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MSF Quality Assurance

General principles

As a medical organisation, MSF regularly dispenses/uses medical products: medicines, medical devices and specialized medical food to patients in the programmes it runs all over the world. MSF attaches the utmost importance to the quality of these medical products used or dispensed to patients.

MSF strongly considers that any patient wherever s/he lives has the right to be treated with effective and safe medical products, and that it is the legal and moral responsibility of the organisation to guarantee the quality of the medical products used and distributed in its programs. 

Like many other humanitarian actors, MSF is aware that the quality of medical products is not always properly guaranteed on the global market. To this end, MSF has set up its own centres for international supply, which are in charge of the purchase, storage and shipment of products for MSF to carry out its missions: MSF Logistique in France, MSF Supply in Belgium, and Amsterdam Procurement Unit in The Netherlands. Their objective is twofold:

  • Operational: to procure and supply medical and non-medical products to MSF projects in a timely manner.
  • Qualitative: to ensure the compliance of the products with MSF's technical requirements following international standards and to monitor their quality.

MSF procurement policy 

MSF Procurement policy’s main principle is that, by default, MSF procures internationally through its supply centers the medical products approved through the MSF qualification. 

MSF complies with all applicable national regulation concerning importation processes as defined by the National Competent Authority and in accordance with the  countries’ Memorandum of Understanding (MoU) and, where existing, the MSF Host Country Agreement (HCA). 

In some countries, however, MSF is not authorised to import medical products. In that case, the legal responsibility to assure the quality of the medical products rests with the National Medicines Regulatory Authorities. Within that frame, MSF applies a specific local procurement validation procedure.

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.

MSF’s Policy for In-Kind Donations of Medical Products and Health Technology pdf — 213.13 KB Download

Management of Quality Complaints and Non-Conformities

MSF follows a Procedure for the Management of Quality Complaints and Non-Conformities, and to handle recall of medical products, applicable at both the Supply Centres conducting international procurement and projects level. 

MSF requires from its suppliers to have a traceability system in place and a procedure for monitoring of quality complaints and to trigger recalls.

Pharmacovigilance 

Adverse drug reactions and drug quality issues are closely monitored in MSF projects.  

These situations are timely investigated, usually in collaboration with the drug manufacturer(s), local and central MSF pharmacists and the drug regulatory agencies where MSF works (as applicable), to determine the root cause of the issues and the appropriate corrective and preventive actions.

MSF Medical product storage guideline

MSF has developed internal guidelines for Good Storage and Distribution Practices based on WHO Good storage and distribution practices for medical products, 2020. There is also regular training provided internally.