Download: IMB Newsletter Issue No. 32
General
· Staff changes
· New IMB Structure
Human Medicines
· Dear Healthcare Professional Communications
· Update on regulatory requirements for electronic submission of adverse reaction reports
· Assessment of variations that affect product information by medical or pharmaceutical assessors
· Deadline for Braille Requirements
· Use of invented names for modified release or prolonged release products
· Procedure for changes to labels and/or package leaflet following MR Type I Notifications
· Implementation of the provisions for labels and package leaflets (Title V of Directive 2001/83/EC as amended) for products either on the market or for which an application had been received prior to 23rd July 2007
Veterinary Medicines
· IMB Vet Info Day on Tuesday 8th September 2009
· Joint labelling for use in Ireland and UK
· Key performance highlights of 2008 and plans for 2009
· New cover letter template available for Mutual Recognition or Decentralised Procedures.
· Staff changes in the Veterinary Medicines Department
Compliance
· Expired or Withdrawn Wholesale Authorisations
· Package Leaflets and Patient Information on the Packaging of Medicinal Products
· Non-compliance with GMP for CEP holders (active substance manufacturers)
· New System for Controlled Drug Licences
· Issue of Free Sale Certificates for Medical Devices by IMB Compliance Department
· GMP inspections at Irish manufacturing sites by other regulatory authorities
· Wholesale – establishing entitlement to receive medicinal products
· Update to IMB Wholesale Guidance document
Statistics