HPRA Medicinal Products Newsletter - Issue Number 66

Download: hpra-medicinal-products-newsletter-issue-66.pdf 1 MB

Published 21 September 2020

In this issue

Human Medicines

  • COVID-19: Queries and Updates
  • COVID-19 Update
  • Getting Brexit Ready
  • Nitrosamine Impurities: Conclusion of Nitrosamines 5.3 Review and Requirements for Chemical and Biological Products
  • Interchangeable Medicinal Products
  • IE Requirements Regarding Release of Batches of Vaccines or Blood-derived Medicinal Products
  • Multilingual Packaging Update


Veterinary Medicines

  • Brexit Implications for Veterinary Medicinal Products on the Market in Ireland
  • Changes to Submission Requirements of Joint-labelled Mock-ups Post Renewal Procedures
  • Ongoing Operations during the COVID-19 Pandemic
  • HPRA Input into Revision of National Legislation on Veterinary Medicinal Products



  • Controlled Drugs: Notice Regarding PharmaTrust
  • Inclusion of Postcodes (Eircodes) on MIAs and GMP Certificates
  • European Commission Call for Data on Prostaglandins and their Analogues used in Cosmetic Products
  • Brexit Transitional Period: Implications for Cosmetic Product Companies up to 31 December 2020
  • Addition of Imported Medicinal Products to Annex 8 of a Manufacturer’s / Importer’s Authorisation (MIA)
  • Distant Assessments (Remote Inspections)


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