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Date	Title
01/09/2008	Volume 9A of The Rules Governing Medicinal Products in the European Union
09/03/2005	Volume 2B Notice to Applicants- User Guide
14/04/2004	Variations: Submission of Type IA and IB Notifications for National Applications - IMB Guidance
13/05/2010	Update on Herbal Medicinal Products - May 2010
28/12/2011	Traditional Herbal Medicines Registration - Industry Q&A Document
14/04/2011	Traditional Herbal Medicines Registration - Consumer Q&A Document
24/06/2010	Statement of licensing status of pharmaceutical product
18/06/2008	Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues
01/01/2002	Rejection Procedure for Applications
04/01/2013	Regulatory requirements for the procurement, in the Republic of Ireland, of Human Tissues and Cells intended for human application
12/10/2007	Regulation (EC) No 1901/2006 Paediatric Use - Guidance Document
19/07/2012	Registration of persons responsible for placing Medical Devices on the market
19/07/2012	Registration of persons responsible for placing In-vitro Diagnostic Medical Devices on the market
21/12/2012	Registration for brokers of finished medicinal products
14/02/2013	Registration for active substance manufacturers, importers and distributors
08/06/2009	Quality defect investigation reports
19/02/2013	Project authorisations regulated by Directive 2010/63/EU and S.I. No. 543 of 2012
11/10/2011	Product Literature Standard
19/04/2006	Product information requirements under Directive 2001/83EC as amended by Directive 2004/27EC- Further Guidance
14/12/2005	Number of dossiers required : Guidance Document