HPRA Medicinal Products Newsletter - Issue Number 56

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In this issue

Human Medicines

  • Preparing for simplified reporting and introduction of the ICH E2B (R3) standard


Veterinary Sciences

  • Brexit and implications for veterinary medicines availability
  • New template for a ‘combined label-leaflet’ now available on the European Medicines Agency’s website
  • EIRCODE and product PIL and labelling
  • Recent updates to Chapters 1 & 3 of EudraLex Volume 6A of the Notice to Applicants
  • Updated versions of the QRD templates (version 8.1) recently published by the European Medicines Agency



  • Concept paper on GMP in relation to marketing authorisation holders
  • US – EU mutual recognition agreement on GMP inspection

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