HPRA Medicinal Products Newsletter – Issue Number 77 – June 2024

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Published 21 June 2024

Contents in this issue:

Human Medicines

  • Environmental risk assessment for human medicines
  • Implementation period for product information updates
  • Clinical trials – Important information and updates
  • Applying for a national product or DCP authorisation in Ireland – Slot booking
  • Product information changes
  • Mutual Recognition and repeat use procedure – Proof of payment

Veterinary Medicines

  • G.I.18 VRAs – Guidance on submissions
  • Implementation deadline for G.I.18 VRAs also applicable to products already in the distribution chain
  • Introduction of ‘Umbrella’ type variations
  • Introduction of super grouping and widened scope of technical grouping of VNRAs
  • Update on the joint labelling initiative
  • Provision of labelling mock-ups for joint assessment
  • SPC harmonisation – Action for generic/ hybrid MAHs of Domosedan solution for injection
  • HPRA Information Day on implementation of Regulation 2019/6 in Ireland
  • Publication of veterinary medicines shortages on the HPRA website


  • Importation of exempt medicinal products by the holder of a Wholesale Distribution Authorisation (WDA)
  • GMP records for receipt of materials

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