of 30 March 2019. According to the regulatory requirements with regard to the marketing of both human and veterinary medicines applicable in the EU and the EEA, the marketing authorisation holder for medicinal products (MAH) must be established in the EU or the EEA. For centrally authorised medicinal products the MAH established in the UK will therefore need to transfer its marketing authorisation to a holder established in the EEA in order to continue to market its products in the EEA after Brexit.

Furthermore, for the marketing of a medicine in the EU/EEA it is required that some activities, such as the activities relating to pharmacovigilance or batch release, are performed in the EU (or EEA). For the continued marketing of medicines in the EEA after this so called “cut-off” date of 30 March 2019 companies should already start preparing for the application for changes to their marketing authorisation. The EMA guidance document outlines the practical and simplified requirements that companies should follow.

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Compliments of Houthoff, a member of the EACCNY