The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, as announced at the beginning of August 2018.
The temporary suspension or reduction of additional activities in this phase allows the Agency to safeguard core activities related to the evaluation and supervision of medicines while the Agency prepares for the consequences of the United Kingdom’s (UK) exit from the European Union (EU) – both in terms of the impact on the Agency’s operations, as well as its physical move to Amsterdam. It will also help the Agency cope with anticipated staff loss.
“EMA will now temporarily suspend or scale back additional activities to ensure that resources can be redeployed so that its core activities can continue without interruption and to the same quality,” commented Noël Wathion, EMA’s Deputy Executive Director. “Over the next few months, EMA will continue to carefully monitor staff intentions to relocate and the anticipated impact on its activities whilst planning for the critical time period when the Agency will be moving to its new premises in Amsterdam.”
The measures announced on 1 August included, among others, the scaling back of guideline development and revision and the putting on hold of non-product related working parties from 1 November 2018. The Agency has now drawn up priority lists of those guidelines and working parties, which will exceptionally continue during BCP phase 3.
Detailed information is available in the PDF iconBCP phase 3 implementation plan.