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Date Title
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
18/06/2008 Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues
20/08/2008 Adverse Reaction/Event Report Form Human Tissues and Cells
20/02/2009 Advanced Therapy Medicinal Products Regulation - Frequently Asked Questions
04/09/2009 Application to make a variation to a tissue establishment authorisation
02/10/2009 Application to make a variation to a blood establishment authorisation
07/04/2011 Notification for invalidation fee
23/05/2011 Application form for blood establishment authorisation
23/05/2011 Application for a tissue establishment authorisation
23/07/2012 Tissue establishment annual report for year ending 31st Dec 2011
23/07/2012 Tissue establishment annual report for reproductive tissues and cells for year ending 31st Dec 2011
23/07/2012 Guide to completion of the tissue establishment annual report for reproductive tissues and cells
23/07/2012 Guide to completion of the tissue establishment annual report
20/12/2012 Serious adverse event (SAE) / Serious adverse reaction (SAR) report form - Organs
20/12/2012 Guide to the completion of the Hospital Blood Bank Annual Report
20/12/2012 Hospital Blood Bank Annual Report
20/12/2012 Hospital Blood Bank Annual Report Appendix 1
04/01/2013 Regulatory requirements for the procurement, in the Republic of Ireland, of Human Tissues and Cells intended for human application
18/04/2013 Documents for non-routine import/export of tissues and cells
26/04/2013 Guide to applying for a variation to a blood establishment authorisation
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Date Printed: 19 May 2013

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