HPRA Medicinal Products Newsletter – Issue Number 71 – June 2022

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Published 15 June 2022

Contents in this issue: 


Human Medicines

  • Genotoxic medicinal products and duration of contraceptive use for male and female patients
  • Contamination of (traditional) herbal medicinal products with pyrrolizidine alkaloids
  • Brexit – products availing of a derogation under Directive 2022/642/EC
  • Clinical Trials Regulation


Veterinary Medicines

  • Update on implementation of requirements of Regulation 2019/6

  • Article 34 of Regulation 2019/6

  • New national legislation on veterinary medicines

  • Antiparasitic veterinary medicinal products for food-producing animals

  • Changes in responsibility and personnel changes



  • European Commission call for data on salicylic esters used in cosmetic products

  • Keeping up to date with legal changes to ingredients in cosmetic products

  • Presentations from GDP and GMP conferences

  • Stakeholder consultation – Registration of processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the Clinical Trial Regulation

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