IMB Newsletter Issue No. 36 May - August 2010
17 September 2010
Download: IMB Newsletter Issue No. 36 May - August 2010
General
- Signing of Memorandum of Understanding between The Therapeutic Goods Administration of Australia and the IMB
- Herbal medicines on the Irish market 2010
- Authorisation or registration numbering system
Human Medicines
- Project to update the legal status of centrally authorised medicinal products
- Change in the procedure for requesting Ireland to act as Reference Member State (RMS) in a decentralised procedure for a human medicinal product
Veterinary Medicines
- Collection of data on veterinary consumption of antimicrobials
- Update on status of flukicides without MRL for milk
- Staff changes
Compliance
- Requirements for QP declarations for inclusion of third-country contract manufacturers/testing facilities for IMP authorisation
- Meeting of the PIC/S Expert Circle on active substances
- Persistent Organic Pollutants Regulations 2010, S.I. No. 235 of 2010 ('POPs Regulations')
- Reporting of quality defects
- Micronisation of active substances
- Controlled drugs - update to Misuse of Drugs Regulations 2010
- Use of small volume cold chain insulated shippers
- Cosmetics update
- Joint inspections with the US FDA (notice reprinted from EMA website)
- GMP and market compliance information day