EMA Regulatory Guidance for industry to prepare for the UK’s withdrawal from the EU

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

1st June 2017

The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including:

  • The location of orphan designation holders,
  • Qualified persons for pharmacovigilance (QPPVs) and
  • Companies manufacturing and batch release sites.

In this regard, marketing authorisation holders of centrally authorised medicinal products for human and veterinary use are reminded of certain legal consequences that need to be considered in a timely manner.

For more information please refer to the Q&A document here


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