Submission Procedure – Abridged Assessment of an APIMF Previously Submitted to WHO Using APIMF Procedure
1. eCTD submissions
The preferred format for APIMF applications submitted to PQT is in eCTD format.
Information on documents expected in an eCTD formatted APIMF application, and other guidance related to eCTD can be located on the dedicated eCTD webpage
2. Non-eCTD submissions
APIMF applications may still be submitted in non-eCTD format until approximately May 2026.
3. 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:
| Cover letter | Mandatory |
| Application Form | Mandatory |
| Manufacturing Authorisations/Registrations/CPPs | Optional |
| Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP) (including any annexes) | Optional |
| Letters of access for active pharmaceutical ingredient master files (APIMFs) | Optional |
| Good manufacturing practices (GMP) information | Optional |
| Summary of Changes document | Optional |
| Previous Commitments | Optional |
| NRA approval | Optional |
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, and APIMF amendment should be submitted and accepted before the application for prequalification is made.
4. Where to send an application for product evaluation of an API and responses to requests for further information
Applications and subsequent responses to questions should be created and submitted via the ePQS Portal.
Further information on the ePQS Portal, including how to make submissions are available at the Portal