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Date Title
06/11/2009 Checklist for Dossier Requirements
14/03/2013 Clarification on Harmonisation of SPCs and product literature between UK and IE
11/10/2011 Clarification Paper for Joint Labelling between IE and UK
28/09/2010 Clarification Paper: Partnership initiative between the UK, Ireland and Belgium for National application procedures
07/09/2007 CMD(h) Standard Operating Procedure - Procedure For Article 61(3) Changes To Patient Information
25/11/2002 Combining Parenteral Product Containers on one Product Authorisation : Guidance
03/06/2003 Commission Regulations (EC) No 1085/2003 on Centralised Variations
24/04/2013 Display of chemical group symbols on product literature of sheep anthelmintics
28/11/2008 Drug Substance Section of Dossiers - A Regulators view
11/12/2007 Guidance on invented names of medicinal products for human use
01/07/2010 Guide to Batch Specific Requests for Veterinary Medicines
06/11/2008 Guide to Batch-Specific Requests for Human Medicines
21/05/2013 Guide to electronic submissions - human medicines
23/01/2013 Guide to electronic submissions - veterinary medicines
10/04/2012 Guide to Invented Names of Human Medicines
13/02/2013 Guide to Invented Names of Veterinary Medicines
22/05/2012 Guide to labels and leaflets of human medicines
14/08/2012 Guide to Notification of Marketing Status of Human Medicines
15/11/2012 Guide to Notification of Marketing Status of Veterinary Medicines
05/03/2013 Guide to Parallel Imports - Human Medicines
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Date Printed: 25 May 2013

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