Special Mail 5: Frequently Asked Questions (version 2.1 - June 2009)

Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

This version contains amendments to the Special Mail 5 FAQs version 2.

Amendments in version 2.1:

  • Paper submissions and text-searchability requirements…
  • Submitting SmPCs, PILs, labels & Variations...
  • Responses to RFIs...
  • Clinical Trials… - Updated v2.1
  • Withdrawals and Cancellations... - New (new in v2.0)
  • Annex A – List of CTD file names – m131 update - for text-searchability - see Annex D
  • Annex B – Module 1.2 Annex Documents - Updated v2.1
  • Annex G – Updated submission route summary - Updated v2.1

 

Page last modified: 10 June 2009