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Medicines and Related Products Act, 2014

País/Territorio
Gambia
Tipo de documento
Legislación
Fecha
2014
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Acceso-a-la-información Fraude Sanidad animal Institución Comercio interior Comercio internacional Envasado/etiquetado Monitoreo Salud pública Registro Higiene/procedimientos sanitarios Normas Transporte/depósito Restricciones para el uso Medicamentos
Área geográphica
Africa, Países menos desarrollados, Atlántico Norte, Sahel, Africa Occidental
Resumen

This Act regulates medicines and related products. The Act established the Medicines Control Agency. The Agency shall be the regulatory body for the products regulated under this Act, and shall in particular regulate all matters relating to efficacy, quality and safety of medicines and related products; regulate in accordance with this Act, the importation, manufacture, labeling, marking or identification, storage, promotion, sale and distribution of medicines and or any related product, materials or substances used in the manufacture of products regulated under this act; ensure that evidence of existing and new adverse events, interactions and information about pharmacovigilance of products being monitored globally, are analyzed and acted upon; ensure that, clinical trials on medicines and related products, and herbal medicines are being conducted in accordance with prescribed standards; foster co-operation between the Agency and other institutions or organizations and other stakeholders; approve and register medicines and related products regulated under this Act, manufactured within or imported into, and intended for use in The Gambia as mentioned in Schedules I, II, and III; examine, grant, issue, suspend, cancel and revoke certificates and licenses or permits issued under this Act; appoint inspectors and order inspection of any premises; promote the rational use of medicines and herbal medicines; establish and maintain the Gambia National Formulary and Pharmacopoeia; provide the public with unbiased information on products regulated under this Act; Control of advertisements of medicines and related products; prescribe standards of quality in respect of products regulated under this Act, Manufactured or intended to be manufactured or imported into or exported from the Gambia; maintain registers pertaining to regulation of medicines and related products prescribed under Schedule I, II and III under the regulations; be responsible for its human resource management and development; promote, monitor and ensure successful implementation of the provisions of this Act relating to medicines and related products; attend to and where possible, take legal measures on complaints made by consumers against manufacturers of products regulated under this Act; carry out such other functions as may be conferred upon the Agency by any written law or as are incidental to the performance of its functions under this Act; do such acts or take such measures as are, in the opinion of the Agency, necessary or expedient for the prevention of health hazards to consumers which may result from the consumption or use of low or bad quality medicines and related products regulated under this Act. The Act further provides for licenses and permits; medicines and related products; registration of medicines and related products; and clinical trials and safety monitoring.

Texto completo
Inglés
Página web
www.mca.gm