HPRA Newsletter - Issue 52 - January 2016

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In this Issue


  • New Chief Executive Appointment


Human Medicines

  • Emergency Medicines - The Medicinal Products (Prescription and Control of Supply)
    (Amendment) (No.2) Regulations 2015, SI No 449 of 2015#
  • Introduction of Educational Materials for medicines on HPRA.ie


Veterinary Sciences

  • Change to mock up submission to the HPRA
  • Clarification of changes to mock ups
  • Personnel changes in Veterinary department
  • Fee update
  • Update on legislative proposal for new EU Regulation
  • Update to the product literature standard
  • Use of animal test methods for regulatory testing of human



  • Change to requirements regarding Applications for Certificates of
    Pharmaceutical Product and Certificates of Free Sale for medicines
    authorised by the HPRA.
  • Importation of Controlled Drugs
  • Exporting Controlled Drugs
  • European Commission Delegated Regulation for Safety Features on
    Medicinal Products for Human Use
  • Sale or supply of traditional herbal medicinal products (THMPs) that are
    the subject of transitional protection
  • Revision to Annex 16 of the EU GMP Guide: Certification by a Qualified
    Person and Batch Release
  • Quality Defect Investigations – Guidance in relation to Reporting
    and Information Gathering


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