IMB Newsletter Issue No. 27 - 2007
31 August 2007
Irish Medicines Board Newsletter No 27
Topics:
- Human Medicines Information Day – Medicines for Rare Diseases
- IMB Veterinary Information Day 2007
- Staff Changes in the IMB
- Human Medicines New Legislation
- Product Information (SPC, labels & leaflets)
- Marketing Information
- Prescription classification
- Pharmacovigilance
- Electronic Submission of Adverse Reaction Reports
- Article 61(3) Notifications
- Braille Declarations
- Implementation of the Traditional Herbal Medicines Products Directive 2004/ 24/EC and the establishment of the Traditional Herbal Medicinal Products Registration Scheme
- Process Analytical Technology (PAT) Group
- Paediatric Regulations
- Update to the IMB’s Guide to Invented Names of Human Medicines
- Homeopathic medicines
- Veterinary Medicines Legislation and Guidelines
- Changes to listing of authorised veterinary medicinal products on IMB website
- Update on the supply of local anaesthetics for use in livestock
- Updated guideline for the implementation of packaging changes to veterinary medicinal products
- Veterinary Medicines Department
- Compliance Important Information from the Irish Medicines Board in relation to Glycerin contaminated with, or substituted with, Diethylene Glycol
- Wholesale Distributors – establishing bona fides of suppliers and customers
- Medicinal Products (Control of Wholesale Distribution) Regulations 2007
- Manufacture and Wholesaling of Herbal Medicinal Products
- Medicinal Products (Control of Manufacture) Regulations 2007
- Medicinal Products (Control of Advertising) Regulation 2007
- Updates to Annexes of the EU Guide to GMP
- Certificates of Analysis issued by brokers
- Joint Meeting of Interested Parties and GMDP IWG
- Enforcement