HPRA Newsletter Issue 49: September - December 2014

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In this Issue


  • Herbal Medicines Information Seminar

Human Medicines

  • Proactive Approach to Reclassification (Switching)
  • New EU Clinical Trials Regulation
  • Reminder to submit Marketing Status Notifications for all authorisations and certificates.​


Veterinary Medicines

  • Certificates of suitability and retest periods
  • Declaration form for the ‘Detailed Description of the Pharmacovigilance System’ relating to applications for veterinary medicinal products.
  • Capacity planning
  • Feedback on Veterinary Medicines Department Information Day


  • New Tools for Manufacturers to help prevent Medicines Shortages
  • Amendment to the Misuse of Drugs Regulations

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