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Page 1 of 5
Date Title
01/01/2002 Rejection Procedure for Applications
25/11/2002 Combining Parenteral Product Containers on one Product Authorisation : Guidance
13/01/2003 Incorporation of Safety Data in Product Information at Renewal/Variation : IMB Guidance
03/06/2003 Commission Regulations (EC) No 1085/2003 on Centralised Variations
14/04/2004 Variations: Submission of Type IA and IB Notifications for National Applications - IMB Guidance
10/01/2005 Change to labels and/or patient information leaflets not connected with changes to the SPC: Application Form
09/03/2005 Volume 2B Notice to Applicants- User Guide
03/06/2005 Electronic Submission Declaration
14/12/2005 Number of dossiers required : Guidance Document
19/04/2006 Product information requirements under Directive 2001/83EC as amended by Directive 2004/27EC- Further Guidance
16/01/2007 Annual Compliance Declaration for a Dual Pack import Registration
01/03/2007 Application for Renewal of a Marketing Authorisation
15/06/2007 Notice to Applicant-Module 1 (Part 1A): Volume 2B
07/09/2007 CMD(h) Notification form for changes under Article 61(3): Application Form
07/09/2007 CMD(h) Standard Operating Procedure - Procedure For Article 61(3) Changes To Patient Information
07/09/2007 MRFG Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures
07/09/2007 Notification form for changes under Article 61(3): National Form
30/09/2007 Guide to Transfer of Veterinary Product Authorisations
30/09/2007 Transfer Application Forms for Veterinary Medicines
30/09/2007 New product application form for Veterinary Medicines
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Date Printed: 24 May 2013

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