In this issue

Human Medicines

• Preparing for simplified reporting and introduction of the ICH E2B (R3) standard

Veterinary Sciences

• Brexit and implications for veterinary medicines availability
• New template for a ‘combined label-leaflet’ now available on the European Medicines Agency’s website
• EIRCODE and product PIL and labelling
• Recent updates to Chapters 1 & 3 of EudraLex Volume 6A of the Notice to Applicants
• Updated versions of the QRD templates (version 8.1) recently published by the European Medicines Agency

Compliance

• Concept paper on GMP in relation to marketing authorisation holders
• US – EU mutual recognition agreement on GMP inspection