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Special Mail 5: Guidelines on submission of applications to the MHRA

Document details:

Type: Publication
Series No: 5
Audience: Pharmaceutical industry
Published: 31 July 2006
Format: Electronic and paper
Size: A4
Pages: 14
Price: Electronic free, subscription for print
ISBN/ISSN: 1360-8738
Author: MHRA
Copyright: Crown
   

Related information:

In this issue:

Types of submissions covered
Sending submissions
Structuring data on disk
Posting disks
Labelling disks

Special MAIL 5 should be read in conjunction with the Frequently Asked Questions (version 2 - December 2007) document below.

Submissions in non-XML electronic Common Technical Document (eCTD) format  - 14 March 2007
To help companies move to electronic Common Technical Document (eCTD) working, the MHRA will now accept electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but which do not have an XML backbone. For further guidance, please see the document below.

Page last modified: 28 December 2007