Hyperion Pharma Consultancy

Nederland

Vlasmeerstraat 90
5261 TC Vught

T: +31 (0) 641221798 
E: info@hyperion-consultancy.nl
W: www.hyperion-consultancy.nl

Geschreven door Wolter de Vries
Applications to host EMA Headquarters

Applications to host EMA Headquarters

The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The agency will need to be relocated in the context of the UK's withdrawal from the EU. There have been 19 offers to host the European Medicines Agency (EMA).

The cities that have applied to host the EMA as of 1 August 2017 are:

  • Amsterdam, The Netherlands
  • Athens, Greece
  • Barcelona, Spain
  • Bonn, Germany
  • Bratislava, Slovakia
  • Brussels, Belgium
  • Bucharest, Romania
  • Copenhagen, Denmark
  • Dublin, Ireland
  • Helsinki, Finland
  • Lille, France
  • Malta
  • Milan, Italy
  • Porto, Portugal
  • Sofia, Bulgaria
  • Stockholm, Sweden
  • Vienna, Austria
  • Warsaw, Poland
  • Zagreb, Croatia

The Commission's assessment will be published online 30 September 2017, then the European Council will have a political discussion based on the assessment at the General Affairs Council (Article 50 format) in October 2017. The vote will consist of successive rounds as needed, with the votes cast by secret ballot and each of the 27 member states having the same number of votes.

A final decision will be taken at the General Affairs Council and announced 20 November 2017.

The assessment will be based on six criteria including:

  • operationality guarantees (the availability of appropriate offices),
  • location accessibility (which includes the frequency and duration of flight connections),
  • schools for EMA staffers' children (including the availability of multi-lingual schools),
  • access to the labor market and health care for staffers' families, business continuity (to maintain and attract highly qualified staff) and
  • geographical spread.

In addition to the release of the applications, EMA said Tuesday that it will temporarily suspend several activities as part of its business continuity plan:

  • the development of the European Medicines Web Portal, a new publicly-available online information source on all medicines marketed in the EU;
  • EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorisation requests for human and veterinary medicines in a secure and efficient way;
  • the development of a transparency roadmap for EMA that lays out future transparency measures of the Agency; and
  • participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.
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