IMB Newsletter Issue No. 33 May - August 2009
22 October 2009
General
- Pandemic Flu Business Continuity Planning
Human Medicines
- Variations Regulation (EC) No. 1234/2008
- Public consultation process on the 'Guide to Electronic Submissions of Applications for Authorisations and Registrations of Human Medicines'
- Informed consent documents for clinical trials - Priority assessment
- Guidance for label/leaflet combinations
- IMB update on MEDDRA and the MSSO
- Update on status of electronic submisson of adverse reaction reports by marketing authorisation holders and clinical trial sponsors
Veterinary Medicines
- Variations Regulation (EC) No. 1234/2008
- Pharmacovigilance inspections
- Replacement of target animals used in batch safety testing of veterinary vaccines
- Working group on classification of method of supply of veterinary anti-parasitic agents for companion animals
- IMB Veterinary regulatory fee consultations
- Organogram of Veterinary Medicines Department
- Staff changes
- Resignation from the Advisory Committee for Veterinary Medicines
Compliance
- EUDRAGMP
- Issue of free sale certificates for medical devices by IMB Compliance Department
Statistics