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Page 1 of 16
Date Title
21/05/2013 Guide to electronic submissions - human medicines
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
02/05/2013 Application for transfer of a blood establishment authorisation
02/05/2013 Application for transfer of a tissue establishment authorisation
02/05/2013 Application for a GDP certificate
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
18/04/2013 Documents for non-routine import/export of tissues and cells
02/04/2013 Non-technical project summary under Directive 2010/63/EU and S.I. No. 543 of 2012
22/03/2013 Application for a new wholesaler’s authorisation
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
08/03/2013 Controlled drugs licence application form
06/03/2013 Guide to refusals and appeals
05/03/2013 Guide to Parallel Imports - Human Medicines
27/02/2013 Application for a variation to a manufacturing/importation authorisation or wholesaler's authorisation
Page 1 of 16



Date Printed: 22 May 2013

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