HPRA Medicinal Products Newsletter - Issue Number 57

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In this issue:

Human Medicines

  • New EudraVigilance System: Changes to Reporting Requirements - Go-Live Planning
  • Use of the rabbit pyrogen test

Veterinary Sciences

  • Best Practice Guide on Measures Improving Predictability of Submissions/Responses and Adherence to Communicated Submission/Responses Deadlines.
  • Brexit Preparations
  • Outcome of Brexit Survey – Industry Desire to Maintain Joint Labelling
  • Introduction of ‘Value’ or Promotional Packs of Veterinary Medicines
  • Obligations Regarding the Withdrawal of Marketing Authorisations in Ireland
  • Veterinary Medicinal Products containing Zinc Oxide to be Administered Orally to Food - Producing Species.
  • Number 1 in Europe



  • HPRA Regional Information Evenings - Cosmetic Products
  • Responding to a Data Integrity Failure
  • European Commission Delegated Regulation for Safety Features on Medicinal Products for Human Use
  • Updated Quality Defect Reporting Guidance Note and New Reporting Form.

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