Skip to main content

Home

Home

AMRH Site Header Menu

  • Home
  • Who We Are
  • Our Focus
    • African Medicines Agency
    • AMRH Technical Committees
      • ABRF TC
      • AVAREF-TC
      • AMDF-TC
      • AMQF
      • IMS-TC
      • EMP-TC
      • GMP TC
      • MPRR-TC
      • RCD-TC
    • RCOREs
    • AMRH Partnership Platform
  • What We Do
  • Resources
    • FRPath® Project.
SEARCH BY
Mauritania Mauritania

Official Name: Republic of Mauritania
Capital: Nouakchott
Independence Day: 28 November 1960
Currency: Ouguiya (MRO)

  • Indicators

Indicators

Regulatory Framework

The authority in-charge of pharmaceutical regulations in Mauritania is called the Directorate of Pharmacy and Laboratories. The authority is a semi-autonomous institution with responsibilities in licensing, pharmacovigilance, medicine inspection, import and export control, quality and market control and clinical trials. It is also in charge of implementation of national and international legislation to fight against narcotic drugs and psychotropic substances and promotion of the use of traditional medicines improved.

Market Authorization

All pharmaceutical products distributed across the country are required to have a market authorization certificate. Requests for the authorization of pharmaceutical products are assessed based on the criteria, which is available to the public. However, the law defines the frequency of the publication of the product list of approved pharmaceuticals. Applicants for authorization are required to pay a fee and to provide information on the changes of the existing authorization. The application must be attached with a certificate of compliant pharmaceutical product to the WHO certification system. A committee of experts in market authorization handles the process. However, in situations where they declare conflict of interest and disapprove the authorization, the candidate is allowed to appeal on the authority’s decision.

Clinical Trials

Clinical trials are authorized by the authority of pharmaceutical regulation. Carrying out clinical trials requires committee approval of ethics / of an examination board. Test are conducted and recorded within the clinics in the registry international / national / regional. The products examined must be GMP compliant and the sponsor, the researcher must comply with good clinical practices (GCP). Relative national regulations to PCBs is published by the authority. The law authorizes the inspection of establishments where clinical tests are performed.

Import Control

The import of medicines is subject to authorization. The law provides for the levy samples of imported products for review. The import of medicines is limited to authorized ports of entry. All imported pharmaceutical products must be inspected by the authorities at the authorized port of entry.

Information Management System

The regulatory authority in Mauritania does not have an independent website for sharing its activities and other information. However, the country relies on the MoH website: http://www.sante.gov.mr/?page_id=609 for information. The site contains information about the ministry, medication, strategies, planning of projects and monitoring and evaluation. There is no mention or link of the website to any regional regulatory harmonization program. Mauritania is part of the AMU regional community and benefits from its medicine regulation harmonization policies.

Mauritius

In Mauritius, there are legal provisions establishing the powers and responsibilities of the MRA. The MRA is a part of the MoH and of a semi-autonomous agency with the following functions: Marketing authorization/registration, inspection, import control, licensing, marketing control, medicines advertising and promotion, clinical trials controls, and pharmacovigilance.
The MRA does not receive any external technical assistance to support its activities. Funding for the MRA is provided through the regular government budget. This body does not utilize a computerized information management system to store and retrieve information on processes that include registrations, inspection and other regulatory functions (World Health Organization, 2011).

AMRH Site Header Menu

  • Home
  • Who We Are
  • Our Focus
  • What We Do
  • Resources

CONNECT WITH US

Copyright © 2022 African Union Development Agency (AUDA-NEPAD). All rights reserved. | Terms & Conditions | Fraud Alert