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 1. The approach taken is to add, in addition to the previous section bookmarks, a list of major, important or useful changes, also bookmarked. All updated questions are marked as such, and question numbers in each section are now prefixed with the section number for ease of reference.
Several points for clarification have been raised via telephone conversations with the MHRA, e-mailed requests for further details, conferences and meetings with industry. This constructive feedback is appreciated, and we hope it continues.
A significant evolution is the addition of a new section on text-searchability of documents, compiled by the ABPI - this is included in the list of major amendments below.
- Acceptance of NeeS as “Submissions in non-XML eCTD format”
- 25 MB size limit preference on PDF files
- M1 DTD v1.2.1 documents in NeeS
- Clarification of file-naming in bulk submissions
- Letter.Access@mhra.gsi.gov.uk (e-mail box)
- PSUR updated guidance
- Responses to RFIs additional guidance
- Basic Portal tips
- 10. Clinical Trials…
- 13. Withdrawals and Cancellations… - new, & Withdraw.Cancel@mhra.gsi.gov.uk (e-mail box)
- 14. Parallel Import Applications… - new
- 15. Information Updates (Add/Amends)… - new
- Annex A - List of CTD file names - text-searchability columns removed - see Annex D
- Annex C - CTA Document Naming Conventions - updated
- Annex D - Guidance on Text Searchable Documents for MHRA Submissions - new
- Annex E - List of PLPI file names - new
- Annex F - List of documents required for different PLPI variations - new
- Annex G - Updated submission route summary - new
We have also included a substantial section on PLPI submissions, a revision of the CT section, and an up-to-date summary of submission routes.
