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Brexit and EU rules for medicinal products for human use and veterinary medicinal products

  • 7 March 2019
  • API, batch release, Brexit, CP, EC, EMA, finished product, GMP, impact, import, legal consequences, MA, MAH, manufacture, marketing authorisation, marketing authorisation holder, medicinal products, notice, QPPV, ratification, RMS, site, transfer, transition period, UK's withdrawal, variation, Withdrawal Agreement,
DO NOT RELY ON THE TRANSITION PERIOD!   The European Commission have published revised versions of Notice to stakeholders and Questions and Answers (Q&As) documents in 22 official EU languages. DO NOT RELY ON THE TRANSITION PERIOD!   DOCUMENTS:       DO NOT RELY ON THE TRANSITION PERIOD!     Sources: EC, EMA  
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Brexit and EU rules in the field of clinical trials (CTs)

  • 5 March 2019
  • Brexit, clinical trials, CT, database, EC, EudraCT, IMP, import, investigational medicinal product, legal consequences, notice, sponsor, UK's withdrawal,
In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, sponsors (both academic researchers and pharmaceutical companies) conducting or planning to conduct clinical trials, as well as investigators and other persons involved in the preparation and conduct of clinical trials in the EU are reminded of legal repercussions, which
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