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Page 1 of 42
Date Title
21/05/2013 Guide to electronic submissions - human medicines
21/05/2013 Drug Safety Newsletter 53rd Edition
21/05/2013 Drug Safety Newsletter 54th Edition
17/05/2013 Avastin (bevacizumab) Important Safety Information from Roche as approved by the Irish Medicines Board
17/05/2013 Synacthen (tetracosactide) Important Safety Information from SOBI AB as approved by the Irish Medicines Board
17/05/2013 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights
15/05/2013 Protelos (strontium ranelate) Important Safety Information from Servier as approved by the Irish Medicines Board
15/05/2013 The European Commission published revision 10 of the application form for a marketing authorisation of a medicinal product for human use in April 2013.
09/05/2013 Guide to Fees and Fee Application Form for Human Products 2013
07/05/2013 Increlex (mecasermin) Important Safety Information from Ipsen as approved by the Irish Medicines Board
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 Fastum Gel (ketoprofen) Important Safety Information from A. Menarini as approved by the Irish Medicines Board
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
02/05/2013 Field Safety Notice Monthly Summary Sheet - April 2013
02/05/2013 Field Safety Notice Summary Sheet - Outstanding Actions
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
Page 1 of 42



Date Printed: 23 May 2013

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