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Information dated 07.12.2006 |
Drugs procurement - General principles
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Médecins Sans Frontières (MSF) is a humanitarian organization implementing medical programs in more than 70 countries around the world.
MSF has its own procurement centres, in charge of the purchase, storage and shipment of drugs, vaccines, specialized food items, laboratory reagents and equipments, medical material and equipments and all the goods necessary for MSF to carry out its missions
In order to guarantee the quality of the drugs used by MSF, the general policy of the organization is to select its own sources of pharmaceuticals and supply these products to its teams wherever they operate and wherever MSF is authorized to import pharmaceuticals
If you wish to supply medicines to MSF, first read carefully this page explaining the MSF qualification procedure to verify that your company will meet MSF requirement, and to be informed on how MSF qualify its pharmaceuticals;
MSF qualification scheme is a classical two steps procedure including:
The assessment of the manufacturing site for compliance with WHO Good Manufacturing Practices(GMP)
The assessment of the product dossier
This MSF Qualification Scheme has been developed in the specific context of an NGO with human resources, infrastructures and an operating system that enable it to keep control over the whole supply chain, from the procurement to the dispensation of drugs.
The scope of the MSF Qualification Scheme is limited to the drugs that are to be purchased by MSF Procurement Centres and supplied to MSF medical programmes.
MSF qualifications are only valid for this specific working context and are granted for a limited period of time.
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 Procurement Centres supplier.
Those who want to do so are invited to read the MSF Qualification Scheme and to download the MSF Manufacturer Information File (MIF) available there.
Completed MIF should be sent by electronic mail or by post together with the requested annexes to
MSF International Pharmaceutical Coordination
8, rue Saint Sabin
75011 Paris
France
coordo-pharma@msf.org
MSF is working with a limited number of essential medicines: List is here
The expressions of interest for products that are not included in the list will not be considered
Qualification of the pharmaceuticals
The MSF qualification of pharmaceutical products is manufacturing site specific.
The assessment of the manufacturing site for compliance with WHO GMP is the necessary first step of the evaluation.
MSF usually appoints independent experts to conduct GMP audits.
However, the intention is not to duplicate the work of stringent regulatory authorities or the WHO pre qualification team.
The outcome of recent WHO PQ , PIC/S or ICH members inspections (conducted in the last 24 months) can be taken into consideration for the evaluation of the manufacturing site.
Only products that are manufactured in WHO GMP compliant facilities will be evaluated.
Any product that is pre-qualified by the WHO PQ or that is registered in a highly regulated country is automatically qualified by MSF.
Products not WHO pre qualified nor registered in a highly regulated country and presenting an interest for the organization will be fully evaluated by the MSF pharmacists.
The evaluation is carried out against WHO norms and standards.
Details of the evaluation are given in the MSF Qualification Scheme.
Outcome of the evaluation
An MSF qualified product can be:
A product that has been pre qualified by the WHO
A product registered in a highly regulated country
A product that meets the WHO norms and standards and successfully passed the MSF evaluation
The qualification of a product is formalized by the signature of a "Product Specification Sheet" (PSS) that summarizes the characteristics of the product as approved by MSF pharmacists.
The MSF qualification is an ongoing procedure and qualifications are granted for a limited and specified period of time.
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.
Commercial negotiations and purchase
Only the manufacturers whose products have been qualified by MSF pharmacists will be invited to participate to commercial negotiations.
FOOTNOTES:
1 WHO Pre Qualification Project (http://mednet3.who.int/prequal/)
2 Pharmaceutical Inspection Cooperation Scheme (www.picscheme.org)
3 International Conference for Harmonization (www.ich.org)
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