Submission Procedure – Application for Variation or Change for a Multisource (Generic) FPP

Documents to be submitted

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

  • a covering letter (in paper format)
  • a labelled CD or DVD containing:
    • for variations classified as Vmaj, Vmin or IN: a completed variation application form, signed by the designated representative of the applicant, in both Word and portable document (PDF) formats
    • for variations classified as AN: a complete annual notification form, signed by the designated representative of the applicant, in both Word and PDF formats
    • an updated quality information summary (QIS), if applicable,* in Word format
    • supporting documentation in CTD format, if applicable, and as specified in the variation guidelines, in PDF format (preferably 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, and submitted as part of the variation package with any revised sections highlighted. 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

The application for a variation should be sent:

in an electronic version (i.e. on CD or DVD) to:

World Health Organization
WHO Prequalification Team: medicines
HIS/EMP/RHT/PQT Room 613
20, Avenue Appia
1211 Geneva 27
Switzerland

and to:

Attention: WHO Prequalification Team: medicines
Product Name: 

UNICEF Supply Division
Oceanvej 10− 12
2150 Nordhavn
Copenhagen
Denmark