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Page 1 of 8
Date Title
09/05/2013 Guide to Fees and Fee Application Form for Human Products 2013
04/05/2013 Guide to practices exempt from the scope of Directive 2010/63/EU and S.I. No. 543 of 2012
03/05/2013 Individual applications regulated by Directive 2010/63/EU and S.I. No. 543 of 2012
01/05/2013 Compliance with Directive 2010/63/EU and S.I. No. 543 of 2012
26/04/2013 Guide to applying for a variation to a blood establishment authorisation
26/04/2013 Guide to applying for a variation to a tissue establishment authorisation
24/04/2013 Display of chemical group symbols on product literature of sheep anthelmintics
02/04/2013 Non-technical project summary under Directive 2010/63/EU and S.I. No. 543 of 2012
14/03/2013 Clarification on Harmonisation of SPCs and product literature between UK and IE
13/03/2013 Guide to Electronic Transmission of ICSRs and SUSARs associated with the use of Human Medicines
06/03/2013 Guide to refusals and appeals
05/03/2013 Guide to Parallel Imports - Human Medicines
28/02/2013 Guide to hospital-based advanced therapy medicinal products
27/02/2013 Application for a variation to a manufacturing/importation authorisation or wholesaler's authorisation
19/02/2013 Project authorisations regulated by Directive 2010/63/EU and S.I. No. 543 of 2012
14/02/2013 Registration for active substance manufacturers, importers and distributors
13/02/2013 Establishment authorisations regulated by Directive 2010/63/EU and S.I. No. 543 of 2012
13/02/2013 Guide to Invented Names of Veterinary Medicines
07/02/2013 Frequently asked questions on applications under Directive 2010/63/EU and S.I. No. 543 of 2012
23/01/2013 Guide to electronic submissions - veterinary medicines
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Date Printed: 19 May 2013

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