IMB Newsletter Issue No 29 January - April 2008
03 July 2008
IMB Newsletter Issue No 29
CONTENTS
General
• Staff Changes
Human Medicines
• Periodic Safety Update Reports (PSURs) – Work-Sharing Initiative
• Update on Electronic Reporting Of Adverse Reactions
• Clinical Trial Applications
• Request to all Marketing Authorisation Holders of medicinal products containing active substances in the form of mesilates, (di)isetionates, tosilates or besilates to assess the risk of occurrence of contamination with mesilate esters and related compounds
Veterinary Medicines
• New guidelines adopted by CVMP
• New frequently asked questions on IMB website
• Staff Changes in the Veterinary Medicines Department
• Proposal from the IMB and UK’s Veterinary Medicines Directorate (VMD) Work Sharing between VMD and IMB for National Applications
Compliance
• GMP Updates
• GMP & Market Compliance Information day 2008
• EudraGMP & Manufacturer’s / Importer’s Authorisation (MIA)
• New process for Inspection Reporting
• Inspection Notifications & Electronic Copies of Reports
• Planning of Inspections of Active Substance Manufacturers
• Revised IMB Guidance Note on Parallel Importation
• Risk Assessments and Quality Risk Management Annex 20 (ICHQ9)
• Sampling and Analysis – the IMB’s Request for Sampling & Analysis Supporting Items Form
• Irish Medicines Board, Market Compliance Section, Sampling & Analysis Programme
Statistics