In order to avoid any duplication of work, any product that is pre-qualified by the WHO Pre-Qualification Programme (PQ) or that is registered in a highly regulated country is automatically qualified by MSF.
Products that are neither WHO pre-qualified nor registered in a highly regulated country and that present an interest for the organisation will be fully evaluated by the MSF pharmacists. The evaluation is carried out against WHO norms and standards. The evaluation includes two steps (details are given in the MSF Medical Product Qualification Scheme):
- The assessment of the manufacturing site for compliance with WHO Good Manufacturing Practices (GMP) is the necessary first step of the evaluation. Only products that are manufactured in WHO GMP compliant facilities will be evaluated. GMP inspections carried out by the WHO PQ inspectors, or inspectorates recognised by MSF are taken into consideration by MSF. For facilities which have not been previously inspected and approved by WHO PQ or a SRA inspectorate, the MSF International Pharmacist Coordinator appoints a GMP expert to perform an audit.
- The second step of the process is the evaluation of a product dossier according to standards set by WHO, and based on a standard Product Questionnaire common to the Interagency Pharmacist Group (UNICEF, ICRC, The Global Fund, WHO procurement center, UNFPA, GDF and MSF).
The qualification of a product is formalised by the signature of a “Product Specification Sheet” (PSS) summarising the characteristics of the product as approved by MSF pharmacists. The assigned PSS number is then used as a reference for procurement.
The MSF qualification is an ongoing procedure and products approved through a product dossier are monitored at regular intervals. Monitoring activities focus on the re-evaluation of the WHO GMP compliance of the manufacturing site and the updating of the information and data given in the product questionnaire.
Expression of interest
As a principle, each and every drug manufacturer is free and welcome to express his interest to be considered as a possible MSF European Supply Centres’ supplier.
Those who want to do so are invited to download the MSF Manufacturer Information File (MIF).
Completed MIF should be sent by e-mail or by post together with the requested annexes to:
Assistant to the QA coordinators
Rue de l’Arbre Bénit 46
1050 Brussels
Belgium
QA-Coordination-Assistant@msf.org
The expressions of interest for products that are not included in the list will not be considered.
Commercial negotiations and purchase
Only the manufacturers whose products have been qualified by MSF pharmacists will be invited to participate to commercial negotiations.
In-kind donations
MSF does not accept in-kind donations of medical products or health technology. Under exceptional circumstances, and on a case-by-case basis, MSF may consider accepting such donations according to the criteria and conditions set forth in MSF’s Policy for In-Kind Donations of Medical Products and Health Technology.
