eCTD Guidance Document - eSubmission - Europa

Figure A3-4 - Approach 1 - One 32p for all Strengths, any strength specific documents identified by the XML title, not by
adding an additional XML section
XML Files and Folders (directory)
Note: The use of the term ‘all-strengths’ will mean that if the applicant subsequently submits a line extension for an additional strength (e.g.
1000mg) where the documentation is significantly different, and approach 2 is preferred for the new strength, then the attribute ‘all-strengths’
will not include the documentation for the 1000mg tablet. An alternative would be to not use the term ‘all-strengths’ at all and just use ‘Tablet’
for the dosage form attribute. This implies all strengths and reduces the overall path length.
42 of 46