In this Issue
Human Medicines
• Brexit MAH survey and medicine supply
• Reminder to MAHs to monitor CMDh website for relevant updates’
• Urgent name change request for liposomal* products
• Sites of batch release and product leaflets
• Updating Marketing Authorisations (MAs) for non-marketed products
• Outgoing supplement fee for variations
Veterinary Medicines
• Progress update on the task force report on the method of supply of antiparasitic veterinary medicinal products that are intended for food-producing animals
• Type 1A variations: Opportunities for Improvement
• Update to process for submitting New National Applications
• Update on Irish Language Case
• Update to process where SPCs are updated during a variation
Compliance
• Updates to the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 - 2019
• Update on US - EU mutual recognition agreement on GMP inspection
• Extension of Safety Features ‘Use and Learn’ Period in Ireland beyond September 2019
• Brexit preparedness - Have you verified if your cosmetic product has a Responsible Person registered within the ‘EU-27’ Member States?
• Staff changes in the Compliance GMP Team
Brexit preparedness checklist