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Page 1 of 8
Date Title
01/01/2002 Rejection Procedure for Applications
07/05/2002 Guidance Note 10: Guidance Note to Custom Made Dental Device Manufacturers
06/11/2002 Guidance Note 5: Guidance Notes for Manufacturers on Clinical Investigations carried out in Ireland
25/11/2002 Combining Parenteral Product Containers on one Product Authorisation : Guidance
13/01/2003 Incorporation of Safety Data in Product Information at Renewal/Variation : IMB Guidance
03/06/2003 Commission Regulations (EC) No 1085/2003 on Centralised Variations
26/03/2004 Guidance Note 6: Glossary of Terms for Medical Devices
14/04/2004 Variations: Submission of Type IA and IB Notifications for National Applications - IMB Guidance
01/01/2005 IMB Position Paper: Legal Status of Tooth Whitening Products
01/01/2005 List of Narcotic Drugs Under International Control - International Guidance
01/01/2005 List of Psychotropic Substances Under International Control-International Guidance
01/01/2005 List of Precursor Chemicals Frequently Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances Under International Control
01/01/2005 Internationally Published Estimates for Narcotic Drugs
01/01/2005 Internationally Published Assessments for Psychotropic Substances
09/03/2005 Volume 2B Notice to Applicants- User Guide
05/09/2005 Guide: Manufacture of Medical Devices within Healthcare Institutions
14/12/2005 Number of dossiers required : Guidance Document
19/04/2006 Product information requirements under Directive 2001/83EC as amended by Directive 2004/27EC- Further Guidance
01/08/2006 Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC
01/11/2006 Guidlines for Pharmacogenetic research
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Date Printed: 19 May 2013

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