IMB Newsletter Issue No.26 April - July 2007
13 July 2007
IMB Newsletter No. 26 - January-April 2007
General
Upcoming Events, Staff Changes, New Staff Appointments in the Veterinary Medicines Department.
Human Medicines
Legislation and Guidelines,
Update on Draft Medicines Regulations,
Update on Implementation of Traditional Herbal Medicinal Products Directive (2004/24/EC),
Homeopathic Medicines: Legislative Issue Update,
Reconstitution of Finished Products Prior to Analytical Testing,
Listing of Manufacturing Sites on Product Authorisations
Veterinary Medicines
Legislation and Guidelines,
Change to the National Legislation Underpinning IMB Authorisation of Veterinary Medicines,
Classification of Routes of Supply of Veterinary Vaccines,
Procedure for Co-ordinating the Joint Assessment of Product Literature by the UK and Ireland for Products Authorised through Mutual Recognition and Decentralised Procedures
Compliance
QP discretion / Compliance with the Marketing Authorisation,
GMP for certain excipients,
Japanese MRA / Record Retention for Biologicals,
Achieving Compliance with the Braille and other requirements for labels and package information leaflets (Ref: Article 56a of Directive No. 2001/83/EC),
IMB Market Compliance Activities,
Braille Dot height Issues,
Pharmaceutical Form Issues
Statistics