Information and Guidelines

Expression of Interest (EOI) Lists

• Invitations for Expression of Interest (EOI)
  

  • How to submit an EOI

General information related to prequalification of medicines

• General procedure [pdf]
  

• How to participate in the Prequalification
  

• Where to send the Product Dossier, as well as APIMF documentation and Site Master File
  

• Dates of Copenhagen assessment sessions
  

• Confidentiality

• Meetings with PQP Assessors

  • Meeting Request Form

Prequalification guidelines related to medicinal products

• Prequalification guidelines

The APIMF procedure

• General information [pdf]

• Changes to the details of an accepted APIMF (amendments and updates)  [pdf]

Variations (changes) to prequalified medicines

• An introduction to the variation procedure

  • TRS943, Annex 6 - guidance on variations to a prequalified product

• Types of variations

• How to submit a variation

  • Variation application form

• Where to submit the variation application

• Grouping of variations

• Updated stability requirements for variations

• Information regarding API-related changes

  • APIMF-related Notification Form

• Clarification of minor variation 5c

• Clarification of minor variation 12

• Information regarding changes to the details of innovator FPPs or generic FPPs prequalified on the basis of approval by a stringent regulatory authority (SRA)

• A summary of changes to the procedure published in TRS943, Annex 6

Frequently Asked Questions (FAQs)

• FAQs on the prequalification of medicines for reproductive health

Principles for prioritizing dossiers within WHO Prequalification of Medicines Programme (PQP)

• Note on Prioritization of dossiers within PQP

Information for buyers of prequalified medicinal products

• Information for buyers

Information for procurement agencies

• Information for agencies