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Date Title
17/10/2011 Notification of Withdrawal of Authorisations or Certificates for Veterinary Medicines
17/10/2011 Guide to Transfer of Veterinary Product Authorisations
17/10/2011 Guide to the Decentralised and Mutual Recognition Procedures for Veterinary Medicinal Products using Ireland as RMS
11/10/2011 Clarification Paper for Joint Labelling between IE and UK
11/10/2011 Product Literature Standard
21/09/2011 Guide to Renewal of Marketing Authorisations - Human Medicines
10/03/2011 Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product
17/02/2011 New Variations Regulations - Key Points to Note
17/02/2011 Important links to documents related to new Variations Regulation
09/02/2011 Guide to withdrawal of authorisations or certificates for human medicines
28/09/2010 Clarification Paper: Partnership initiative between the UK, Ireland and Belgium for National application procedures
01/07/2010 Guide to Batch Specific Requests for Veterinary Medicines
13/05/2010 Update on Herbal Medicinal Products - May 2010
11/05/2010 Guide to the National Rules Scheme for Homeopathic Medicinal Products for Human use
18/12/2009 New Variations Regulation - key points to note
06/11/2009 Checklist for Dossier Requirements
28/11/2008 Drug Substance Section of Dossiers - A Regulators view
06/11/2008 Guide to Batch-Specific Requests for Human Medicines
11/06/2008 Guide to the Registration of Homeopathic Medicinal Products
11/02/2008 Guide to the Definition of a Human Medicine
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Date Printed: 24 May 2013

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