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Drugs and Related Products (Registration) Regulations, 2021. S.I. no. 64 of 2021.

País/Territorio
Nigeria
Tipo de documento
Reglamento
Fecha
2021
Fuente
FAO, FAOLEX
Fuente original
Federal Republic of Nigeria Official Gazette no. 131 of 2021.
Materia
Ganado, Alimentación y nutrición, Cultivos
Palabra clave
Control de calidad de los alimentos/inocuidad de los alimentos Toxicidad/envenenamiento Envasado/etiquetado Medicamentos Sanidad animal Registro Plaguicidas
Área geográphica
Africa, Atlántico Norte, Africa Occidental
Resumen

These Regulations make provision for the registration of drugs. "Drug" includes any substances of vegetable, animal or mineral origin or any preparation or admixture thereof manufactured, sold or advertised for use in: i) the diagnosis, treatment, mitigation, in man or animal; ii) restoring, correcting or modifying organic function in man and animal; iii) disinfections or the control of vermin, insects or pest; contraception. No drug product shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of these Regulations. Application for the registration of a drug product shall be made to the National Agency for Food and Drug Administration and Control (NAFDAC). Certain changes here listed (or as may be prescribed by the Agency) shall require a new application. No person shall import or manufacture a drug without having a valid Clinical Trial Certificate of Authorization. Application for a clinical trial shall be made to the Agency. Some additional rules concern importaion and placing on the market of drugs and stability testing, shelf life, expiration dating and storage statement of drugs.

Texto completo
Inglés
Página web
www.nafdac.gov.ng

Referencias - Legislación

Implementa

National Agency for Food and Drug Administration and Control Act.

Legislación | Nigeria | 1993 (2004)

Palabra clave: Legislación básica, Control de calidad de los alimentos/inocuidad de los alimentos, Higiene/procedimientos sanitarios, Institución, Inspección, Comercio internacional, Medicamentos, Sanidad animal

Fuente: FAO, FAOLEX

Food, Drugs and Related Products (Registration, etc.) Act.

Legislación | Nigeria | 1993 (2004)

Palabra clave: Control de calidad de los alimentos/inocuidad de los alimentos, Toxicidad/envenenamiento, Comercio internacional, Comercio interior, Registro, Inspección, Agua mineral, Infracciones/sanciones, Medicamentos, Alimentos para animales/piensos, Sanidad animal, Abastecimiento de agua, Agua potable

Fuente: FAO, FAOLEX