IMB Newsletter Issue No.24 April - September 2006
01 September 2006
IMB Newsletter No.24 April-September 2006
General Controlled Drugs Seminar 8th November 2006,
GMP and Market Compliance, Information Day 9th November 2006,
Staff Changes
Human Medicines
Legislation and Guidelines,
Guide to clinical trial applications and frequently asked questions,
Provision of usage data, Use of invented names for modified release or prolonged release generics,
Invented Product Names – 2005 Review,
Use of trading styles, Information on Human Medicines,
Notice to Applicants,
Guideline on Dossier Requirements for Type 1A and Type 1B Notifications – June 2006 Revision
Veterinary Medicines
Legislation and Guidelines,
Changes in routes of supply for intramammary antibiotics,
Written communication with applicants,
Harmonised product literature,
IMB labeling requirements,
Publication of public assessment report,
Register your own subscriptions to the IMB newsletter,
Update on changes to the mutual recognition procedure and decentralised procedure,
Use of veterinary medicinal products intended for use as top dressing of foods,
IMB veterinary information day
Compliance
Questionaire on active substance,
Revised format for manufacturer’s licence Statistics