Documents to be submitted
Submission of an application for abridged assessment of an APIMF, previously submitted under the APIMF procedure, and now submitted 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 labelled CD or DVD containing:
- the covering letter (in Word or text-selectable PDF (portable document) format)
- a completed API prequalification application form (in both Word and PDF format)
- a site master file (SMF) for each manufacturing site (in Word or text-selectable PDF)
- evidence of compliance with WHO Good Manufacturing Practices (GMP), or a request for inspection by WHO for each manufacturing site (Word or text-selectable PDF).
Submission of an APIMF is not required but the applicant should have already ensured that the APIMF held by WHO is fully up to date. If the APIMF is not up to date, an APIMF amendment should be submitted and accepted before the application for prequalification is made.
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