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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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  • EMVO Systems Updates | May 2026
  • EU agrees to simplify AI rules to boost innovation and ban ‘nudification’ apps to protect citizens
  • Formação DIGITAL PROMO REVIEW : ” Formação muito interativa , bem estruturada e com elevada partilha de casos práticos “
  • Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation
  • COMMISSION IMPLEMENTING REGULATION laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated
  • MASTER COURSE SUPLEMENTOS ALIMENTARES : “Evento muito bem organizado, conduzido e menistrado “
  • Guidelines on the best practices for the traceability of medicines in hospital settings
  • MDCG 2021-12 Rev.2 FAQ on the European Medical Device Nomenclature (EMDN) Revision 2 – April 2026

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