HPRA Medicinal Products Newsletter - Issue Number 73 - February 2023

Download: hpra-medicinal-products-newsletter---issue-number-73---february-2023.pdf 931 KB

Published 17 February 2023

Contents in this issue:

Human Medicines

  • HPRA identifier for DHPCs and educational materials
  • Clinical trials – deadlines, training, and supports
  • Brexit update
  • Nitrosamines
  • Swift scientific advice (quality sections of dossier)

Veterinary Medicines

  • HPRA welcomes extension to Brexit exemptions for veterinary medicines
  • Change in fee system for veterinary medicines in the EU
  • Changes to the processing of the Summary of Product Characteristics by the HPRA
  • Update on antiparasitic veterinary medicinal products for food-producing animals
  • Recent updates to the pharmacovigilance section of the HPRA website
  • Publication of information on newly authorised centralised veterinary medicines and updating of national product data in the Union Product Database
  • Veterinary medicinal products containing zinc oxide to be administered orally to food-producing species
  • Mock up requirements following G.I.18 variations


  • Requirements for HPRA access to manufacturing sites where batch certification only takes place
  • Adjusting our compliance management approach
  • Registration of processes exempted under Article 61(5) of the Clinical Trials Regulation
  • Common deficiencies issued to wholesale distributors

« Back