HPRA Medicinal Products Newsletter - Issue Number 74 - June 2023

Published 19 June 2023

Contents in this issue:

Human Medicines

• Mock ups for labels and leaflets

Veterinary Medicines

• Update on implementation of Regulation 2019/6 in relation to Good Laboratory Practice
• Future of joint labelling initiative with the UK
• Labelling requirements in relation to Regulation 2019/6
• Update on national legislation
• Pilot initiative to safeguard availability of veterinary medicines in Ireland
• Updated guidance on presenting adverse event information

Compliance

• Quality defects and recalls
• Requirements for GMP records for receipt of materials
• Advertising human medicines in Ireland