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Date Title
21/05/2013 Guide to electronic submissions - human medicines
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
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
28/01/2013 Application for a renewal to a registration certificate for a homeopathic medicinal product
14/08/2012 Guide to Notification of Marketing Status of Human Medicines
13/08/2012 Marketing Status Notification Form
10/04/2012 Guide to Invented Names of Human Medicines
17/11/2011 Guide to Transfers of Product Authorisations and Parallel Product Authorisations for Human Medicines
17/11/2011 Transfer of an authorised (parallel) or DPR medicinal product - application form A
21/09/2011 Guide to Renewal of Marketing Authorisations - Human Medicines
25/07/2011 Application for a variation to a parallel import licence
04/04/2011 Transfer of medicinal product before authorisation - application form B
10/03/2011 Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product
21/02/2011 Braille declaration form
09/02/2011 Guide to withdrawal of authorisations or certificates for human medicines
29/11/2010 Application for a Variation to a Registration Certificate for a Homeopathic Medicinal Product
14/10/2010 Guide to Reclassification (Switching) of Legal Supply Status of Human Medicinal Products
09/07/2010 Changes to IMB processes for variation applications for human and veterinary medicines from 1st August 2010 - updated December 2010
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Date Printed: 22 May 2013

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