HPRA Medicinal Products Newsletter - Issue Number 58

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In This Issue:

Human Medicines

  • Follow-up of adverse reaction reports
  • Audits of type IA notifications:2016/2017 review


Veterinary Sciences

  • HPRA veterinary science information day 2018
  • Brexit update
  • Joint-labelling of veterinary medicines
  • Response to HPRA survey on Irish language information
  • Updating the SPC as a result of a variation
  • Staff changes in the veterinary medicines team



  • Cosmetic products notification portal
  • Understanding and using CosIng – the Cosmetic Ingredient Database
  • Temperature mapping in storage areas for medicinal products
  • Submission of annual returns – controlled drugs
  • Submission of Annual Returns – precursor chemicals
  • Precursor chemical regulatory update
  • Misuse of Drugs legislative amendments
  • Safety features and the impact on wholesale distribution authorisation (WDA) holders
  • GMP Guidance for consultation
  • Update on regulatory oversight of outsourced storage of stability samples
  • New regulatory approach for contract laboratories
  • Brexit: Transfer of responsibility for EU batch certification and wholesaling activities

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