HPRA Medicinal Products Newsletter – Issue Number 76 – February 2024

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Published 19 February 2024

Contents in this issue:

Human Medicines

  • Clinical trials – Important dates and information
  • Swift written scientific advice – Quality and regulatory queries
  • Brexit and the Windsor Framework deadline of 31 December 2024
  • Multilingual packaging pilot

Veterinary Medicines

  • Alignment of product information with version 9.0 of the QRD templates
  • HPRA Information Day on the implementation of Regulation 2019/6 in Ireland
  • Implementation of Article 107 of Regulation 2019/6
  • implementation of fee increases for veterinary medicines
  • National legislation on veterinary medicines
  • Review of impact of Regulation 2019/6 on the HPRA’s Veterinary Sciences Department
  • Updating the adverse events section of the product information
  • Deadlines for the submission of sales data on veterinary medicinal products to the Union Products Database


  • Chemicals now scheduled as Category 1 Precursor Chemicals

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