Irish Medicines Board Newsletter No 28 September - December 2007
19 February 2008
Irish Medicines Board Newsletter No 28 - September - December 2007
General
Staff Changes, IMB’s new website, Annual Meeting of National, Pharmacopoeia Secretaries, Heads of Medicines Agencies, Working Group of Enforcement Officers.
Human Medicines
Article 61(3) Notifications for products authorised via the Mutual Recognition and Decentralised Procedures, Variations to change the name and/or address of the Product Authorisation (PA) holder, Reminder to submit Marketing Status Notifications for all authorisations and certificates, Update on Electronic Reporting of Adverse Reactions Occurring Outside the European Economic Area, Agreement of product names in the national phase of MR/DC procedures.
Veterinary Medicines
Receipt of notice that application has been validated, Submission of applications to IMB, IMB Veterinary Medicines Information Day 2007, IMB packaging harmonisation initiatives, IMB initiative on unique, low-volume, needed veterinary medicines, IMB policy in relation to the classification of methods of supply for veterinary vaccines, Personnel changes in the Veterinary Medicines Department, Fee changes for 2008, Approved EU Guidelines, Provision of exemptions from the requirement for a marketing authorisation for certain categories of veterinary medicines.
Compliance
Notification System for Exempt Medicinal Products 6
Statistics