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Guinea Guinea

Official Name: Republic of Guinea
Capital: Conakry
Independence Day: 2 October 1958
Currency: Guinean franc (GNF)

  • Indicators

Indicators

Regulatory Framework

The National Directorate of Pharmacy and Laboratory (DNPL) regulates medicines in Guinea. The authority is not autonomous from the Ministry of Health. The authority does not have a website of its own. The regulatory functions performed by the DPNL are marketing authorization, licensing, drug promotion and adverting, import control, market and quality control, inspection and pharmacovigilance.

Market Authorization/Registration

There are legal provisions that insist that all drugs on the Guinea market need a marketing authorization. There are explicit, accessible criteria to the public, for the assessment of marketing authorization applications for pharmaceuticals. The MRA is required by law to publish a list of registered pharmaceutical products. This list is to be updated every year. Medicines are always registered by their INN) or by the Brand name and the INN.

Inspection

Inspections of public and private facilities are required by law and are a prerequisite for the facilities to be licensed. Establishments that inspections are carried out on are local manufacturers, retail distributors, private wholesalers, pharmacies and warehouses, pharmacies and dispensing points for health establishments.

Licensing

Manufacturers are required by law to be licensed and to comply with Good Manufacturing Practices. Importers, distributors and wholesalers. Wholesalers and distributors are required to comply with Good Distribution Practices (GDP)

Import Control

There are legal provisions imposing an import authorization for medication. It is also required by law to take samples of imported medicines for testing. Pharmaceuticals also have to be inspected at the ports of entry.

Quality Control

There is a laboratory which is an operational unit of the NMRA at where medicine samples are tested. The DNPL sometimes cooperates with the Humanitarian Center of Pharmacy (CHMP) in Clermont-Ferrand, France, for the control of certain products. Drug Samples are collected by government inspectors for analysis as part of post-market surveillance.

Pharmacovigilance

In Guinea, a market authorization holder (MAH) is not required by law to continuously monitor his products on the market to report adverse events. There are no laws on monitoring for adverse effects of medicines. There is no official pharmacovigilance centre in liaison with the NMRA. An official standardized form for reporting adverse events is used in Guinea. All reports are stored in a national adverse event database. These reports are also sent to the Uppsala Monitoring Centre.

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