Regulatory guidance for pharmaceutical companies to prepare for UK's withdrawal from EU

EMA and European Commission publish updated Q&As

The European Medicines Agency (EMA) and the European Commission have published additional guidance.

Companies are reminded to plan in advance for the situation that the United Kingdom (UK) will leave the EU on 29 March 2019 in order to avoid any impact on the continuous supply of medicines for human and veterinary use within the EU.

This version is an update of the initial questions-and-answers document that was published at the end of May 2017. Updates are marked 'NEW' and include additional information on how the UK's withdrawal from the EU will affect marketing applications and authorisations for different types of medicinal products, for example, generic, hybrid and biosimilar medicines.

The guidance relates to both human and veterinary medicines, unless otherwise indicated.

Earlier this week, the Agency published the first version of its procedural guidance for industry which outlines the practical and simplified requirements that companies should follow to make sure that necessary changes to their marketing authorisation are made by the end of March 2019, to allow for the continued marketing of their medicine in the European Economic Area (EEA) after Brexit.

Companies are advised to regularly check EMA's dedicated webpage on the consequences of the UK's withdrawal from the EU.

This questions-and-answers document follows the publication of the notice to stakeholders of centrally authorised medicines for human and veterinary use  on 2 May 2017.