IPEC e-newsletter - Excipients Insight October 2018 - 31-10-18

 

Inside this issue

     

EMA updates on Brexit contingency plans

The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, as announced earlier this year.

The agency says the temporary suspension or reduction of additional activities will allow it to safeguard core activities related to the evaluation and supervision of medicines while preparing for the consequences of the UK's exit from the EU - both in terms of the impact on the agency’s operations, as well as its physical move to Amsterdam. It will also help it cope with anticipated staff losses.

“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. More information here.

 

 

 

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