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Page 1 of 3
Date Title
21/05/2013 Guide to electronic submissions - human medicines
06/03/2013 Guide to refusals and appeals
05/03/2013 Guide to Parallel Imports - Human Medicines
14/08/2012 Guide to Notification of Marketing Status of Human Medicines
13/08/2012 Marketing Status Notification Form
22/05/2012 Guide to labels and leaflets of human medicines
11/05/2012 Guide to submission of Risk Minimisation Plans
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
04/03/2010 Variation application form for Herbal Medicinal Products
18/02/2010 Notification of Withdrawal of Authorisations or Certificates for Human Medicines: Application Form
08/01/2010 Application for variation to a marketing authorisation
18/12/2009 New Variations Regulation - key points to note
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Date Printed: 19 June 2013

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