Note – for information on the compilation of eCTD dossiers please follow this link

Documents to be submitted

Submission of an application for abridged assessment of an active pharmaceutical ingredient master file (APIMF), previously submitted under the APIMF procedure, and now submitted for API prequalification, involves preparation and submission of a number of documents in electronic format, as follows:

• 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 either:

1. On CD or DVD to:

World Health Organization
WHO Prequalification Unit: medicines
MHP/RPQ/PQT Room M613
20, Avenue Appia
1211 Geneva 27
Switzerland

Please include a paper cover letter with the CD/DVD submission to facilitate processing.

or

2. Via a secure link to an online document repository. The link should be sent in an email to the following email address: APIassessment@who.int. The subject line of the emails should clearly indicate the application and the specific medicine procedure referred to. The date of receipt will be the date the file is successfully downloaded.