HPRA Medicinal Products Newsletter – Issue Number 78 – September 2024

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Published 26 September 2024

Contents in this issue:

Human Medicines

  • Decentralised authorisation applications for 2025
  • Nitrosamines
  • Transfer before authorisation
  • CTR transition period – Deadline approaching
  • Pre-CTA advice pilot
  • Use of medicinal products containing estragole in the flavouring

Veterinary Medicines

  • HPRA Veterinary Medicines Information Day 2024 – Registration now open
  • Important notice for marketing authorisation holders – Submission deadline for G.I. 18 variation applications
  • Website development update
  • Recording suspected adverse events in animals following the use of human medicines

Compliance

  • New Regulation on Substances of Human Origin (SoHO)


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