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

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.

Guidelines on submission of labels and patient information leaflets - 15 October 2008
In order to further increase efficiency we have reviewed the submission standards with regard to applications containing labels and patient information leaflets (PILs) with a view to maximising the efficiency of our data input and assessment processes. Following this review we are issuing the following data format requirements for the submission of labels, leaflets and label-leaflets. For further guidance, please see the document below.