HPRA Medicinal Products Newsletter - Issue Number 75 - October 2023

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Published 3 October 2023

Contents in this issue:

Human Medicines

  • Nitrosamine limits
  • Reminder to MAHs to monitor CMDh website for relevant updates
  • Clinical trials – deadlines for transition and guidance

Veterinary Medicines

  • Expansion of the US-EU mutual recognition agreement on GMP inspections
  • HPRA veterinary medicines webinar
  • New classification of supply routes in Ireland
  • New legislation on veterinary medicines
  • Provision of labelling mock-ups


  • Electronic certificates of pharmaceutical product and free sale now available
  • Manufacturer’s /Importer’s Authorisation (MIA) pre-submission process

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