RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    EMA to Cease Printing and Dispatching of CPPs During Relocation to Permanent Building

    As the European Medicines Agency (EMA) relocates within Amsterdam, the agency said on Tuesday that it will temporarily cease its printing and dispatching of Certificates of Pharmaceutical Products (CPPs) from 13 December until 18 January 2020. CPPs confirm the marketing authorization status of products authorized through the centralized procedure and they confirm compliance with good manufacturing practices. The temporary halt is occurring because of the agency’s rel...
  • Regulatory NewsRegulatory News

    EMA Launches Operations in Amsterdam

    The European Medicines Agency (EMA) on Monday kicked off operations at its temporary premises at the Spark building in Amsterdam Sloterdijk after moving out of its Canary Wharf office in London on 1 March.   EMA says it is also working with Dutch authorities to finish readying its temporary premises ahead of 30 March, when the agency’s seat officially switches from London to Amsterdam.   “By Monday 18 March, when EMA will be settled in the Spark building, close to ...
  • Regulatory NewsRegulatory News

    EMA Closes London Office, Preps for New Time Zone

    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....
  • Regulatory NewsRegulatory News

    EMA Updates on Priorities Ahead of Netherlands Move

    Two months out from when the UK will officially exit the EU, the European Medicines Agency (EMA) on Wednesday provided an update on its move to the Netherlands and clarified its priorities in the new year.   With the anticipated loss of 25% of its staff , EMA says it must continue to prioritize its activities according to its business continuity plan (BCP) through at least the first half of 2019.   "The focus will be on the authorization, maintenance and supervi...
  • Regulatory NewsRegulatory News

    EMA: Amsterdam HQ Won't Be Ready in Time for Move

    The European Medicines Agency (EMA) on Friday said that its new headquarters in Amsterdam will not be complete until November 2019, eight months after the agency must move from its current offices in London. EMA's Management Board was briefed on the agency's relocation plans at its meeting earlier this week, and said it was pleased with accommodations offered by the Dutch government. The announcement comes less than a month after the European Council chose Amsterdam t...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA’s Rent Bill at €448M (30 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. New Calculation Puts EMA’s Ongoing London Rent Bill at €448M The European Medicines Agency (EMA) faces a €448 million ($531 million) bill for the remaining years on its London rental contract. That new calculation of the cost of EMA’s failure to put a break clause into the contract is notably more than the €348 million estimate suggested by the European Parliament earl...