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Medicamentos biossimilares na UE

The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a ‘reference’ biological medicine already authorised.

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  • A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
  • Electronic Submission Template for Premarket Approval Applications (PMAs)
  • MDSAP Technical Review and Recognition Decision Procedure
  • Essential Principles and Content of Predetermined Change Control Plans. Final Document
  • Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017 – 2024
  • GMP and GDP Question and Answer Guide Version 03 published by ECA
  • Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 2)
  • Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies

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