HPRA Medicinal Products Newsletter - Issue Number 54

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

Compliance

• 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