EMA Closes London Office, Preps for New Time Zone

Regulatory NewsRegulatory News | 01 March 2019 |  By 

After 24 years in London, the European Medicines Agency (EMA) on Friday has officially departed and is on its way to Amsterdam following a Brexit relocation vote in November 2017.

EMA's permanent Amsterdam headquarters, a tailor-made building in the Zuidas business district, are planned for completion next November. On a temporary basis, the Dutch government has granted EMA the Spark building in the Sloterdijk area of Amsterdam until the permanent building is completed. 

The move to Amsterdam also comes with a time zone switch, which could have an impact on submissions and deadlines.

EMA said that during its period of “reduced virtual presence,” from 4 March to 8 March, the agency’s working hours will continue to follow Greenwich Mean Time (GMT).

But from 11 March 2019 onwards, EMA's working hours will then switch from GMT to Central European Time (CET), reflecting EMA's physical relocation. EMA's official business hours will be 8:30-18:00 (CET) and switchboard opening hours will be 7:30-18:30 (CET), Monday-Friday. 

EMA also said it will consider regulatory submissions via the eSubmission Gateway and the Eudravigilance Gateway to have met a deadline of 29 March 2019 if filed on that date by 23:59 and 59 seconds GMT.

“To reduce the risk of complications, EMA will seek to avoid applying a deadline of midnight on 29 March 2019 in areas such as procurement, job vacancies and regulatory submissions. Where this is unavoidable, EMA will individually consider any cases where a third party considers their submission to have been negatively impacted by EMA's change of time zone. EMA will also take account of the impact of its change of time zone wherever a question regarding compliance with deadlines arises,” EMA said.

Change of time zone due to EMA's relocation in March 2019

EMA in London (1995-2019)

To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe.


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Tags: Amsterdam, Brexit, EMA

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