Documents to be submitted
Submission of an application for abridged assessment of an active pharmaceutical ingredient master file (APIMF), previously approved by an Authority applying stringent standards for API prequalification, involves preparation and submission of a number of documents in paper and/or electronic format, as follows:
- the covering letter (paper format)
- a completed API prequalification application form (in both Word and PDF format)
- the APIMF currently accepted by the European Directorate for the Quality of Medicines & HealthCare (EDQM) or the United States Food and Drug Administration (US FDA) and that will serve as the base document for any future amendments
- a copy of the letter to EDQM or US FDA authorizing sharing of the APIMF assessment report with WHO
- a chronological summary of the assessments that were undertaken by the Agency during initial approval or when changes were made, following approval
- a summary of any changes made over time to the details of the APIMF submitted to the Agency
- if applicable, a summary of the differences between the details of the APIMF submitted to WHO and those of the APIMF currently accepted by the Agency
- a site master file for each manufacturing site (in Word or text-selectable PDF)
- evidence of GMP inspection carried out within the past three years by a member of the Pharmaceutical Inspection Co-operation Scheme (PICs) for each manufacturing site in lieu of a request for inspection of each manufacturing site by WHO.
Please note that minor differences between the details currently held by the Agency and those that are being submitted to WHO are permissible.
Following receipt of the application, WHO will contact the Agency and request that it provide access to its assessment report.
The applicant may provide information additional to that outlined above, provided it is clear and well summarized.
Where to send an application for product evaluation of an API and responses to requests for further information
An application for the APIMF procedure and subsequent responses to questions raised by WHO assessors should be sent to:
World Health Organization
WHO Prequalification Team: medicines
HIS/EMP/RHT/PQT Room 613
20, Avenue Appia
1211 Geneva 27