IMB Newsletter Issue No. 31 September - December 2008
03 February 2009
Download: IMB Newsletter Issue No. 31
General
• Staff changes
Human Medicines
• Fee Changes for 2009
• Update on regulatory requirements for electronic submission of adverse reaction reports
• Provision of Data on the Detailed description of the Pharmacovigilance System (DDPS)
• Clarification regarding medicinal status of certain products containing vitamins under the Medicinal Products (Prescription and Control of Supply) Regulations 2003 – 2008.
• Braille and patient-accessible leaflets – Requirement to comply by 30 October 2010
• Requirement for submission of Article 61(3) notifications following a change in the name of a medicinal product.
• National Authorisation Renewal Applications
Veterinary Medicines
• Fee Changes for 2009
• Ideas for Improvement in Communications
• IMB Veterinary Pharmacovigilance Information Day 2008 Newsletter
• Resignation from Membership of Advisory Committee for Veterinary Medicines
• Staff Changes in the Veterinary Medicines Department
• Suspected Adverse Reaction Reporting Requirements
• Veterinary Medicines Information Day
Compliance
• Export Certification Scheme Update
• Materials Management & Ensuring the Supply Chain
• Reduced Testing of Raw Materials
• EU GMP Guide Annexes - Supplementary Requirements - Annex 19 Reference and Retention Samples
• EMEA publishes a concept paper on the revision of the Guideline on Parametric Release.
• QP declarations in relation to ‘Atypical’ Active Substances
• European Legal Proposal Amending Directive 2001/83/EC to Combat Counterfeit Medicinal Products in the EU
• Revision of Annex 1
• Good Manufacturing Practice (GMP) and Market Compliance Information Day
Statistics