Precedent (Clinical Trials Approved/Denied in Last 2 Years)
7 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
A marketing authorization application dossier (DE0501) is accompanied by a cover letter (DE 0500) signed by the Director of the Department of Pharmacy and Medicines (DPM). The cover letter recalls the terms for submission of applications, what is the objective of the application, contact information and opening times.
The following documents are required for the registration of the application together the dossier:
DE 500: sample letter accompanying the dossier’s type of MA application
DE 501: a sample of the marketing authorization application
DE 502: form attesting that the application has been received
DE 503: form for the “notice of incomplete dossier”
DE 517 and DE 518: forms on samples’ delivery
"Order No. 05-2203/MS-CRM-SG 20 September 2005 Determining how to apply permissions on the market (AMM) medicinal products for human and veterinary use" outlines the necessary application materials for registration. (in French).
Product Registration Timelines
According to the MoH's Order No. 05-2203/MS-CRM-SG, the applicant will be informed of the MoH's decision within two months of the session in which it was discussed.
Post Registration Pharmacovigilance Requirements
The National Public Health Laboratory Drug oversees medicine quality in Mali. Please refer to this 2011 World Bank Health, Nutrition, and Population Family (HNP) paper "Private Sector Pharmaceutical Supply and Distribution Channels in Africa: A Focus on Ghana, Malawi and Mali."
A WHO Guide to GMP is available (in French) here.
September 23, 2014.