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Date	Title
06/03/2013	Guide to refusals and appeals
14/01/2013	Guide to electronic submissions - human medicines
11/05/2012	Guide to submission of Risk Minimisation Plans
10/04/2012	Guide to Invented Names of Human Medicines
10/03/2011	Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product
06/11/2009	Checklist for Dossier Requirements
28/11/2008	Drug Substance Section of Dossiers - A Regulators view
11/02/2008	Guide to the Definition of a Human Medicine
11/12/2007	Guidance on invented names of medicinal products for human use
12/10/2007	Regulation (EC) No 1901/2006 Paediatric Use - Guidance Document
15/06/2007	Notice to Applicant-Module 1 (Part 1A): Volume 2B
14/12/2005	Number of dossiers required : Guidance Document
03/06/2005	Electronic Submission Declaration
09/03/2005	Volume 2B Notice to Applicants- User Guide
25/11/2002	Combining Parenteral Product Containers on one Product Authorisation : Guidance
01/01/2002	Rejection Procedure for Applications