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Page 1 of 5
Date Title
04/03/2010 Variation application form for Herbal Medicinal Products
04/04/2011 Transfer of medicinal product before authorisation - application form B
17/11/2011 Transfer of an authorised (parallel) or DPR medicinal product - application form A
30/09/2007 Transfer Application Forms for Veterinary Medicines
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
24/06/2010 Statement of licensing status of pharmaceutical product
20/12/2012 Serious adverse event (SAE) / Serious adverse reaction (SAR) report form - Organs
15/05/2012 Request for Ireland to act as RMS in an MRP for medicinal products for human use
18/05/2009 Request for Classification of a Medical Device
02/10/2007 Request for classification of a human medicine : Application Form
02/10/2009 Request for classification of a borderline product for animal use
08/01/2013 Regulatory Affairs Contact Information
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
01/11/2006 Protocol Template for Investigator-Led Trials
19/02/2013 Project authorisations regulated by Directive 2010/63/EU and S.I. No. 543 of 2012
03/04/2009 Price Certificate
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Date Printed: 22 May 2013

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