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Date Title
24/04/2013 Display of chemical group symbols on product literature of sheep anthelmintics
06/03/2013 Guide to refusals and appeals
23/01/2013 Guide to electronic submissions - veterinary medicines
14/01/2013 Guide to electronic submissions - human medicines
17/02/2011 New Variations Regulations - Key Points to Note
17/02/2011 Important links to documents related to new Variations Regulation
29/11/2010 Application for a Variation to a Registration Certificate for a Homeopathic Medicinal Product
04/03/2010 Variation application form for Herbal Medicinal Products
08/01/2010 Application for variation to a marketing authorisation
08/01/2010 Application for Variation to a Marketing Authorisation
18/12/2009 New Variations Regulation - key points to note
07/09/2007 CMD(h) Notification form for changes under Article 61(3): Application Form
19/04/2006 Product information requirements under Directive 2001/83EC as amended by Directive 2004/27EC- Further Guidance
14/04/2004 Variations: Submission of Type IA and IB Notifications for National Applications - IMB Guidance
03/06/2003 Commission Regulations (EC) No 1085/2003 on Centralised Variations
13/01/2003 Incorporation of Safety Data in Product Information at Renewal/Variation : IMB Guidance
25/11/2002 Combining Parenteral Product Containers on one Product Authorisation : Guidance
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Date Printed: 18 May 2013

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