EMA Tells Pharma Companies to Continue to Prep for UK’s Withdrawal

Regulatory NewsRegulatory News | 25 March 2019 |  By 

With an extension in place that will push the UK's withdrawal from the EU back to either April or May, the European Medicines Agency (EMA) told pharmaceutical companies on Monday to continue their preparations for Brexit.

Under the European Council decision from last Friday, if the withdrawal agreement between the UK and the EU is approved by the UK House of Commons by 29 March 2019, the extension will be until 22 May 2019. But if the withdrawal agreement is not approved by 29 March 2019, the extension will be until 12 April 2019.

“The decision makes clear that the UK remains a Member State for the duration of the extension, with all the rights and obligations set out in the treaties and under EU law,” EMA said.

Based on the European Council decision, EMA also said that the deadline of 29 March 2019 referred to in Brexit-related guidance should be understood to be replaced by 12 April 2019 until further notice.

The European Commission also made the same note about the date being extended in relation to its guidance.

“Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union. In particular, the Commission and the European Medicines Agency expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time, considering the procedural timelines foreseen in the regulatory framework,” EC guidance published in February said.

Meanwhile, in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday updated guidance on written confirmations for export of active substances manufactured in the UK.

Last week, the MHRA published a series of guidance documents relating to marketing authorizations, variations and licensing; importing and exporting; medicines for children; medical devices; and regulatory submissions and vigilance activities.

EMA Brexit-related guidance for companies


© 2023 Regulatory Affairs Professionals Society.

Tags: Brexit, EMA, medicines

Discover more of what matters to you

No taxonomy