40
There are no blank pages or unexpected blank spaces (note: half empty pages are
acceptable if they occur in connection with tables or pictures)
There is no text in the header of the pages
Only page numbers appear in the footer of the pages, starting with ‘1’ (bottom, centre) on
the title page of Annex I, and the format is font Arial 8
Full set of annexes are provided as an integrated document in WORD TRACK CHANGED
files in all EU languages (incl. EN, NO & IS) in one ZIP folder (containing 25 word files)
named as <PRODUCT NAME> day +25 (235) PI tracked all languages
Full set of annexes are provided in PDF CLEAN files in all EU languages (incl. EN, NO & IS)
in one ZIP folder (containing 25 PDF files) named as <PRODUCT NAME> day +25 (235) PI
PDF all languages
PDF files follow the naming convention emea-combined-h–xxx-<language code> and
bookmarks and document properties are added
Annex A (if applicable)* is provided as separate document with the cover page ‘Annex A’
removed in PDF CLEAN files in all EU languages (incl. EN, NO & IS) in one ZIP folder
(containing 25 PDF files) named as <PRODUCT NAME> day +25 (235) Annex A PDF all
languages
PDF files follow the naming convention h-xxx-AA-<language code> and document
properties are added
*Where additional changes to the day +5/215 files have been made, submit full set of
revised Annex A in WORD TRACK CHANGED files in all EU languages (incl. EN, NO & IS) in
one ZIP folder (containing 25 word files) named as <PRODUCT NAME> day +25 (235)
Annex A word tracked all languages
Annex 127a (if applicable) is provided as
separate document with ‘127a’ removed in WORD TRACK CHANGED files in all EU
languages (incl. EN, NO & IS) in one ZIP folder (containing 25 word files) named as
<PRODUCT NAME> day +25 (235) Annex 127a all languages
separate document with ‘127a’ removed in PDF CLEAN files in all EU languages (incl. EN,
NO & IS) in one ZIP folder (containing 25 word files) named as <PRODUCT NAME> day
+25 (235) Annex 127a PDF all languages
PDF files follow the naming convention h-xxxx-Art127a-conditions-<language code>
and document properties are added
Separate WORD file with the completed table of International non-
proprietary/Common name of the active substance translations in all languages (if
applicable and requested in the Day 210 letter to MAH)
The QRD Form 2 is attached as WORD file with section 1 completed in all parts
Where appropriate, supporting documents are attached
The linguistic review process of product information in the centralised procedure – human
EMEA/5542/02/Rev 5
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