Submission Procedure ‒ Change to an Innovator or Multisource (Generic) FPP Prequalified on Basis of SRA Approval

Documents to be submitted

WHO should be informed as soon as a variation has been approved by the relevant SRA and provided with the following documents:

  • a covering letter (in paper format)
  • a labelled CD or DVD containing:
    • a completed notification form, signed by the designated representative of the applicant, in both Word and PDF formats
    • a copy of the regulatory acceptance letter
    • an updated quality information summary (QIS-SRA)* (in Word format)
    • if the change affects any information included in the summary of product characteristics (SmPC), patient information leaflet (PIL) and/or labelling, a copy of the amended SmPC, PIL and/or labelling should be provided in Word format, showing changes in track change mode, as well as a certified clean English language version of the latest product information (in Word format). If the product information is publicly available in English on the SRA's website, submission of the updated product information (e.g. SmPC/PIL) can be waived  if the weblink to the product information on the SRA website is provided.

WHO should be informed immediately of any changes to the name and contact details of the person responsible for responding to WHO regarding issues related to the product.

* The QIS-SRA provides a condensed summary of key information on the FPP as approved by the reference SRA. The QIS-SRA 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. If a variation for an FPP that was prequalified via the SRA route, and before implementation of the QIS-SRA, and that affects the QIS-SRA, is approved by the relevant SRA, a QIS-SRA template should be completed in full, and the revised sections highlighted.

Where to submit the application

The application for variations should be sent to:

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.

WHO will send an email acknowledgment of receipt to the applicant within 45 calendar days. In some instances, further information regarding the variation may be requested.

WHO should be informed immediately of any changes to the contact details of the person responsible for communicating with WHO regarding issues relating to the product.