Senegal
Official Name: Republic of Senegal
Capital: Dakar
Independence Day: 20 June 1960
Currency: CFA franc (XOF)
Indicators
Regulatory Framework
The Department of Pharmacy and Laboratories (DPL) is the regulatory authority that oversees medicine regulation in Senegal. It performs the following regulatory functions: marketing authorization, inspection, licensing, import control, pharmacovigilance, market and quality control, and clinical trials.
Market Authorization/Registration
An applicant can apply for a new marketing authorization, marketing authorization renewal or a marketing authorization for a variation of an already registered product. The Division of Pharmacy and Medicine then examines the application and sends the relevant files to the laboratories for testing. Thereafter, the product files are sent to a committee of experts who generate an evaluation report. The National Medicine Commission express their opinions on all market authorization requests received, which are consolidated into a report. This report is then sent to the Minister of Health for endorsement.
Inspection
The Pharmacy Inspection Office is responsible for inspections in Senegal. Inspection is required by law and it is a pre-requisite for public and private establishments to receive licensing. The Inspection Office is charged with the inspection of pharmacies, hospital pharmacies, public and private establishments manufacturing, distributing or wholesaling pharmaceutical products, medicine for medical analyzes, drug stores and, in general, all the places where medicines and poisonous substances are prepared, kept, sold or distributed; to oversee the application of laws and regulations in the field of pharmacy and medicine and to deal with related disputes and to organize and participate in the fight against the illicit market in medicines and the illegal practice of pharmacy.
Licensing
There are legal provisions that require importers, wholesalers, distributors, pharmacists and local manufacturers to be licensed. There is also legislation that requires both domestic and international manufacturers to comply with GMP guidelines, and wholesalers and distributors to comply with Good Distribution Practices.
Import Control
Legal provisions exist requiring authorization to import medicines into the country. However, there are no legal provisions that authorize the sampling of imported medication for testing. The imported medicines are also not required to be inspected at the ports of entry.
Market and Quality Control
There is a laboratory, which is a part of the NMRA, where medicine samples are tested. The National Laboratory collaborates with the collaborate with the WHO preselection program. Medicines samples are tested for the following reasons:
• For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities)
• For quality monitoring in private sector (routine sampling in retail outlets)
• When there are complaints or problem reports
• For product registration
• For public procurement prequalification
• For public program products prior to acceptance and/or distribution
• For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities)
• For quality monitoring in private sector (routine sampling in retail outlets)
• When there are complaints or problem reports
• For product registration
• For public procurement prequalification
• For public program products prior to acceptance and/or distribution
Pharmacovigilance
The National Pharmacovigilance System (SNPV) of Senegal was set up in 1998 by ministerial decree. This system is coordinated by the Directorate of Pharmacy and Medicines. A National Pharmacovigilance Guide can be found on the Division of Pharmacy and Medication website. The document articulates, among other things, general information on pharmacovigilance, the roles and responsibilities of various actors in pharmacovigilance and the pharmacovigilance investigation and monitoring procedure.
Clinical Trials
There is no legislation that requires the regulatory authority to authorize clinical trials. Nevertheless, performing clinical trials requires the approval of a committee of ethics / a review board institutional.
Information Management System
The Division of Pharmacy and Medicine has a website where applicants can download application forms, access guidelines, and get general information about medicines. The DPL answered in the WHO Pharmaceutical Sector Questionnaire that it has an IMS that supports its regulatory processes, however, further information on this system is not given.