HPRA Medicinal Products Newsletter - Issue Number 75 - October 2023

Published 3 October 2023

Contents in this issue:

Human Medicines

• Nitrosamine limits
• Reminder to MAHs to monitor CMDh website for relevant updates
• Clinical trials – deadlines for transition and guidance

Veterinary Medicines

• Expansion of the US-EU mutual recognition agreement on GMP inspections
• HPRA veterinary medicines webinar
• New classification of supply routes in Ireland
• New legislation on veterinary medicines
• Provision of labelling mock-ups

Compliance

• Electronic certificates of pharmaceutical product and free sale now available
• Manufacturer’s /Importer’s Authorisation (MIA) pre-submission process