HPRA Medicinal Products Newsletter - Issue Number 54

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Human Medicines

  • EMA - QPPV update – What’s new in Pharmacovigilance – Issue 2 – August 2016
  • Introduction of a Regulatory Contact Point for Marketing Authorisation Holders

Veterinary Medicines

  • Top tips for mock up submissions
  • Dr. David Murphy elected new Chair of EMA Committee for Medicinal Products for Veterinary Use (CVMP)
  • Active Substance supply
  • Future Strategy for the regulation of PBT substances
  • HPRA performance at CMDv


  • Sale or supply of traditional herbal medicinal products (THMPs) that have been granted their certificate of traditional use registration
  • Contamination control Strategy – update from Newsletter 43

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