Documents to be submitted

The following documents should be provided with each application for a variation:

• a covering letter
• a completed variation application form, signed by the designated representative of the applicant, in both Word and portable document (PDF) formats
• an updated quality information summary (QIS), if applicable,* in Word format
• supporting documentation in common technical document (CTD) format, if applicable, and as specified in the variation guidelines, in PDF format (text-selectable)
• revised version of the summary of product characteristics, of the patient information leaflet and/or labels if these are affected by the variation(s), together with a list of all revisions that have been made to the original documents, and a statement confirming that no other changes have been made to these documents (in Word or text-selectable PDF format).

Documentation of each change should be sufficiently detailed to enable the WHO assessor to quickly determine whether the appropriate reporting category has been used.

* The QIS provides a summary of the key quality information from the product dossier. For FPPs that have an agreed QIS, the QIS should be revised whenever information changes in any of the QIS sections. A revised QIS with track changes and clean version should be submitted as part of the variation package and the change history updated. If there is no change to the QIS as a result of the variation, a statement should be made in the variation application form to this effect. But please note: (1) If no agreed QIS was made available at the time of prequalification of the FPP concerned, a QIS is not required for submission of a variation. (2) However, if a QIS was made available through requalification of the FPP concerned, a revised QIS should be submitted with the variation.

Electronic requirements

No single electronic file should exceed 50 MB in size.

File or folder names should not exceed 64 characters in length.

Path lengths should not exceed 180 characters, including the file name, and extension. Abbreviated file or folder names can be used.

The use of special characters in folder or file names should to be avoided in order to prevent software conflicts. These special characters include:

• angle brackets (<>)
• ampersand (&)
• asterisk (*)
• backslash (\)
• braces ({})
• colon (:)
• forward slash (/)
• number sign (#)
• percent (%)
• plus sign (+)
• pipe (|)
• question mark (?)
• quotation mark (")
• tilde (~).

Where to submit the application

Applications and subsequent responses to questions should be created and submitted via the ePQS Portal. 

Further information on the ePQS Portal, including how to make submissions, is available at the Portal

Note – for information on the compilation of eCTD dossiers please follow this link