HPRA Medicinal Products Newsletter – Issue Number 71 – June 2022

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

Compliance

• 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