IMB Newsletter, Issue No. 25 August - December 2006
16 January 2007
Topics for the IMB Newsletter No. 25 include the following:-
Human Medicines
Legislation and Guidelines,
GMP Declarations for Active Substance Manufacturers,
Update on Electronic Reporting of Non-Irish Adverse Reactions,
Information Searches
Veterinary Medicines
Legislation and Guidelines,
Changes in Method of Supply of Intramammary Antibiotics
Requests for Classification
- Update Criteria for Exemption of Certain Veterinary Medicines for Food- Producing Animals from the Requirements for Prescription Control
Guidance on Submission of Type IA and IB Notifications for National Applications Variations Involving DMF’s Access to IMB Data on Authorised Animal Remedies Product Literature in Electronic Format
The alignment of the SPCs for immunological ‘review’ products between the UK and Ireland (IE)
Procedure for joint IMB/VMD assessment of packaging for products authorised through the mutual recognition or decentralised procedures
Compliance
Good manufacturing and market compliance information day November 2006
Controlled drugs information seminar 8 November 2006
Online licence application for controlled drugs
Requirements to Audit API Sites