Submission Procedure – SRA-Approved Multisource (Generic) or Innovator FPPs

Documents to be submitted

Submission of an expression of interest for evaluation of an FPP that has already received the approval of a stringent regulatory authority involves preparation and submission of a number of documents, in electronic format (i.e. on CDs or DVDs). The submission must be in English and must include officially certified English translations of product information and other documents, if applicable. In summary, these documents are:

  1. The covering letter, which should include:
    • a statement indicating that the information submitted is true and correct
    • a statement confirming that, for WHO prequalification, the FPP will, at the time of submission, be the same in all respects as the product registered with the relevant SRA
    • a statement indicating that the product is actually on the market of the reference SRA’s country or region.
  2. A copy of the marketing authorization or the equivalent thereof. 
  3. A copy of the current WHO-type certificate of a pharmaceutical product issued and fully completed.
  4. The latest SRA-approved production information.
  5. A list of the SRA-approved manufacturers of the FPP.
  6. A list of the SRA-approved manufacturers of the active pharmaceutical ingredient(s) used in the manufacture of the FPP.
  7. If available, a public assessment report.
  8. A tabular list of the batches manufactured for the market of the reference SRA’s region or country since approval or during the past five years, whichever is shorter.
  9. A sample of the product in market packaging, together with the respective certificate of analysis.
  10. A copy of the currently approved FPP specifications.
  11. A completed quality information summary (QIS-SRA).

In addition, in view of the need for WHO to advise procurement agencies and recipient countries on storage conditions, applicants are now also requested to submit:

  1. A copy of the stability data submitted for approval of the label storage condition and shelf life by the reference SRA. If available, zone IVb stability (data generated at 30+2°C/75+5%RH) on the primary or production batches of the product in the same packaging as approved for marketing of the FPP in the reference SRA’s country/region should also be provided. The data should be provided in tabulated format. If these data are not available at time of submission, applicants should initiate long-term stability testing zone IVb storage conditions, in the same packaging as approved by the reference SRA for marketing of the product, as soon as possible. The data can be submitted after prequalification of the product.

The QIS-SRA should be submitted in Word format so that WHO can insert questions, or requests for further data and explanation in the file, for the manufacturer's response. If the product information was not originally in English but has been translated, an English language version of the product information, should also be submitted in Word format. All other files can be submitted in PDF (portable document) format.

The first “folder” on the CD/DVD should consist of a table of contents.

Word files should not exceed 10 MB in size and should be sent to:

Attention: WHO Prequalification Team: medicines
Product Name: UNICEF Supply Division

Oceanvej 10− 12
2150 Nordhavn
Copenhagen
Denmark

Additional information

WHO may request additional data relating to use of the product in populations, settings or regions relevant for prequalified products.